Clinical Trial: A Trial of n-3 PUFA-Enriched Ready to Use Therapeutic Food for Childhood Severe Malnutrition
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomised Controlled Trial of n-3 Polyunsaturated Fatty Acid-Enriched Therapeutic Food for Childhood Severe Malnutrition
Brief Summary: The investigators will perform a randomised controlled trial of the provision of food designed for rehabilitation of malnourished children that is supplemented with n-3 fatty acids compared to usual composition. The investigators want to see whether the provision of such a food normalises the deficiencies in essential fatty acids observed in severely malnourished children faster than standard composition.
Detailed Summary:
Randomized controlled trial of n-3 Polyunsaturated Fatty Acid-Enriched Therapeutic Food for Severe Malnutrition.
Description of Study Design: Randomized Controlled Trial
Study Duration: 6 months (Trial); 12 months (All trial-related activities)
Description of Intervention: Provision of ready to use food (RUTF) enriched with flax seed oil, with or without fish oil, compared to conventional-composition RUTF. Interventional product will be given until nutritional recovery to a maximum of 12 weeks.
Design: Flax-enriched or standard RUTF allocation is randomised and double blind. Fish oil allocation is randomised within those receiving flax-enriched RUTF and is open label.
Location: Kilifi District, coastal Kenya.
Sponsor: University of Oxford
Current Primary Outcome: Total long chain PUFA in erythrocyte membranes at 3 months [ Time Frame: 3 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Ratio of n-6:n-3 PUFA in erythrocyte membranes at 3 months [ Time Frame: 3 months ]Ratio of n-6:n-3 PUFA in erythrocyte membranes at 3 months
- Total long chain PUFA in CD3 cell membranes at 3 months [ Time Frame: 3 months ]Total long chain PUFA in CD3 cell membranes at 3 months
- Ratio of n-6:n-3 PUFA in CD3 cell membranes at 3 months [ Time Frame: 3 months ]Ratio of n-6:n-3 PUFA in CD3 cell membranes at 3 months
- Total long chain PUFA in plasma at 3 months [ Time Frame: 3 months ]Total long chain PUFA in plasma at 3 months
- Ratio of n-6:n-3 PUFA in plasma at 3 months [ Time Frame: 3 months ]Ratio of n-6:n-3 PUFA in plasma at 3 months
- Change in weight for height z score between baseline and 3 months [ Time Frame: 3 months ]Change in weight for height z score between baseline and 3 months
- Change in mid upper arm circumference between baseline and 3 months [ Time Frame: 3 months ]Change in mid upper arm circumference between baseline and 3 months
Original Secondary Outcome: Same as current
Information By: University of Oxford
Dates:
Date Received: May 4, 2012
Date Started: May 2012
Date Completion:
Last Updated: August 15, 2014
Last Verified: August 2014