DHA Supplementation for Pregnancy and Child Development

(NAPS Trial)

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Chicago

Must not be taking: Steroids, Blood thinners, Psychotropics

Disqualifiers: Medical complications, Alcohol, Cigarettes, others

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 25

Duration: 28-31 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether taking a daily DHA supplement (Docosahexaenoic acid, an Omega-3 fatty acid) during pregnancy can improve the health of both the mother and her baby. Researchers aim to determine if the supplement leads to better birth outcomes and enhanced brain development in babies. They also seek to understand if reducing maternal stress during pregnancy contributes to these benefits. Pregnant women with low fish intake (less than two servings a week) and who receive public assistance might be suitable candidates for this study. Participants will receive either the DHA supplement or a placebo from early pregnancy until birth. As an unphased trial, this study provides a unique opportunity to contribute to understanding the potential benefits of DHA during pregnancy.

Do I need to stop my current medications for the trial?

Yes, you will need to stop taking certain medications, such as steroid medications, blood thinners, and psychotropic medications, to participate in the trial.

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

Research shows that DHA, a type of omega-3 fatty acid, is generally safe during pregnancy. Studies indicate that DHA plays a crucial role in the baby's brain and eye development. One study found that taking 450-800 mg of DHA daily can reduce the risk of early birth and support healthy birth weight.

DHA supplements have been linked to fewer cases of premature birth. However, some research presents mixed results regarding DHA's effectiveness in preventing pregnancy issues. DHA is already a common supplement for pregnant women, suggesting it is well-tolerated. Always consult a healthcare provider before starting any new supplement. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard prenatal vitamins, which often focus on a broad mix of nutrients, this treatment emphasizes DHA, a specific omega-3 fatty acid. Researchers are excited because DHA is crucial for brain and eye development in babies, and this trial explores its potential benefits when supplemented at a higher dose than typically found in standard prenatal care. This targeted approach could offer enhanced developmental support during pregnancy, providing a simple yet potentially impactful boost to traditional prenatal health routines.

What evidence suggests that DHA supplementation might be an effective treatment for pregnancy and child development?

Research has shown that DHA, a type of omega-3 fatty acid, is important for a baby's brain development during pregnancy. In this trial, some participants will receive DHA supplements. Studies have found that these supplements can lower the chance of early births and help babies be born at a healthier weight. Specifically, babies whose mothers took DHA during pregnancy demonstrated better health at birth and handled stress better. However, the effects of DHA on pregnancy complications remain unclear. Overall, DHA appears to offer several benefits for both the mother and baby during pregnancy. ^{1 2 4 6 7}

Who Is on the Research Team?

Kathryn Keenan, Ph.D

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for pregnant women aged 18-34 who are on public assistance due to low income and consume less than two fish servings per week, indicating low levels of DHA.

Inclusion Criteria

Household recipient of public assistance (e.g. Medicaid insurance) due to low income

Low levels of DHA consumption as defined as less than two fish servings per week

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 450 mg/daily of DHA or placebo from 9-12 weeks of gestation through the end of pregnancy

28-31 weeks

Visits at baseline, 24, 30, and 36 weeks of pregnancy

Follow-up

Participants are monitored for infant neurodevelopmental outcomes and stress reactivity at 1, 4, and 9 months after birth

9 months

Visits at 1, 4, and 9 months after birth

What Are the Treatments Tested in This Trial?

Interventions

• DHA
• Sugar pill

Trial Overview The study is testing if taking DHA supplements during pregnancy can improve mothers' health, infant birth weight, and brain development. It also looks at whether these benefits are linked to reduced stress in the mother.

How Is the Trial Designed?

Group I: Oral supplement for pregnant women Experimental Treatment 1 Intervention

450 mg/daily of DHA beginning at 10-16 weeks of gestation through the end of pregnancy

Group II: Sugar pill Placebo Group 1 Intervention

450 mg/daily of sugar pill beginning at 10-16 weeks of gestation through the end of pregnancy

DHA is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as DHA for:

• Pregnancy and lactation support
• Cardiovascular health
• Infant nutrition

Approved in European Union as DHA for:

• Pregnancy and lactation support
• Cardiovascular health
• Infant nutrition
• Cognitive function

Approved in Canada as DHA for:

• Pregnancy and lactation support
• Cardiovascular health
• Infant nutrition

Approved in Japan as DHA for:

• Infant nutrition
• Cardiovascular health

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

University of Pittsburgh

Collaborator

Trials

1,820

Recruited

16,360,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Citations

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

Omega-3 Fatty Acids and Pregnancy - PMC The preponderance of data suggests that omega-3 fatty acid intake during pregnancy is important for fetal brain development and the child's subsequent ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0271531724000873

A Systematic Review and Meta-Analysis of the Association ... The outcomes of this meta-analysis show that prenatal DHA supplementation may reduce the risk of preterm births and increase infant birth weight. Significant ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4955755/

The effect of prenatal docosahexaenoic acid supplementation ... Infants of women living in urban, low-income environments who received DHA supplementation had more optimal birth outcomes and more modulated cortisol response ...

4. translational-medicine.biomedcentral.com translational-medicine.biomedcentral.com/articles/10.1186/s12967-023-04239-8

DHA supplementation and pregnancy complications Our results suggest that there is limited and controversial evidence for the protective effect of DHA intake on pregnancy complications, with ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2475299124017050

The Effect of Prenatal Docosahexaenoic Acid ... Greater prenatal DHA supplementation was associated with greater offspring FM and adipose tissue distribution at 24 mo.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4564584/

The Effect of Omega-3 Docosahexaenoic Acid ... The rate of early preterm birth (1.7%) in those supplemented with DHA (combined 300 and 600 mg/day) was significantly lower than in controls. Conclusion.

7. ajogmfm.org ajogmfm.org/article/S2589-9333(23)00393-2/fulltext

Omega-3 fatty acid supply in pregnancy for risk reduction ... Pregnant women with a low docosahexaenoic acid intake and/or low docosahexaenoic acid blood levels have an increased risk of preterm birth and ...