Assessment of DHA On Reducing Early Preterm Birth

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-08

Study Completion Date

2020-10-05

Brief Summary

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The purpose of this study is to determine if giving a larger amount of DHA than currently included in some prenatal supplements can reduce early preterm birth (birth before 34 weeks of pregnancy).

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Detailed Description

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Docosahexaenoic acid (DHA) is a nutrient found in some fish and eggs and its intake in US diets is typically low. Because DHA is important for early brain development, it has recently been added to many prenatal supplements. The usual amount is around 200 mg/day. Participants in this study are guaranteed to receive at least 200 mg/day of DHA.

Almost 5 in 100 births in the US occur before 34 weeks of pregnancy. There is no way to predict which births will occur before 34 weeks. In an earlier study conducted at the University of Kansas Medical Center, women who received 600 mg DHA/day compared to no DHA had fewer births before 34 weeks of pregnancy with fewer complications of preterm birth.

This study is designed to compare standard care (200 mg/day of DHA) to a higher amount of DHA (1000 mg/day) to determine if the higher amount will reduce early preterm birth (birth before 34 weeks of pregnancy). Individual participation in this study is expected last about 5 months.

Conditions

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Preterm Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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200 mg/day DHA

Participants will receive 2 placebo pills/day that do not contain DHA. Like the experimental group, they will be given a supplement of Docosahexaenoic acid - 200mg/day , a common amount in prenatal vitamins.

Group Type PLACEBO_COMPARATOR

Docosahexaenoic acid - 200mg/day

Intervention Type DRUG

The control group will receive 1-capsule containing 200 mg DHA/d.

Placebo

Intervention Type OTHER

Participants will receive 2 capsules (masked) containing half soybean oil and half corn oil equaling 800 mg.The soybean and corn oil combination does not contain DHA.

1000 mg/day DHA

The intervention includes Docosahexaenoic acid - 800mg/day per day provided in two 400 mg capsules. The intervention group as well as the active comparator group will be given 1-200 mg/capsule per day of DHA that is a common amount in prenatal vitamins.

Group Type EXPERIMENTAL

Docosahexaenoic acid - 800mg/day

Intervention Type DRUG

All participants will take 1000 mg/DHA per day (1 capsule will be labeled with 200 mg; 2 capsules will be masked with 400 mg each)

Docosahexaenoic acid - 200mg/day

Intervention Type DRUG

The control group will receive 1-capsule containing 200 mg DHA/d.

Interventions

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Docosahexaenoic acid - 800mg/day

All participants will take 1000 mg/DHA per day (1 capsule will be labeled with 200 mg; 2 capsules will be masked with 400 mg each)

Intervention Type DRUG

Docosahexaenoic acid - 200mg/day

The control group will receive 1-capsule containing 200 mg DHA/d.

Intervention Type DRUG

Placebo

Participants will receive 2 capsules (masked) containing half soybean oil and half corn oil equaling 800 mg.The soybean and corn oil combination does not contain DHA.

Intervention Type OTHER

Other Intervention Names

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DHA DHA

Eligibility Criteria

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Inclusion Criteria

* Pregnant females 18 years and older 12 to 20 weeks gestation at study entry
* Agree to consume study capsules and a typical prenatal supplement of 200 mg DHA
* Available by telephone
* Able to speak and read in either English or Spanish language

Exclusion Criteria

* Expecting multiple infants
* Gestational age at baseline \<12 weeks or \>20 weeks
* Unable or unwilling to agree to consume capsules until delivery
* Unwilling to discontinue use of another prenatal supplement that contains greater than or equal to 200 mg DHA per day
* Women with allergy to any component of DHA product (including algae), soybean oil or corn oil

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes