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Assessment of DHA On Reducing Early Preterm Birth

NCT02626299 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1100

Last updated 2021-03-30

No results posted yet for this study

Summary

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).

Conditions

Interventions

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)

DRUG

Docosahexaenoic acid - 200mg/day

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

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.

Sponsors & Collaborators

  • University of Cincinnati

    collaborator OTHER

  • Ohio State University

    collaborator OTHER

  • Nationwide Children's Hospital

    collaborator OTHER

  • University of Kansas Medical Center

    lead OTHER

Principal Investigators

  • Susan E. Carlson, PhD · University of Kansas Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-08
Primary Completion
2020-10-05
Completion
2020-10-05

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02626299 on ClinicalTrials.gov