N-3 Fatty Acid Requirements for Human Development
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00620672|
Recruitment Status : Completed
First Posted : February 21, 2008
Last Update Posted : June 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy||Dietary Supplement: omega 3 fatty acids Dietary Supplement: vegetable oil||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||270 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||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.|
|Study Start Date :||May 2004|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||May 2016|
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.
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 is vegetable oil, the placebo.
Dietary Supplement: vegetable oil
The supplement is a dietary supplement of vegetable oil as a placebo
- 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
- 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
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): NCT00620672
|Canada, British Columbia|
|Children's & Women's Health Centre of British Columbia|
|Vancouver, British Columbia, Canada, V6H 3V4|
|Principal Investigator:||Sheila M. Innis, Ph.D||University of British Columbia|