Omega 3 Supplementation for Pregnancy

(TOTS Trial)

Recruiting at 1 trial location

Overseen By Teri L Hernandez, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Diabetes, Preeclampsia, Hypertension, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 34 weeks gestational age

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether an omega-3 supplement can help manage triglyceride levels in pregnant women. Triglycerides, fats in the blood, can rise during pregnancy and may lead to larger babies if levels become too high. The trial includes two groups: one taking omega-3 supplements and the other taking a safflower oil placebo. Pregnant women with a pre-pregnancy BMI between 28 and 39 and triglyceride levels of 120 mg/dL or higher by the 15th week of pregnancy might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to understanding the potential benefits of omega-3 supplements for pregnant women.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that omega-3 fatty acids can be beneficial during pregnancy. Some studies suggest they might reduce the risk of early birth and support the baby's growth, including increasing birth weight and head size. However, the full effects of omega-3 supplements during pregnancy remain unclear.

Animal studies have demonstrated that very high doses of omega-3s could harm developing babies, but these doses far exceed the usual recommendations for humans. For people, omega-3 supplements are generally safe when taken at recommended levels. It is important to consult a healthcare provider before starting any new supplement, especially during pregnancy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike other supplements for pregnancy, Omega 3 supplementation offers a unique benefit by providing high doses of DHA and EPA, essential fatty acids crucial for fetal brain development. While many prenatal vitamins contain limited amounts of Omega 3s, this treatment delivers a potent 4g daily dose, potentially enhancing maternal and fetal health more effectively. Researchers are excited because these Omega 3s may also reduce inflammation and improve pregnancy outcomes, offering a promising alternative to standard prenatal supplements.

What evidence suggests that omega-3 supplementation could be effective for managing triglyceride levels in pregnancy?

This trial will compare Omega-3 supplementation with a placebo, Safflower Oil Supplement. Studies have shown that omega-3 supplements can significantly lower blood fat levels during pregnancy. High fat levels can lead to larger babies, potentially causing complications. Research indicates that taking omega-3s while pregnant helps manage these fat levels without harming pregnancy outcomes. Omega-3s also support the baby's brain growth and overall development, enhancing their benefits. Evidence shows that this supplement can effectively help manage blood fat levels during pregnancy. ^{6 7 8 9 10}

Who Is on the Research Team?

Teri L Hernandez, PhD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for pregnant women aged 21-39 with a pre-pregnancy BMI of 28-39 and fasting triglyceride levels ≥120 mg/dL measured by week 15. It excludes those on chronic steroids, using tobacco or illicit substances, or with histories of certain pregnancy complications like pre-eclampsia or diabetes.

Inclusion Criteria

Fasting Triglyceride ≥120 mg/dL measured by 15 wks

Pregnant women between the ages of 21-39 yrs

Pre-pregnancy BMI 28-39

Exclusion Criteria

You have been taking steroids for a long time.

You use tobacco or illegal drugs.

You had high blood pressure or gave birth prematurely before 34 weeks during pregnancy due to pre-eclampsia or gestational hypertension.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either omega-3 fatty acid supplementation or safflower oil placebo to assess effects on triglyceride levels during pregnancy

Up to 34 weeks gestational age

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Intervention Omega 3 Supplementation

Trial Overview The study is testing if omega-3 fatty acid supplements can control the rise in blood fat (triglycerides) during the third trimester of pregnancy compared to safflower oil. High triglycerides are linked to having larger babies.

How Is the Trial Designed?

Group I: Omega 3 Supplementation Experimental Treatment 1 Intervention

Supplementation of 4g of DHA/EPA daily

Group II: Safflower Oil Supplement Placebo Group 1 Intervention

Supplementation of Safflower Oil daily

Intervention Omega 3 Supplementation is already approved in United States for the following indications:

Approved in United States as Lovaza for:

• Severe hypertriglyceridemia (HTG)

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

University of Oklahoma

Collaborator

Trials

484

Recruited

95,900+

Published Research Related to This Trial

Low-dose fish oil supplements during pregnancy can significantly improve the levels of long-chain polyunsaturated fatty acids (LCPomega3) in newborns, particularly when taken as a milk-based supplement or higher-dose fish oil capsules.

A daily intake of 500-1000 mg of LCPomega3 from these supplements effectively enhances fetal omega-3 status at term delivery, without negatively impacting omega-6 levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of three low-dose fish oil supplements, administered during pregnancy, on neonatal long-chain polyunsaturated fatty acid status at birth. Velzing-Aarts, FV., van der Klis, FR., van der Dijs, FP., et al.[2006]

Adequate intake of omega-3 fatty acids, particularly DHA and EPA, during pregnancy can lead to longer gestation periods and improved cognitive and visual performance in infants, while also potentially reducing the risk of preterm birth.

Many pregnant women in the U.S. consume insufficient omega-3 fatty acids due to dietary preferences, highlighting the need for prenatal care providers to encourage safe sources of omega-3s, such as purified fish oil, algal oil supplements, or DHA-enriched eggs, to meet the recommended intake of 200 to 300 mg daily.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prenatal omega-3 fatty acids: review and recommendations. Jordan, RG.[2010]

Omega-3 fatty acids are crucial during pregnancy for fetal brain and retina development, and they may help prevent perinatal depression and influence gestation length.

Despite their importance, many pregnant women do not consume enough omega-3 fatty acids due to concerns about mercury and contaminants in fish, highlighting the need for dietary guidance from healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omega-3 Fatty acids and pregnancy. Coletta, JM., Bell, SJ., Roman, AS.[2022]

Omega-3 fatty acid supplementation during pregnancy and postpartum has been associated with various benefits, including potential positive effects on gestation duration, infant size at birth, and maternal mental health, as indicated by 14 out of 26 studies reviewed.

Despite these potential benefits, there is no clear consensus on the optimal intake levels or specific effects of omega-3 fatty acids, highlighting the need for further research to establish guidelines for pregnant and lactating women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of supplementary omega-3 fatty acids on pregnant women with complications and pregnancy outcomes: review from literature. Chowdhury, MH., Ghosh, S., Kabir, MR., et al.[2022]

Omega-3 fatty acids are crucial for fetal brain development and may influence gestation timing and birth weight, highlighting their importance during pregnancy.

Most pregnant women do not meet the recommended intake of omega-3 fatty acids, which can be addressed by consuming a variety of sources, including low-mercury fish, vegetable oils, and supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omega-3 Fatty Acid supplementation during pregnancy. Greenberg, JA., Bell, SJ., Ausdal, WV.[2022]

Long-chain omega-3 polyunsaturated fatty acids (PUFAs) like eicosapentaenoic and docosahexaenoic acids are beneficial for health throughout life, influencing fetal development, pregnancy outcomes, and cognitive function in offspring.

These omega-3 supplements are considered safe and effective, potentially improving health outcomes such as reducing the risk of premature delivery and supporting neurodevelopmental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omega-3 Fatty Acids and Fecundation, Pregnancy and Breastfeeding. Politano, CA., López-Berroa, J.[2023]

Omega-3 polyunsaturated fatty acid (PUFA) supplementation during pregnancy significantly increases HDL-cholesterol levels and reduces C-reactive protein, indicating potential cardiovascular benefits.

However, the supplementation did not show significant effects on other metabolic parameters such as fasting plasma glucose, insulin levels, or inflammation markers, suggesting that its benefits may be limited to specific lipid profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of omega-3 fatty acids supplementation on metabolic status in pregnant women: a systematic review and meta-analysis of randomized controlled trials. Amirani, E., Asemi, Z., Asbaghi, O., et al.[2022]

In a study of 853 pregnant women in Iceland, it was found that higher consumption of fish and omega-3 supplements was associated with increased plasma levels of omega-3 fatty acids, indicating effective absorption and potential benefits for fetal development.

Despite recommendations for fish intake, only one third of the women consumed fish at least twice weekly, and the maternal multivitamin containing omega-3 did not correlate with plasma omega-3 levels, suggesting that dietary sources and specific supplements are more effective for increasing omega-3 levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Correlation between intake of fish or supplements containing omega-3 fatty acids and early pregnancy plasma concentrations.] Tryggvadottir, EA., Halldorsson, TI., Birgisdottir, BE., et al.[2022]

Omega-3 fatty acids play a crucial role in fetal and neonatal development, and their supplementation during pregnancy and lactation can enhance health outcomes for both mothers and infants.

Recent innovations in infant formula now include omega-3 fatty acid supplementation, which is beneficial for bottle-fed infants, while also addressing the challenges faced by vegan and vegetarian mothers in obtaining these essential nutrients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omega-3 fatty acid supplementation in perinatal settings. Blanchard, DS.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3046737/

Omega-3 Fatty Acids and Pregnancy - PMC Both have been shown to have multiple beneficial effects, including improving childhood development when ingested during pregnancy. Fetal brain growth ...

2. tandfonline.com tandfonline.com/doi/full/10.1080/14767058.2025.2536177

Effects of omega-3 fatty acids supplementation on lipids ... Conclusions. Omega-3 fatty acid supplementation during pregnancy significantly reduced TG and had no significant negative effect on pregnancy outcomes.

3. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2024.1439599/full

Impact of omega-3 fatty acids supplementation on lipid ... Based on GEE analysis results, omega-3 fatty acids supplementation significantly decreased TG levels during pregnancy, both before and after ...

4. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2009/021654s023lbl.pdf

2 LOVAZA® - accessdata.fda.gov Omega-3-acid ethyl esters have been shown to have an embryocidal effect in pregnant rats 163 when given in doses resulting in exposures 7 times the recommended ...

5. uptodate.com uptodate.com/contents/fish-consumption-and-marine-omega-3-fatty-acid-supplementation-in-pregnancy/print

Fish consumption and marine omega-3 fatty acid ... Biology and biologic effects – Marine omega-3 fatty acids have a variety of biologic effects, including specific effects related to pregnancy. DHA and EPA are ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2019/021654s043lbl.pdf

highlights of prescribing information - accessdata.fda.gov Omega-3-acid ethyl esters have been shown to have an embryocidal effect in pregnant rats when given in doses resulting in exposures 7 times the recommended ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2009/021654s022lbl.pdf

LOVAZA (omega-3-acid ethyl esters) Capsules 108 Animal Data: Omega-3-acid ethyl esters have been shown to have an embryocidal effect 109 in pregnant rats when given in doses resulting in exposures 7 ...

8. webmd.com webmd.com/drugs/2/drug-92326/omega-3-acid-ethyl-esters-oral/details

Omega-3-Acid Ethyl Esters (Lovaza, Omacor, Triklo) It is not known if or how omega-3-acid ethyl esters could affect pregnancy or harm a fetus. Tell your health care provider if you are pregnant ...

9. drugs.com drugs.com/pregnancy/omega-3-polyunsaturated-fatty-acids.html

Omega-3 polyunsaturated fatty acids Use During Pregnancy Adequate omega-3 fatty acid intake during pregnancy may reduce preterm birth, increase birth length, weight, and head circumference, improve cognitive and ...

10. ods.od.nih.gov ods.od.nih.gov/factsheets/Omega3FattyAcids-HealthProfessional/

Omega-3 Fatty Acids - Health Professional Fact Sheet Omega 3 fatty acids overview for health professionals. Research health effects, dosing, sources, deficiency, side effects, and interactions here.