A Trial of n-3 PUFA-Enriched Ready to Use Therapeutic Food for Childhood Severe Malnutrition
- Conditions
- Severe Acute Malnutrition
- Interventions
- Dietary Supplement: Standard RUTFDietary Supplement: RUTF/Flax OilDietary Supplement: RUTF/Flax Oil plus additional Fish Oil
- Registration Number
- NCT01593969
- Lead Sponsor
- University of Oxford
- 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 Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Children aged 6 months to 5 years old
- Provision of informed consent
- Severe malnutrition (one or more of mid-upper arm circumference <11.5cm, weight for height z score <-3, or nutritional oedema)
- Stabilised and eligible to receive RUTF according to national guidelines
-
Known HIV disease, tuberculosis or other chronic infection*
-
Known allergy or hypersensitivity to any of the product ingredients
- Chronic infections such as HIV and tuberculosis and their treatments are likely to cause alterations in lipid metabolism that may confound interpretation of this pilot trial. national guidelines recommend offering provider-initiated testing for HIV for all severely malnourished children, and referral for comprehensive care in the case of a positive test.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard RUTF Standard RUTF Standard RUTF given according to National Guidelines RUTF/Flax Oil RUTF/Flax Oil RUTF/Flax Oil is reformulated RUTF to increase n3 content RUTF/Flax Oil plus additional Fish Oil RUTF/Flax Oil plus additional Fish Oil RUTF/Flax Oil plus additional Fish Oil is RUTF reformulated to increase n3. Fish oil to provide long chain n3
- Primary Outcome Measures
Name Time Method Total long chain PUFA in erythrocyte membranes at 3 months 3 months Total long chain PUFA in erythrocyte membranes at 3 months
- Secondary Outcome Measures
Name Time Method Change in weight for height z score between baseline and 3 months 3 months Change in weight for height z score between baseline and 3 months
Ratio of n-6:n-3 PUFA in erythrocyte membranes at 3 months 3 months Ratio of n-6:n-3 PUFA in erythrocyte membranes at 3 months
Total long chain PUFA in plasma at 3 months 3 months Total long chain PUFA in plasma at 3 months
Change in mid upper arm circumference between baseline and 3 months 3 months Change in mid upper arm circumference between baseline and 3 months
Ratio of n-6:n-3 PUFA in CD3 cell membranes at 3 months 3 months Ratio of n-6:n-3 PUFA in CD3 cell membranes at 3 months
Total long chain PUFA in CD3 cell membranes at 3 months 3 months Total long chain PUFA in CD3 cell membranes at 3 months
Ratio of n-6:n-3 PUFA in plasma at 3 months 3 months Ratio of n-6:n-3 PUFA in plasma at 3 months
Trial Locations
- Locations (1)
Kilifi District Hospital
🇰🇪Kilifi, Coast, Kenya