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CompletedNCT02219399Updated Aug 18, 2014

DHA Supplementation and Pregnancy Outcome

An interventional study of 600 mg DHA and 300 mg DHA in Pregnancy, sponsored by Colorado State University. Completed at 2 sites in United States. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2014-08-18.

Sponsored by Colorado State University · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
871
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

Supplementation with DHA during pregnancy will increase gestational length and improve cognitive development.

Read the detailed description

This was a trial of supplementation with DHA during pregnancy to increase gestational length. Subjects were provided with 300 mg, 600 mg or placebo (olive oil) in a randomized design from week 24-26 of pregnancy until delivery. Gestational age, birth weight and birth length data were collected and infants growth at 2 and 4 months and cognitive development at 4 months and 1 year were measured.

02

Conditions studied

  • Pregnancy

Keywords

  • Pregnancy
  • DHA
  • Gestational Length
  • Cognitive Development
03

In context

Lead sponsor

Colorado State University is the lead sponsor of 112 studies on the registry; 19 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • singleton pregnancy
  • 18 years of age or older

Exclusion criteria

Exclusion Criteria:

  • cervical incompetence
  • presence of cervical cerclage
  • placenta previa
  • intrauterine infection
  • known substance abuse
  • multiple fetuses
  • current pre-eclampsia
  • preexisting diabetes
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
871 participants (actual)

Study arms

  • Experimental
    300 mg DHA

    300 mg DHA

    Dietary Supplement: 300 mg DHA

  • Placebo comparator
    Placebo

    olive oil or high oleic acid sunflower oil placebo

    Dietary Supplement: Placebo

  • Experimental
    600 mg DHA

    600 mg DHA

    Dietary Supplement: 600 mg DHA

Interventions

  • Dietary supplement600 mg DHA

    Pregnant women were given 600 mg DHA in the last trimester of pregnancy

  • Dietary supplement300 mg DHA

    Pregnant women were given 300 mg DHA in the last trimester of pregnancy and through the first 3 months of breastfeeding

  • Dietary supplementPlacebo

    Pregnant women in the control group received placebo of either olive oil or high oleic acid sunflower oil during the study period

06

What researchers measure

Primary outcomes

  1. Gestational Length

    Length of gestation as measured by Last menstrual period method and US

    Time frame: 13 weeks

  2. Cognitive Development

    Bayley's Scales of Infant Development measured at 4 months of age

    Time frame: 4 months

  3. Cognitive Development

    Bayley's Scales of Infant Development measured at 12 months of age

    Time frame: 12 months

Secondary outcomes

  1. Infant birth length

    self-explanatory

    Time frame: 13 weeks

  2. Infant Growth Velocity

    Change in infant length and weight from 2 to 4 months of age

    Time frame: 2 months to 4 months of age

  3. Infant birth weight

    self-explanatory

    Time frame: 13 weeks

  4. Infant head circumference at birth

    self-explanatory

    Time frame: 13 weeks

07

Study locations

2 sites
  • Denver Health Hospitals and Clinics
    Denver, Colorado 80237, United States
  • Colorado State University
    Fort Collins, Colorado 80523, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02219399
Lead sponsor
Colorado State University
Collaborators
USDA Beltsville Human Nutrition Research Center
Responsible party
Sponsor
First posted
Aug 18, 2014
Start date
Jan 2001
Primary completion
Jan 2004
Completion
Jan 2014
Last update
Aug 18, 2014

Study contacts

Mary A Harris, PhD
principal investigator · Colorado State University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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