Severe Acute Malnutrition
Conditions
Keywords
Essential Fatty Acid, Seed oil, Fish oil, Dietary deficiency
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.
Interventions
DIETARY_SUPPLEMENTRUTF/Flax Oil
Ready to Use Therapeutic Food
DIETARY_SUPPLEMENTRUTF/Flax Oil plus additional Fish Oil
Ready to Use Therapeutic Food
DIETARY_SUPPLEMENTStandard RUTF
Standard formulation RUTF given according to National Guidelines
Sponsors
KEMRI-Wellcome Trust Collaborative Research Program
University of Oxford
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 5 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total long chain PUFA in erythrocyte membranes at 3 months | 3 months | Total long chain PUFA in erythrocyte membranes at 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 plasma at 3 months | 3 months | Total long chain PUFA in plasma at 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 |
| 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 |
| 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 plasma at 3 months | 3 months | Ratio of n-6:n-3 PUFA in plasma at 3 months |
Countries
Kenya
Outcome results
None listed