# Docosahexaenoic Acid (DHA) Supplementation in Pregnancy to Reduce Early Preterm Birth

> **NIH NIH R01** · UNIVERSITY OF KANSAS MEDICAL CENTER · 2020 · $587,889

## Abstract

   
DESCRIPTION (provided by applicant): DHA intake of US adults is low and conversion of α-linolenic acid (18:3n-3) to DHA (22:6n-3) is also low. As a result US women enter pregnancy with lower DHA status than other countries in the developed world suggesting a potential deficiency of an important nutrient that has been shown to reduce inflammation. The goal of this Phase III Clinical Trial (randomized, double-blind, and placebo-controlled) is to test the primary hypothesis that supplementing US women with 1000 mg of docosahexaenoic acid (DHA), 800 mg above the amount currently in many prenatal nutritional supplements (~200 mg) during the half of pregnancy can reduce early preterm birth (ePTB) (<34 wk. gestation). This was a favorable secondary outcomes of a US trial (RO1 HD047315, Clinical Trials.gov ID: NCT00266825) conducted at one of the proposed study sites on which the current proposal is modeled. Secondary outcomes include birth weight <1500g and pregnancy outcomes (preeclampsia, gestational diabetes, C-section delivery). We propose a Bayesian Adaptive Design with 90% power to detect the hypothesized outcomes with an estimated 938 subjects that allows the study to stop early if strong results (probability >0.995) are observed before the study is scheduled to end and places 60% of the participants on the better DHA dose. Conventional equal randomization with 90% power would require 1200 subjects, be longer, and place only 50% of the participants on the better DHA dose. The proposed study has the potential to determine if nutritional supplementation with DHA during pregnancy can reduce the incidence of ePTB, a serious public health problem with large societal and family costs. The randomization design has the potential to significantly expedite findings to the research community and clinical practice.

## Key facts

- **NIH application ID:** 9841734
- **Project number:** 5R01HD083292-05
- **Recipient organization:** UNIVERSITY OF KANSAS MEDICAL CENTER
- **Principal Investigator:** SUSAN E CARLSON
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $587,889
- **Award type:** 5
- **Project period:** 2016-01-19 → 2021-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9841734

## Citation

> US National Institutes of Health, RePORTER application 9841734, Docosahexaenoic Acid (DHA) Supplementation in Pregnancy to Reduce Early Preterm Birth (5R01HD083292-05). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9841734. Licensed CC0.

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