NCT02626299

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,100

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2016

Typical duration for phase_3

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 10, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

June 8, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2020

Completed
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

4.3 years

First QC Date

December 8, 2015

Last Update Submit

March 25, 2021

Conditions

Preterm Birth

Keywords

Preterm birthEarly preterm birthVery low birth weightLow birth weightPregnancy outcomeDocosahexaenoic acid (DHA)Randomized cliinical trialSuperiority trialAdaptive design

Outcome Measures

Primary Outcomes (3)

  • Occurrence of Early Preterm Birth (<34 weeks gestation)

    Bayesian posterior mean and 95% credible interval of pregnancies which result in an early preterm birth (birth before 34 weeks of pregnancy) by DHA dose

    Baseline to 34 Weeks

  • Occurrence of Early Preterm Birth (<34 weeks gestation)

    Bayesian posterior mean and 95% credible interval of pregnancies which result in an early preterm birth (birth before 34 weeks of pregnancy) by DHA dose and DHA status at enrollment (low/high) (modified statistical analysis plan while study was underway)

    Baseline to 34 weeks

  • Maternal and infant adverse and serious adverse events

    Bayesian posterior mean and 95% credible interval by dose

    Enrollment to 30 days past last birth

Secondary Outcomes (18)

  • Very low birth weight

    At birth

  • Low birth weight

    birth

  • Maternal and infant DHA status

    birth

  • Gestational age

    birth

  • Birth weight

    birth

  • +13 more secondary outcomes

Study Arms (2)

200 mg/day DHA

PLACEBO COMPARATOR

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/dayOther: Placebo

1000 mg/day DHA

EXPERIMENTAL

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/dayDrug: Docosahexaenoic acid - 200mg/day

Interventions

Docosahexaenoic acid - 800mg/dayDRUG

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)

Also known as: DHA
1000 mg/day DHA
Docosahexaenoic acid - 200mg/dayDRUG

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

Also known as: DHA
1000 mg/day DHA200 mg/day DHA
PlaceboOTHER

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.

200 mg/day DHA

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45220, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (5)

  • Wang Y, Gajewski BJ, Valentine CJ, Crawford SA, Brown AR, Mudaranthakam DP, Camargo JT, Carlson SE. DHA, nutrient intake, and maternal characteristics as predictors of pregnancy outcomes in a randomised clinical trial of DHA supplementation. Clin Nutr. 2023 Nov;42(11):2229-2240. doi: 10.1016/j.clnu.2023.09.005. Epub 2023 Sep 20.

    PMID: 37806075DERIVED

  • Carlson SE, Gajewski BJ, Valentine CJ, Sands SA, Brown AR, Kerling EH, Crawford SA, Buhimschi CS, Weiner CP, Cackovic M, DeFranco EA, Mudaranthakam DP, Rogers LK. Early and late preterm birth rates in participants adherent to randomly assigned high dose docosahexaenoic acid (DHA) supplementation in pregnancy. Clin Nutr. 2023 Feb;42(2):235-243. doi: 10.1016/j.clnu.2023.01.009. Epub 2023 Jan 11.

    PMID: 36680919DERIVED

  • Mudaranthakam DP, Brown A, Kerling E, Carlson SE, Valentine CJ, Gajewski B. The Successful Synchronized Orchestration of an Investigator-Initiated Multicenter Trial Using a Clinical Trial Management System and Team Approach: Design and Utility Study. JMIR Form Res. 2021 Dec 22;5(12):e30368. doi: 10.2196/30368.

    PMID: 34941552DERIVED

  • Carlson SE, Gajewski BJ, Valentine CJ, Kerling EH, Weiner CP, Cackovic M, Buhimschi CS, Rogers LK, Sands SA, Brown AR, Mudaranthakam DP, Crawford SA, DeFranco EA. Higher dose docosahexaenoic acid supplementation during pregnancy and early preterm birth: A randomised, double-blind, adaptive-design superiority trial. EClinicalMedicine. 2021 May 17;36:100905. doi: 10.1016/j.eclinm.2021.100905. eCollection 2021 Jun.

    PMID: 34308309DERIVED

  • Carlson SE, Gajewski BJ, Valentine CJ, Rogers LK, Weiner CP, DeFranco EA, Buhimschi CS. Assessment of DHA on reducing early preterm birth: the ADORE randomized controlled trial protocol. BMC Pregnancy Childbirth. 2017 Feb 13;17(1):62. doi: 10.1186/s12884-017-1244-5.

    PMID: 28193189DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Susan E. Carlson, PhD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Dietetics and Nutrition

Study Record Dates

First Submitted

December 8, 2015

First Posted

December 10, 2015

Study Start

June 8, 2016

Primary Completion

October 5, 2020

Study Completion

October 5, 2020

Last Updated

March 30, 2021

Record last verified: 2021-03

Locations

US(3)