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DHA Supplementation and Pregnancy Outcome

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ClinicalTrials.gov Identifier: NCT02219399
Recruitment Status : Completed
First Posted : August 18, 2014
Last Update Posted : August 18, 2014
Sponsor:
Collaborator:
USDA Beltsville Human Nutrition Research Center
Information provided by (Responsible Party):
Colorado State University

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

Condition or disease Intervention/treatment Phase
Pregnancy Dietary Supplement: 600 mg DHA Dietary Supplement: 300 mg DHA Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 871 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Maternal DHA Supplementation and Pregnancy Outcome
Study Start Date : January 2001
Actual Primary Completion Date : January 2004
Actual Study Completion Date : January 2014

Arm Intervention/treatment
Experimental: 300 mg DHA
300 mg DHA
Dietary Supplement: 300 mg DHA
Pregnant women were given 300 mg DHA in the last trimester of pregnancy and through the first 3 months of breastfeeding

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

Experimental: 600 mg DHA
600 mg DHA
Dietary Supplement: 600 mg DHA
Pregnant women were given 600 mg DHA in the last trimester of pregnancy




Primary Outcome Measures :
  1. Gestational Length [ Time Frame: 13 weeks ]
    Length of gestation as measured by Last menstrual period method and US

  2. Cognitive Development [ Time Frame: 4 months ]
    Bayley's Scales of Infant Development measured at 4 months of age

  3. Cognitive Development [ Time Frame: 12 months ]
    Bayley's Scales of Infant Development measured at 12 months of age


Secondary Outcome Measures :
  1. Infant birth length [ Time Frame: 13 weeks ]
    self-explanatory

  2. Infant Growth Velocity [ Time Frame: 2 months to 4 months of age ]
    Change in infant length and weight from 2 to 4 months of age

  3. Infant birth weight [ Time Frame: 13 weeks ]
    self-explanatory

  4. Infant head circumference at birth [ Time Frame: 13 weeks ]
    self-explanatory



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • singleton pregnancy
  • 18 years of age or older

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02219399


Locations
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United States, Colorado
Denver Health Hospitals and Clinics
Denver, Colorado, United States, 80237
Colorado State University
Fort Collins, Colorado, United States, 80523
Sponsors and Collaborators
Colorado State University
USDA Beltsville Human Nutrition Research Center
Investigators
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Principal Investigator: Mary A Harris, PhD Colorado State University
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Responsible Party: Colorado State University
ClinicalTrials.gov Identifier: NCT02219399    
Other Study ID Numbers: 00186H
First Posted: August 18, 2014    Key Record Dates
Last Update Posted: August 18, 2014
Last Verified: August 2014
Keywords provided by Colorado State University:
Pregnancy
DHA
Gestational Length
Cognitive Development