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DHA Supplementation and Pregnancy Outcome

This study has been completed.
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Susan Carlson, PhD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00266825
First received: December 15, 2005
Last updated: February 11, 2016
Last verified: February 2016
  Purpose
The purpose of the study is to determine if increasing DHA intake during pregnancy can increase gestation duration and enhance infant and childhood outcomes related to visual acuity, stereoacuity, attention, and distractibility.

Condition Intervention Phase
Pregnancy
Drug: DHA
Other: Placebo capsule
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Kansas University DHA Outcome Study (KUDOS)

Further study details as provided by University of Kansas Medical Center:

Primary Outcome Measures:
  • Percentage of Total Fatty Acids by Weight [ Time Frame: at time of birth ] [ Designated as safety issue: No ]
    Measure of RBC-phospholipid-DHA at Birth

  • Gestational Age [ Time Frame: at time of birth ] [ Designated as safety issue: No ]
    Gestational age of babies at time of birth in days

  • Birth Weight [ Time Frame: at time of birth ] [ Designated as safety issue: No ]
    Weight of baby at birth

  • Birth Length [ Time Frame: at time of birth ] [ Designated as safety issue: No ]
    Length of baby at birth


Secondary Outcome Measures:
  • Ponderal Index [ Time Frame: at time of birth ] [ Designated as safety issue: No ]
    Ponderal index calculated with formula Weight (g)/length (cm)^3 * 100. It a measure of leanness of a person and is calculated as a relationship between mass and height. Commonly used in pediatrics.

  • Gender of Babies [ Time Frame: at time of birth ] [ Designated as safety issue: No ]
  • Cord RBC-phospholipid-DHA [ Time Frame: at time of birth ] [ Designated as safety issue: No ]
    Percentage of total fatty acids by weight in cord RBC

  • Head Circumference [ Time Frame: at time of birth ] [ Designated as safety issue: No ]
    Measure of circumference of baby's head in centimeters at time of birth.

  • Preterm Births [ Time Frame: births before week 37 of gestation ] [ Designated as safety issue: No ]
    Percentage of births occurring at less than 37 weeks of gestation.


Enrollment: 350
Study Start Date: January 2006
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DHA capsules
DHA capsules
Drug: DHA
600 mg DHA
Other Name: docosahexaenoic acid
Placebo Comparator: Placebo capsules
Placebo capsule
Other: Placebo capsule
Placebo capsule

Detailed Description:
Although numerous trials show benefits of postnatal DHA supplementation for visual acuity and others show benefits for cognitive function and/or attention, studies of increased DHA exposure during fetal life are needed, especially in the US. Women in the US consume low amounts of DHA compared to other world populations, and this likely means less DHA transfer to the fetus than in many other populations. Prenatal DHA exposure may be more important than postnatal exposure, because animal studies show critical windows for brain DHA accumulation in relation to effects on neurotransmitters such as serotonin, dopamine and GABA.
  Eligibility

Ages Eligible for Study:   16 Years to 36 Years   (Child, Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant 8-20 wks at enrollment
  • single fetus
  • BMI <40

Exclusion Criteria:

  • diabetes (Type I, ii, GDM)
  • hypertension (primary, PIH, preeclampsia/eclampsia)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00266825

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Missouri
Truman Medical Center
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Susan Carlson, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Susan E Carlson, PhD University of Kansas Medical Center
Principal Investigator: John Colombo, PhD University of Kansas
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Susan Carlson, PhD, Professor, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00266825     History of Changes
Other Study ID Numbers: 10186  R01HD047315 
Study First Received: December 15, 2005
Results First Received: June 30, 2015
Last Updated: February 11, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Undecided

ClinicalTrials.gov processed this record on September 28, 2016