NCT02219399

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
871

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
Completed

Started Jan 2001

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

2 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

Study Start

First participant enrolled

January 1, 2001

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2004

Completed
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 18, 2014

Completed
Last Updated

August 18, 2014

Status Verified

August 1, 2014

Enrollment Period

3 years

First QC Date

June 9, 2014

Last Update Submit

August 15, 2014

Conditions

Pregnancy

Keywords

PregnancyDHAGestational LengthCognitive Development

Outcome Measures

Primary Outcomes (3)

  • Gestational Length

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

    13 weeks

  • Cognitive Development

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

    4 months

  • Cognitive Development

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

    12 months

Secondary Outcomes (4)

  • Infant birth length

    13 weeks

  • Infant Growth Velocity

    2 months to 4 months of age

  • Infant birth weight

    13 weeks

  • Infant head circumference at birth

    13 weeks

Study Arms (3)

300 mg DHA

EXPERIMENTAL

300 mg DHA

Dietary Supplement: 300 mg DHA

Placebo

PLACEBO COMPARATOR

olive oil or high oleic acid sunflower oil placebo

Dietary Supplement: Placebo

600 mg DHA

EXPERIMENTAL

600 mg DHA

Dietary Supplement: 600 mg DHA

Interventions

600 mg DHADIETARY_SUPPLEMENT

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

600 mg DHA
300 mg DHADIETARY_SUPPLEMENT

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

300 mg DHA
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • singleton pregnancy
  • years of age or older

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Denver Health Hospitals and Clinics

Denver, Colorado, 80237, United States

Location

Colorado State University

Fort Collins, Colorado, 80523, United States

Location

Study Officials

  • Mary A Harris, PhD

    Colorado State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2014

First Posted

August 18, 2014

Study Start

January 1, 2001

Primary Completion

January 1, 2004

Study Completion

January 1, 2014

Last Updated

August 18, 2014

Record last verified: 2014-08

Locations

US(2)