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Purpose

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).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
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.
  • Drug: Docosahexaenoic acid - 200mg/day
    The control group will receive 1-capsule containing 200 mg DHA/d.
    Other names:
    • DHA
  • Other: 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.
Experimental
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.
  • Drug: 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)
    Other names:
    • DHA
  • Drug: Docosahexaenoic acid - 200mg/day
    The control group will receive 1-capsule containing 200 mg DHA/d.
    Other names:
    • DHA

More Details

Status
Completed
Sponsor
University of Kansas Medical Center

Study Contact

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.