NCT01112904|Completed
Essential Fatty Acid (EFA) Nutrition 5-Year-Olds Follow-Up Study
n-3 Fatty Acids and Early Child Nutrition: 5-Year-Olds Follow-Up Study
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n-3 Fatty Acids and Early Child Nutrition: 5-Year-Olds Follow-Up Study
Sponsor study identifier
observational
98
1 country
1
Study Start
February 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2014
Actual (reported)Study Completion
November 2014
Actual (reported)Docosahexanoic acid (DHA) is concentrated in the human brain. Before birth, DHA is transferred across the placenta, but transfer depends on maternal DHA intake. After birth, DHA is provided by breast milk or the child's diet. This study addresses whether DHA intakes are adequate to support human brain development. In a previous study "N-3 Fatty Acid Requirements for Human Development" (C03-0242), pregnant women were randomly assigned to 400 mg/day DHA or placebo from 16 weeks of gestation until infant delivery. Blood DHA in gestation, and infant development to 18 months were assessed. This follow-up study will assess if maternal DHA in gestation has long-term influence on child development when assessed at 5 years and the impact of the child's own diet.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2014
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2010
Date type not reportedThis date has not been verified as actual or estimated.
April 27, 2010
Actual (reported)April 29, 2010
Actual (reported)November 2014
Actual (reported)November 2014
Actual (reported)maternal DHA status in gestation
red blood cell DHA biochemistries
16 & 36 weeks gestation
plasma lutein and Red blood cell DHA
5 years 8 months to 6 years
cognitive development with standardized developmental tests
5 years 8 months to 6 years
Mothers who participated in study (REB # C03-0242 and C\&W W03-0084) and who have already provided written consent for re-contact to participate with their 5 year old child will participate in this follow-up study
Child & Family Research Institute, Nutrition and Metabolism Research Program
Vancouver, British Columbia, V5Z4H4, Canada
Plasma and blood cells
Sheila M. Innis, Dr.
University of British Columbia
Tim Oberlander, MD
University of British Columbia
98 participants (actual enrollment reported by the registry).
First Submitted
April 27, 2010
First Posted
April 29, 2010
Study Start
February 2010
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
November 2014
Actual (reported)Study Completion
November 2014
Actual (reported)Last Updated
April 15, 2015
Record last verified: 2015-04
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Source: ClinicalTrials.gov.
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