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N-3 Fatty Acid Requirements for Human Development

NCT00620672 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2016-06-01

No results posted yet for this study

Summary

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.

Conditions

  • Pregnancy

Interventions

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

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Sheila M. Innis, Ph.D · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2011-12-31
Completion
2016-05-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00620672 on ClinicalTrials.gov