A Trial of n-3 PUFA-Enriched Ready to Use Therapeutic Food for Childhood Severe Malnutrition

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomised Controlled Trial of n-3 Polyunsaturated Fatty Acid-Enriched Therapeutic Food for Childhood Severe Malnutrition

Conditions
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Severe Acute Malnutrition

Intervention / Treatment
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* Dietary Supplement: RUTF/Flax Oil
* Dietary Supplement: RUTF/Flax Oil plus additional Fish Oil
* Dietary Supplement: Standard RUTF


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard RUTF<br>Standard RUTF given according to National Guidelines | Dietary Supplement: Standard RUTF<br>* Standard formulation RUTF given according to National Guidelines<br>|
| Experimental: RUTF/Flax Oil<br>RUTF/Flax Oil is reformulated RUTF to increase n3 content | Dietary Supplement: RUTF/Flax Oil<br>* Ready to Use Therapeutic Food<br>|
| Experimental: RUTF/Flax Oil plus additional Fish Oil<br>RUTF/Flax Oil plus additional Fish Oil is RUTF reformulated to increase n3. Fish oil to provide long chain n3 | Dietary Supplement: RUTF/Flax Oil plus additional Fish Oil<br>* Ready to Use Therapeutic Food<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total long chain PUFA in erythrocyte membranes at 3 months | Total long chain PUFA in erythrocyte membranes at 3 months | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of n-6:n-3 PUFA in erythrocyte membranes at 3 months | Ratio of n-6:n-3 PUFA in erythrocyte membranes at 3 months | 3 months | 
| Total long chain PUFA in CD3 cell membranes at 3 months | Total long chain PUFA in CD3 cell membranes at 3 months | 3 months | 
| Ratio of n-6:n-3 PUFA in CD3 cell membranes at 3 months | Ratio of n-6:n-3 PUFA in CD3 cell membranes at 3 months | 3 months | 
| Total long chain PUFA in plasma at 3 months | Total long chain PUFA in plasma at 3 months | 3 months | 
| Ratio of n-6:n-3 PUFA in plasma at 3 months | Ratio of n-6:n-3 PUFA in plasma at 3 months | 3 months | 
| Change in weight for height z score between baseline and 3 months | Change in weight for height z score between baseline and 3 months | 3 months | 
| Change in mid upper arm circumference between baseline and 3 months | Change in mid upper arm circumference between baseline and 3 months | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Essential Fatty Acid, Seed oil, Fish oil, Dietary deficiency