Omega 3 Supplementation for Pregnancy

(TOTS Trial)

Recruiting at1 trial location

Overseen by Teri L Hernandez, PhD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Colorado, Denver

Disqualifiers: Diabetes, Preeclampsia, Hypertension, others

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial aims to see if taking an omega-3 fatty acid supplement can help pregnant women with high triglyceride levels. High triglycerides can lead to having larger babies. The supplement might help control these fat levels in the blood. Omega-3 fatty acids, particularly DHA and EPA, have been studied for their potential benefits during pregnancy, including reducing preterm birth and improving fetal growth.

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.

What evidence supports the effectiveness of the omega-3 supplementation treatment during pregnancy?

Research suggests that omega-3 fatty acids, which are important for fetal brain and eye development, may help reduce the risk of premature delivery and improve cognitive function in children. Studies have shown that taking omega-3 supplements during pregnancy can increase important fatty acid levels in the baby, which are crucial for healthy development. ^{1 2 3 4 5}

Is omega-3 supplementation safe during pregnancy?

Omega-3 fatty acids, found in fish oil and other supplements, are generally considered safe during pregnancy and are important for fetal brain and eye development. However, pregnant women should ensure they consume omega-3s from safe sources to avoid contaminants like mercury. ^{2 3 5 6 7}

How does Omega 3 supplementation differ from other treatments for pregnancy?

Omega 3 supplementation is unique because it provides essential fatty acids that are crucial for fetal brain and retina development, which are not typically addressed by other treatments. Unlike other options, it can be taken as a supplement to ensure adequate intake without the risk of mercury exposure from seafood, making it a safer choice for pregnant women. ^{2 3 5 8 9}

Research Team

Teri L Hernandez, PhD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Intervention Omega 3 Supplementation (Omega-3 Fatty Acid Supplement)

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.

Participant Groups

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

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Aviva Abosch

University of Colorado, Denver

Chief Medical Officer since 2019

MD

Uday B. Kompella

University of Colorado, Denver

Chief Executive Officer since 2015

PhD in Pharmaceutical Sciences

University of Oklahoma

Collaborator

Trials

484

Recruited

95,900+

Dr. Scott Rollins

University of Oklahoma

Chief Executive Officer since 2016

PhD in Immunology from the University of Oklahoma

Dr. Ondria Gleason

University of Oklahoma

Chief Medical Officer

MD from the University of Oklahoma College of Medicine

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

Omega-3 Fatty Acids and Fecundation, Pregnancy and Breastfeeding. [2023]

2. Scotland 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. [2006]

3. United States pubmed.ncbi.nlm.nih.gov

Omega-3 Fatty acids and pregnancy. [2022]

4. Switzerland 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. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Effect of supplementary omega-3 fatty acids on pregnant women with complications and pregnancy outcomes: review from literature. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. Iceland pubmed.ncbi.nlm.nih.gov

[Correlation between intake of fish or supplements containing omega-3 fatty acids and early pregnancy plasma concentrations.] [2022]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

Omega-3 Fatty Acid supplementation during pregnancy. [2022]