How Much Omega 3 DHA Do Pregnant Women Need? New research says a lot more than 200 mg

OmegaMatters: Episode 7

Hosts: Drs. Bill Harris & Kristina Harris Jackson

Guest: Dr. Susan Carlson


Background and Key Takeaways:

Dr. Bill Harris and his daughter, Dr. Kristina Harris Jackson, are joined by Dr. Susan Carlson.


Guest Bio:

Dr. Susan Carlson:

Dr. Carlson is a giant in the field of omega-3 fatty acids, particularly as they affect the early stages of life, from pregnancy through birth. In the latest study she published in EClinicalMedicine, a Lancet Journal, she asked the question of whether or not the 200 mg DHA dose that is typically given to women who are pregnant is enough or if 1000 mg is superior and has better health outcomes for mom and baby in relation specifically to early preterm — birth before 34 weeks — and preterm birth — birth before 37 weeks. Those who had low DHA status seemed to benefit the most. And 1000 mg of DHA was definitely superior to 200 mg in preventing early preterm birth. 



Dr. Kristina Harris:        Welcome to OmegaMatters. I’m Kristina, this is Bill. And today we’re talking to one of the giants in the Omega-3 research field, Susan Carlson. We’ll talk to her about a recent publication, what she sees coming next in the field and, how to use her research clinically. So Susan, welcome to a OmegaMatters and thank you for talking to us today and you and my dad have quite a history. So you guys can fill us in on that a little bit.

Dr. Susan Carlson:        Yes. Well, I mean the way I think about our history is we changed institutions. We went across the State line at sort of the same time and we’d done a meeting together but I think it was a joke for years because I, even though we worked a mile apart, I mainly saw Bill in the Amsterdam airport or various meetings.

Dr. Susan Carlson:        I think there was an era where we were all on the road a lot.

Dr. Susan Carlson:        And, so that’s kind of the joke that I always think about. I didn’t ever see Bill in Kansas City.

Dr. Bill Harris:                Well, right. And the gap between early human development and atherosclerosis is pretty big. And so we, we’re both interested in fatty acids, but in very different ends of life. And so we didn’t have as much together. I always feel, I always feel bad when I think back on our 2008 conference and how you and I had this great idea to propose this fall conference in Kansas City. And we convinced the board to do it and ready to go. And then I left town.

Dr. Susan Carlson:        That very day. Right after the board you said I’m moving.

Dr. Bill Harris:                It might would have been.

Dr. Susan Carlson:        That worked out ’cause I made you work anyway, but.

Dr. Bill Harris:                You made me work and it worked out wonderfully.

Dr. Susan Carlson:        And I liked your lecture yesterday because you’ve pulled them back together. You’re talking about premature birth and premature death. So maybe that’s, we’ll talk about premature birth today.

Dr. Bill Harris:                Exactly.

Dr. Kristina Harris:        Other than their personal connection being from Kansas city and both interested in omega-3s and fatty acids, I’ll provide some background on Susan. She’s been in the area of omega-3 and omega-6, fatty acids, in the field of early life health for both mom and baby. The majority of her career, a PhD in nutrition and currently the AJ Rice Professor of Nutrition and in the KU Department of Dietetics and Nutrition at KU Medical Center. She just finished a term as the associate Dean of research in the KU School of Health Professions. And she’s been at the KU Medical Center for over 20 years, and really focused on fatty acids like DHA and arachidonic acid and their effects on brain development in infants and preventing preterm birth. So we highly recommend looking into her publications, if you want to see the depth and breadth of work, it’s very impactful. And we’re very excited to have her here today.

Dr. Bill Harris:                Let me also congratulate her for being elected a fellow of the American Society of Nutrition last week.

Dr. Susan Carlson:        So you were a fellow last year right now, but you were on the call yesterday.

Dr. Bill Harris:                Yeah, I was last year. Yeah, but you were long overdue. I was shocked when I got in that you were not in the list.

Dr. Kristina Harris:        There we go.

Dr. Bill Harris:                We corrected that problem.

Dr. Kristina Harris:        Well, so today we want to talk about your most recent paper. It’s published in EClinicalMedicine, which is the online journal for Lancet, I believe. And the title is “Higher dose to cause docosahexaenoic acid  or DHA supplementation during pregnancy and early preterm birth: A randomized, double-blind, adaptive-design, superiority trial.”  so a lot of scientific titles have a lot in there and this is no different.  let’s just start with the basic question you were asking in this study, what was your study about?

Dr. Susan Carlson:        Oh, so really our basic question was, is 200 milligrams of omega-3 DHA, which is becoming a standard dose in most prenatal vitamins that women take in the, in United States, is that adequate? Or is 1000 milligrams superior to reduce birth before 34 weeks. As you know, birth before 34 weeks are the babies who stay in the hospital longer. There, they’re more subject to a lot of problems like retinopathy of prematurity BPD, necrotizing enterocolitis. There’s a whole bunch of conditions that are really common.

The late preterm babies, those are the ones that are born after three, four weeks. They tend to stay maybe a week and go home to mom. And generally in the United States, they have a pretty good outcome.

Dr. Susan Carlson:        So that was our primary question.

Dr. Kristina Harris:        Right. The earlier they come out, the babies have less and less time to develop and there’s more that we have to do outside.

Dr. Susan Carlson:        Yes.

Dr. Susan Carlson:        And I’m glad we chose a superiority trial because we did not think a placebo trial would work in the United States. In the end, we found out that half the women in our study were taking DHA when we enrolled them. So I think that they probably would not have wanted to stop taking DHA and I would have felt it wasn’t ethical to tell them no.

Dr. Susan Carlson:        So we just gave everyone 200 milligrams and said, stop taking whatever you’re taking. Now we will guarantee you get the standard prenatal dose.

Dr. Bill Harris:                So that’s, that’s the superiority word in the title.

Dr. Susan Carlson:        Exactly.

Dr. Bill Harris:                And “adaptive” was the other word in the title too. What does that mean?

Dr. Susan Carlson:        So adaptive design is considered the ethical way to do clinical trials now, and it’s becoming more and more common. What it means is you assign more subjects to the “winning team,” so to speak.

Dr. Susan Carlson:        So when you have two arms like we did,  the reason it’s more ethical is because more women get assigned to what is probably the best outcome.

Dr. Susan Carlson:        And it’s also more efficient because you can finish the trial quicker , if you get a P-value that you decide on what probability you’re going to accept at the front end. But if the probability had been 0.9, we would have stopped the trial after 850 women.

Dr. Susan Carlson:        We didn’t achieve that, of course; it’s just an example.

Dr. Kristina Harris:        That’s how it works.

Dr. Bill Harris:                And so the assignment of women to treatment or placebo changes over time, as  somebody is looking in the background and tracking the outcomes — is that how that works?

Dr. Susan Carlson:        So, yes. So, they’re obviously in a blinded trial, you have to be careful about how you do this.

Dr. Susan Carlson:        So the way this trial was designed, after 300 women were equally assigned to 150 in each group, then every three months, there was a determination about whether one side was doing better than the other, and a new randomization schedule appended onto the last one.

Dr. Susan Carlson:        So that was done by people in the biostatistics department who really had no other involvement in the trial. So none of the PIs (principal investigators) or anybody working on a trial knew.

Dr. Bill Harris:                So you didn’t know as the ratio changed, you weren’t aware of it.

Dr. Susan Carlson:        Right. As the ratio was changing, we didn’t know which group was which.

Dr. Bill Harris:                Got it. Yeah.

Dr. Susan Carlson:        It could have been the 200 milligram group that was winning, right?

Dr. Susan Carlson:        Yeah.

Dr. Kristina Harris:        And so at the end of the day, 576 women got 1000 milligrams and 524 got 200 milligrams.

Dr. Susan Carlson:        Yes.

Dr. Kristina Harris:        They were recruited around the second half of their pregnancy.

Dr. Susan Carlson:        Yes. At least they had to be no more pregnant than 20 weeks gestation, but as early as 12.

Dr. Susan Carlson:        I think the average was right around four months pregnant.

Dr. Bill Harris:                Okay.

Dr. Kristina Harris:        What interesting about the fatty acid studies is often they are in the second half of the pregnancy versus the beginning of pregnancy. It’s nice that you could intervene midway in pregnancy and still see effects.  So let’s talk about basis of the study, let’s go into some of the results, and then we can talk a little bit more about how you guys did the statistics. ‘Cause you’ve just really pushed the boundaries on a lot of these statistical methods and we want to make sure we understand them.

Dr. Susan Carlson:        Yeah, so the main result was a 2.4% early preterm birth rate in the 200 milligram group and a 1.7% rate in the 1000 milligram group.

Dr. Susan Carlson:        There was a posterior probability that the 1000 milligram was better, but obviously that’s not the same as a probability of 0.99.

Dr. Susan Carlson:        In the meantime, the Australians published the ORIP trial and they published a secondary analysis from that trial which showed that the women with low status had an advantage that was statistically significant, but women with high status didn’t really have any advantage.

Dr. Susan Carlson:        So one of the things you’re allowed to do in a trial, if the trial is ongoing, you can change your protocol based on new information that’s come out. So we changed our protocol to say that we would do a subgroup analysis based on what would be low or high as per the ORIP definition.

Dr. Bill Harris:                Okay.

Dr. Susan Carlson:        And that’s still kind of considered a secondary analysis. It’s not the primary analysis, but the secondary analysis, you were allowed to do, and publish with your primary analysis. And what we found was that women who started with a DHA status in that low range had a dramatically lower difference in early preterm birth. It went from 4.1% in 200 milligram group down to 2% in the 1000 milligram group.

And the interesting thing was, and why it wasn’t more different in the group as a whole, is that the 53% or so of women who were above that status, it didn’t matter which dose they got. They had a very low rate of early preterm birth.

Dr. Bill Harris:                So it was about a 50/50 split above and below the status.

Dr. Susan Carlson:        Going back to the 2006 Kudos trial, 90% of the women were below 6% at baseline.

Dr. Bill Harris:                Oh, wow.

Dr. Susan Carlson:        And 10% were above. And to me, we knew that the prenatals had come into the market, but we had no way of knowing how that penetrated the sample we were looking at. And I think in some ways it strengthened the study because we got this dramatic effect of supplementation, even with 600 milligrams, and I think that’s partly because everybody was so deficient.

Dr. Susan Carlson:        In this particular trial, you could say half of the women were not particularly deficient in DHA.

Dr. Bill Harris:                All right.

Dr. Susan Carlson:        At the time we enrolled them, many of them were not because they had been taking DHA since they got pregnant, perhaps.

Dr. Susan Carlson:        We tried to catch them with their prenatal visit, which is a little bit later.

Dr. Kristina Harris:        And were you also, I’m just remembering a previous conversation, I think, where you were saying that the population that you recruited for your study, that the  whole population actually had a lower rate of preterm or early preterm birth than the general hospital population, is that right?

Dr. Susan Carlson:        That is true. Yes. The, the preterm birth rate in our hospital, I can’t tell you off the top of my head, but it’s in the 4 or 5% range.

Dr. Susan Carlson:        Uh, so 2.4% is very low. Now, remember there was nobody that was getting a placebo here.

Dr. Susan Carlson:        It may have been some women who weren’t taking their capsules, but  everybody was given either 200 or 1000 milligrams.

Dr. Susan Carlson:        So in the paper, we talk about the fact that, you know, we can’t say that 200 milligrams is beneficial, but the fact is we had such a low rate of early preterm birth in that group. And also it’s much lower than the US national average for preterm birth, which is somewhere around 3.5% for early preterm birth. So 2.4% is considerably below that. And, and you could infer from that that 200 milligrams was doing something, but of course we can’t prove that based on the way the study was designed.

Dr. Bill Harris:                Yeah. It could also be volunteers or, or different people than just the regular community patient. Right?

Dr. Susan Carlson:        No.

Dr. Susan Carlson:        II think it’s quite interesting because we had a full range of people from just a high school education to much higher education, and in fact we had two college professors in the trial.

Dr. Susan Carlson:        And I think we, we did a pretty good job of capturing a pretty generalizable population.

Dr. Susan Carlson:        When we considered all three sites together — Cincinnati, Ohio, and Columbus, Ohio, and Kansas City.

Dr. Susan Carlson:        But even within cities, there are differences. In the in the three sites we had, the Cincinnati population was a low SES (socioeconomic status) hospital population. Columbus was a pretty high income clinic. And then we had Kansas City, which was from our hospital and has a broad range of people with different backgrounds.

Dr. Susan Carlson:        At all three sites, women started with a different baseline status.

Dr. Susan Carlson:        So the Cincinnati group started lower. They were also less compliant. Whenever you’re dealing with the low SES population, you get that kind of result. The Columbus, Ohio, population had higher DHA status at baseline than ours, and they finished higher too. So they were very compliant.

Dr. Susan Carlson:        If we’d gone to a different site in Cincinnati where we were capturing the same kind of women as at Columbus, we would have had much different outcomes.

Dr. Susan Carlson:        So clearly taking it at the beginning and also very compliant.

Dr. Kristina Harris:        Yeah. It makes a difference.

Dr. Kristina Harris:        I also like how in the paper you do the number needed to treat analysis. So you, you say for the women who started out in the lower omega-3 status, you would need to treat with 1000 milligrams.

Dr. Susan Carlson:        Yes. That’s correct. I think it was an obstetrician who was one of the reviewers who asked us to put that in; it wasn’t our plan, but that person, that reviewer, wanted that number.

Dr. Susan Carlson:        And I think that’s the way people who are practical in taking care of patients think like, “Okay, if I recommend this to all my patients, how effective would it be?” So the number is, to prevent one for treating 43 is actually pretty good.

Dr. Bill Harris:                That’s pretty good.

Dr. Kristina Harris:        That’s very good, especially for a nutrient that’s relatively safe. There are definitely some things we’re looking at with higher and higher levels, but,  relatively safe and cheap to get. And then the number for the women who started off with a high DHA level for them, it would, you would have to treat 500 women at the highest.

Dr. Susan Carlson:        Exactly. Which means it’s probably not worth it, right?

Dr. Susan Carlson:        Even the 200 milligrams.

Dr. Susan Carlson:        But the one thing I will add to this is that in the secondary analysis, there was a pretty dramatic reduction in preterm birth (before 37 weeks gestation) with the higher dose. And we don’t want to minimize late preterm birth. It has its own risks. It’s just not as serious a situation, but in the developing world babies who are born preterm, that’s the major cause of infant mortality, because they don’t have NICU’s and all the support systems that we have in the Western medicine.

Dr. Bill Harris:                You found some other benefits as well for the 1000 milligram versus 200 milligram group on the other endpoints, the secondary endpoints.

Dr. Susan Carlson:        We looked at safety and that was one of the things you always do in a trial like this. And again, the posterior probabilities for the 1000 milligram dose being safer for mom were in the 0.8, to 0.89 kind of range.

Dr. Susan Carlson:        But for the babies, there were several outcomes that were significant. There was less risk to the infant in the higher dose group.

Dr. Kristina Harris:        And I don’t know if we were talking about this before we got on, and I don’t think we’ve fully come back around to it, but you keep saying posterior probability. And I don’t think we’ve defined that one yet.

Dr. Susan Carlson:        Yeah.

Dr. Kristina Harris:        Loosely defined, it’s kind of the cousin to a P-value. It’s trying to say the same thing as when we otherwise would use a P-value.

Dr. Susan Carlson:        We’ve all used P-values for all our scientific career, right?

Dr. Susan Carlson:        But the biostatisticians are… They’re both probabilities. They’re both talking about probabilities, but they’re determined in a different way. So the P-value is conditioned on the null hypothesis. That is, the chances you’re not going to find an effect.

Dr. Susan Carlson:        And the Bayesian posterior probability conditions on the observed data from the experiment.

Dr. Susan Carlson:        And the way I understand it is, the Bayesian results allow you to fit into the whole context of that research area. Whereas a P-value is kind of unique to that particular study.

Dr. Susan Carlson:        That you’re, you’re studying some outcome, but okay, you find in this study it doesn’t really tell you whether that study is an outlier or not.

Dr. Susan Carlson:        It doesn’t really help you get to the answer to your question, which is a health question, as well as the posterior probability question.

Dr. Kristina Harris:        It’s kind of like saying, in laymen’s terms, there’s an 80% chance that the 1000 mg of DHA was better than the 200 milligrams.

Dr. Susan Carlson:        Right. Well, we would say that probably the higher dose is better, but it does allow you to probe into it and see who’s really benefiting, which is what we did. And what we found is you probably don’t need to take the 1000 milligram dose if you’ve already been taking DHA for a while.

Dr. Susan Carlson:        The more data you can get the better, because it helps people understand kind of where they might be able to make a decision.

Dr. Kristina Harris:        Nutrition is not as black and white as maybe some other sciences where, in this case, we are talking about things like Omega-3s, which are in everyone’s body all the time, no matter what. It’s not like a drug where if you’re not taking the drug, it’s not in your body. So there’s always the spectrum that you’re then intervening on. And now we hear there’s a baseline creep for omega-3 DHA in the US where levels for pregnant women are increasing at least in certain populations, which is great, but that’s going to affect every study that’s trying to look at this.

Dr. Susan Carlson:        Yeah.

Dr. Kristina Harris:        So you have to look at baseline blood levels of these nutrients in order to get an accurate picture of status and how much these women need. This is why prenatal DHA testing is so important.

Dr. Susan Carlson:        Exactly. Exactly. And I think that’s a concern with a lot of nutrition trials, because as you begin to study a nutrient, it will have an impact on people’s behavior. And we can’t forget that there is an industry out there who listens more closely than physicians.

Dr. Susan Carlson:        I mean, they’re on top of any new thing that’s coming out because that affects their bottom line. I mean, there’s no evidence that 200 milligrams is good for pregnancy. It just, we said, “Okay, let’s, let’s make that the number.” Right? And that was one of the reasons we did the trial, frankly.

Dr. Bill Harris:                Yeah.

Dr. Susan Carlson:        Now there is evidence.

Dr. Bill Harris:                The 200 milligram story, I mean, so you still recommend 200 because it’s a good idea … without solid evidence-base.

Dr. Susan Carlson:        Yeah. Well, I mean, it’s better than zero. That would be the next trial that one would do is find women who are low and then do the trial with a placebo or 200 or 1000.

Dr. Bill Harris:                Yeah.

Dr. Susan Carlson:        You could design the trial.

Dr. Bill Harris:                Are there other big trials going on right now? Do you know?

Dr. Susan Carlson:        Are there, I’m not aware of any but I’m not sure that I would be actually, I haven’t looked on NIH lately. I haven’t looked to see what other trials might be funded out there around this question.

Dr. Bill Harris:                Okay.

Dr. Susan Carlson:        But as you know, the Cochrane review that came out in 2018 said we don’t need to do any more trials.

Dr. Bill Harris:                That’s right. That’s right.

Dr. Bill Harris:                Quite a statement.

Dr. Susan Carlson:        Yeah. That’s what it says, but unfortunately, it didn’t really tell women  how much DHA they needed to take. Right?

Dr. Kristina Harris:        Right.

Dr. Bill Harris:                I understand the dose used in those 70 trials in the Cochrane review was something in the neighborhood of 1500-1600 milligrams a day.

Dr. Susan Carlson:        I don’t think that’s true. I think they did a secondary analysis, if you would call it that, from the Cochrane results and came up with the idea that it’s probably over 500 milligrams before you get an effect on preterm birth.

Dr. Bill Harris:                Yeah. I missed that part.

Dr. Susan Carlson:        Because they included all kinds of randomized trials in there from low dose to  high dose omega-3 DHA.

Dr. Bill Harris:                Right.

Dr. Kristina Harris:        It was a big study. So this does lead a little bit into the other thing we wanted to talk about and that is blood levels and standardization.

Dr. Susan Carlson:        Yeah.

Dr. Susan Carlson:        I don’t know anything officially that would allow me to say why we got different results from women who started with higher baseline DHA.

Dr. Susan Carlson:        As you know, there is a paper saying that there is a relative risk of getting a high dose if you start with a high baseline DHA status.

Dr. Susan Carlson:        All I can say is that we’ve published this paper, and we addressed that issue for our study.

Dr. Susan Carlson:        And we had in our highest quartile of baseline DHA status, we had one early preterm birth out of 262 women, which is somewhere around 0.4%, I think.

Dr. Susan Carlson:        So in our trial, we don’t see that happening. Now, what we do see is if we look at that highest quartile, it’s kind of a flat, somewhere around 1.5%.

Dr. Susan Carlson:        We see kind of a flat amount of early preterm birth across every quartile in the high group, where it drops from 4.5% down to like, basically we didn’t have any really preterm verse in the highest quartile of 200 milligrams.

Dr. Susan Carlson:        I think that we do agree on one thing — and that is that women with low DHA status have a lower early preterm birth rate when you give them a high dose of omega-3 DHA.

Dr. Susan Carlson:        The other part we would have to resolve is that I would not feel any compunction to not give 1000 milligrams to women regardless of their baseline status. Because as I said before, we reduce preterm birth.

Dr. Kristina Harris:        When I was talking to people doing their work in Zimbabwe, where of course, where people don’t even have a good source of DHA that they can afford, it’s probably very safe in those conditions to give everybody a high dose. And it would probably be wise and probably get a better result.

Dr. Susan Carlson:        For people who are very cautious, then they should test their blood DHA levels, which I think is what you’re leading into here.

Dr. Kristina Harris:        Everything is becoming more personalized instead of giving blanket recommendations. Your study just showed that depending on your blood level, your personal situation, it did affect what you kind of dose was needed, which I think makes sense. And so, especially in like the US and Australia and,  countries that have more like healthcare-based pregnancies, the omega-3 story is very similar to folic acid supplementation in that it’s generally recommended, but,  again, we have this dose issue.

So what if we were able to test pregnant women for Omega-3 status at their 12 week visit, and then be able to give a higher or a lower recommendation for Omega-3s potentially.

Dr. Susan Carlson:        Yeah. I agree with that.

Dr. Bill Harris:                Where do you think obstetricians are in this?

Dr. Susan Carlson:        I’ve been thinking about this because there’s 4 million deliveries give or take in the US every year. And, and our friends in South Australia are getting the blood from everybody in South Australia and analyzing it and making recommendations based on that.

Dr. Susan Carlson:        I guess I’m a little more pragmatic. I would like to find a better way. So one of the things we did was we asked women using a 7-question survey about foods that have DHA. And what we found is that women at baseline, who were taking less than 100 milligrams, they had a much lower early preterm birth rate if they got the 1000 milligram dose.

Dr. Susan Carlson:        So based on that, that could be a pragmatic approach. So we went to the OBs in our unit here, and they decided to administer a REDCap survey that has those seven questions. And of course the one thing we didn’t know was whether women could fill it out on their own reliably. So we’re just finishing that experiment, but we have 90 women who filled it out. The agreed to have my  research associate interview them the way she did during the study. Right? Because the question is, can they fill it out on their own?

And what I can say is that I’ve seen maybe the first 75, and there were two women who were outliers. One of them was low on the thing, and she was high when she interviewed her and turned out that when she took the questionnaire, she thought, “Oh my gosh, I should be taking DHA.” And then she went out and bought the supplement. So I think it’s going to be predicting almost perfectly, who is below 100 milligrams, which would then…

Dr. Kristina Harris:        Yeah.

Dr. Susan Carlson:        So we’re about to do another small trial that’s in discussion with DSM to do a compliance study where we actually get blood too. Because as you know, there’s not a complete correlation between blood DHA levels and the intake level.

Dr. Susan Carlson:        And so I think a low intake probably represents a low blood for the most part, but there are probably some women who are low intake, who have more DHA. I don’t know. I mean, we don’t know that, or there’d be a perfect correlation if that were the case.

Dr. Bill Harris:                Right.

Dr. Susan Carlson:        So we’d like to have both the questionnaire and blood. What, what we’re going to do is if women have a low intake, then we’re going to randomize them, and we’re going to get blood and send it up to you guys and get the blood spot analysis too, to see how that goes.

Dr. Kristina Harris:        For the pregnancy story, there is, it seems like it’s more of a threshold effect at a lower Omega-3 status than we usually talk about for, you know, optimum health for adults in general. And when you’re getting up to the higher statuses, people will say, “Oh, I take a supplement or I eat fish occasionally.” And then they think they have optimal, they’re in 8% of Omega-3 index. And we know that almost always is not the case.

Dr. Susan Carlson:        Yeah.

Dr. Kristina Harris:        But when you’re talking about pregnancy, the levels we’re talking about are much lower than what we’re talking about for the optimum which on our Prenatal DHA Test scale is more like 5%. It kind of matches your 6%, or 4% or 5%. And so when someone does take a low dose of Omega-3 supplement, or just like a normal supplement would be 300 EPA and DHA, that might be enough to get them above that threshold. That’s more a, maybe a deficiency kind of status situation then.

Dr. Bill Harris:                Yeah.

Dr. Susan Carlson:        Yeah.

Dr. Bill Harris:                But there’s, there’s, there’s optimal [00:33:00] for preventing preterm birth or reducing risk for preterm birth. And then there’s way more outcomes in a, in a pregnancy than just that. Right.

Dr. Kristina Harris:        Right.

Dr. Susan Carlson:        Right. There’s a lot of interest in the cardiovascular health of pregnant women and strategies, and you know, a higher dose may well be better in that particular case.

Dr. Bill Harris:                Right. Yeah. Well, even some of your other outcomes, you said there were benefits 1000 milligrams on some, some baby-based, infant-based outcomes um.

Dr. Susan Carlson:        Yes. That’s true. In our last trial, I think I may have mentioned this to you that we had a placebo or 600 milligrams. The boys whose mothers got 600 milligrams have a completely different inhibitory response. The girls, it didn’t matter if their mothers got it or not.

Dr. Susan Carlson:        But there was a sexual dimorphism on benefits. So the boys benefited from getting it, whereas the girls fine without it.

Dr. Susan Carlson:        Your mind goes to things like boys and, you know, hyperactivity and ADHD.

Dr. Bill Harris:                Sure. Yeah, yeah. Right. Yeah.

Dr. Susan Carlson:        So it was really on an inhibition, really their ability to how their brain is seeing things and how they’re reacting.

Dr. Bill Harris:                Interesting.

Dr. Susan Carlson:        They were all cognitively normal.

Dr. Susan Carlson:        But their brains function differently.

Dr. Bill Harris:                Yeah. This is deep stuff, deep stuff.

Dr. Susan Carlson:        Yeah.

Dr. Kristina Harris:        We’re probably running out of time and we’ve really covered a lot here. I’m sure we’ll talk again. We’re hopefully going to be working with a, a group in this field to look at harmonizing Omega-3 levels.

We want to have a standard level that would identify a low intake or a low Omega-3 status.

But I think what’s happening is really kind of pushing this forward. And then your study coming out also is saying if this is going to be used clinically, then we should at least standardize the blood measurements. So we can tell the clinical clinicians how to do this. So,  hopefully that’ll be something we can update a little bit later. Anything else that you want to say about the study and about what’s coming up next?

Dr. Susan Carlson:        I would just add to what you said there, that I have a colleague who’s doing studies in this area who did not realize until about a month ago that when you look at the DHA level in Olson study or another study, it’s not the same.

Dr. Kristina Harris:        Hmm.

Dr. Susan Carlson:        So people are doing these studies and they read a number and they don’t say, well, “Oh, it was plasma or it was red blood cell.” They just look at the number. Actually, one of the reviewers of this paper had read Olson’s paper on plasma and said, “Well they’re 4%. So why are you using 6%?” Well, then I had to explain that plasma has very low levels of these fats, you know, the DHA compared to a red blood cell phospholipid first, so it’s confusing. And it’s not practical for an obstetrician. So I do think that we need some harmonization. We need to get it out there with a little table that everybody can go to and refer to quickly.

Dr. Kristina Harris:        And we look forward to having a more coordinated effort to make sure we report like the same things as much as we can.

Dr. Susan Carlson:        Yeah. The one thing that I would say is that I’ve been encouraged by obstetricians responses to this data that are picking it up. And the obstetricians — there were four on this study — and they were kind of blown away by this because they really don’t have any way to fix the issue of preterm birth.

Dr. Susan Carlson:        You can predict who’s going to have an early preterm birth, but they don’t have any solid strategies to prevent it. And this trial was interestingly done, where women had had a prior preterm birth before 34 weeks actually got all the treatment that is recommended by ACOG (American College of Obstetrics and Gynecology). So it’s a real world trial, and we still reduced it from 4% to 2%.

Dr. Bill Harris:                So where are you getting champions among the obstetricians that, you know, who would maybe push this kind of thing at ACOG?

Dr. Susan Carlson:        Well, at this point, I’m kind of waiting to get this paper out that Sarah is doing with the REDCap survey. That could be implemented anywhere.

Dr. Susan Carlson:        And you know, one of the obstetricians here just embraced it instantly. And he actually wrote the REDCap survey. So I’m encouraged, but I don’t want to push it too far because I think it, you know, what I asked the obstetricians on the trial to do was, “Put this up on your Facebook, your LinkedIn,” because they’re not going to listen to me but they will listen to their peers. Right?

Dr. Bill Harris:                Right, right.

Dr. Susan Carlson:        If their peers are getting excited about it, I think we’re good.

Dr. Bill Harris:                That’s good. It’s exciting.

Dr. Susan Carlson:        For the future, I think we’re going to need your prenatal DHA test. You’re going to have to figure out a scale up.

Dr. Kristina Harris:        Okay. We’ll do that.

Dr. Susan Carlson:        Are you ready for that?

Dr. Kristina Harris:        Yes. We’d love it. Well, thank you so much, Susan for talking with us about your paper and the great work that you’re doing. And we hope we get to talk to you again soon.

These statements have not been evaluated by the Food and Drug Administration. This test is not intended to diagnose, treat, cure, prevent or mitigate any disease. This site does not offer medical advice, and nothing contained herein is intended to establish a doctor/patient relationship. OmegaQuant, LLC is regulated under the Clinical Laboratory improvement Amendments of 1988 (CLIA) and is qualified to perform high complexity clinical testing. The performance characteristics of this test were determined by OmegaQuant, LLC. It has not been cleared or approved by the U.S. Food and Drug Administration.