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N-3 Fatty Acid Requirements for Human Development

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ClinicalTrials.gov Identifier: NCT00620672
Recruitment Status : Completed
First Posted : February 21, 2008
Last Update Posted : June 1, 2016
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of British Columbia

February 11, 2008
February 21, 2008
June 1, 2016
May 2004
December 2011   (Final data collection date for primary outcome measure)
Primary outcome is measuring of infant CNS maturity to 18 months of age [ Time Frame: 18 months ]
Primary outcome is measuring of infant CNS maturity to 18 months of age
Primary outcome is measuring of infant CNS maturity at 2 months of age, and mental developmental indices at 9 months. [ Time Frame: 9 months ]
Complete list of historical versions of study NCT00620672 on ClinicalTrials.gov Archive Site
Length of gestation and infant birth weight, infant growth (weight, length and head circumference) at 1,2 6,9,12,14,and 18 months Language development at 14 and 16 months [ Time Frame: 72 months ]
  • Length of gestation and infant birth weight, infant growth (weight, length and head circumference) at 1,2 6,9,12,14,and 18 months
  • Diet, blood an dbreast milk fatty acids
Length of gestation and infant birth weight, infant growth (weight, length and head circumference) at 1,2 6,9,12,14,and 18 months Language development at 14 and 16 months Cognitive, mental and motor development at 18 months [ Time Frame: 18 months ]
Not Provided
Not Provided
 
N-3 Fatty Acid Requirements for Human Development
To Compare Measures of Central Nervous System Maturity of Visual Acuity, Language, Mental and Motor Skill Development in Term Infants Following Maternal Supplementation Wit the n-3 Fatty Acid Docosahexaenoic Acid (DHA) During Gestation.
Polyunsaturated fatty acids known as n-3 fatty acids are essential dietary nutrients for humans, and are known to be important to reducing the risk of certain diseases, particularly those related to neural system, cardiovascular system and immune system. Among the different n-3 fatty acids, docosahexaenoic acid (DHA) is present in particularly high amounts in the brain and retina, and is accumulated in large amounts in these organs during the last trimester of fetal development and first few months after birth. The n-3 fatty acids are present in the diet as linolenic acid which is found in vegetable and seed oils, and as DHA which is only found in animal tissue fats, with fatty fish being the richest dietary source. Humans are able to convert linolenic acid to DHA, but the conversion is believed to be slow in human and possibly inadequate to support the needs for DHA for the developing brain. Information from our work and those of others has suggested that DHA is important during pregnancy, however specific evidence is lacking to show that the DHA status of pregnant women in low, or that improvement in the DHA status of Canadian women during pregnancy will have benefit to early infant an child development. There is no evidence that infants of vegans and vegetarians, or women who do not eat DHA are at risk for developmental delays. The purpose of this study is to investigate whether a dietary supplement of DHA during pregnancy has any effect on infant birth weight, or indices of infant growth, visual, mental and motor skill development.
This is a randomized, blinded prospective study with 2 groups: placebo and group supplemented with DHA. Women are randomized at 16 weeks gestation without knowledge of their dietary fatty acid intake. Only healthy women expecting to deliver a single infant with no known or anticipated maternal or fetal complications are enrolled. Maternal venous blood is collected at 16 and 36 weeks of gestation and used to assess the maternal DHA status and effect of DHA supplementation. Dietary information is collected at 16 and 36 weeks of gestation to determine usual fatty acid intakes. Following delivery, fetal cord blood is collected to assess transfer of DHA from mother to fetus. Breast milk samples are collected from all breast feeding mothers at 1 and 2 months postpartum. The mother -infant pairs are followed for 18 months. Measures include visual acuity, language, motor and mental development, and growth and dietary intakes.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Pregnancy
  • Dietary Supplement: omega 3 fatty acids
    The supplements are taken orally with a meal, each day. The amount of the omega 3 fatty acid docosahexaenoic acid is 400 mg/day; taken in two 500 mg capsules each providing 200 mg docosahexaenoic acid. The placebo is two 500 mg capsules soybean/canola oil. Both the supplement and placebo are a total of 1 gm/day (2x500 mg) and about 10 calories per day.
  • Dietary Supplement: vegetable oil
    The supplement is a dietary supplement of vegetable oil as a placebo
  • 1
    The dietary supplement is 400 mg/day of the omega 3 fatty acid docosahexaenoic acid . The docosahexaenoic acid is provided in triglycerides from Martek Biosciences, Maryland. The supplement is a blend of soybean and canola oil, blended to resemble the usual fat composition of the diet. Both the supplement and placebo provide a total of about 10 calories per day to the diet.
    Intervention: Dietary Supplement: omega 3 fatty acids
  • 2
    Dietary supplement is vegetable oil, the placebo.
    Intervention: Dietary Supplement: vegetable oil

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
270
400
May 2016
December 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 12-16 weeks gestation
  • Low risk pregnancy
  • Expected to deliver single full term
  • No maternal metabolic or infectious disease
  • No known fetal complications.
Sexes Eligible for Study: Female
20 Years to 40 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00620672
H03-70242
CW03-0084
No
Not Provided
Not Provided
University of British Columbia
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Sheila M. Innis, Ph.D University of British Columbia
University of British Columbia
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP