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

University of Oxford60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Severe Acute Malnutrition

Interventions

RUTF/Flax OilDIETARY_SUPPLEMENT

Ready to Use Therapeutic Food

RUTF/Flax Oil plus additional Fish OilDIETARY_SUPPLEMENT

Ready to Use Therapeutic Food

Standard RUTFDIETARY_SUPPLEMENT

Standard formulation RUTF given according to National Guidelines

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 5 Years

Medical Language ↔ Plain English

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.

Locations (1)

Kilifi District Hospital

Kilifi, Coast, Kenya

Outcomes

Primary Outcomes

Total long chain PUFA in erythrocyte membranes at 3 months

Time frame: 3 months

Secondary Outcomes

Ratio of n-6:n-3 PUFA in erythrocyte membranes at 3 months

Time frame: 3 months

Total long chain 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

Time frame: 3 months

Total long chain PUFA in plasma at 3 months

Time frame: 3 months

Ratio of n-6:n-3 PUFA in plasma at 3 months

Time frame: 3 months

Change in weight for height z score between baseline and 3 months

Time frame: 3 months

Change in mid upper arm circumference between baseline and 3 months

Time frame: 3 months

Data from ClinicalTrials.gov

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