Clinical trial NCT01593969: A Trial of n-3 PUFA-Enriched Ready to Use Therapeutic Food for Childhood Severe Malnutrition
Official title: A Randomised Controlled Trial of n-3 Polyunsaturated Fatty Acid-Enriched Therapeutic Food for Childhood Severe Malnutrition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Severe Acute Malnutrition
Keywords: Essential Fatty Acid
Seed oil
Fish oil
Dietary deficiency
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: KEMRI-Wellcome Trust Collaborative Research Program
First posted: 2012-05-08
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total long chain PUFA in erythrocyte membranes at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Ratio of n-6:n-3 PUFA in erythrocyte membranes at 3 months
timeFrame: 3 months
measure: Total long chain PUFA in CD3 cell membranes at 3 months
timeFrame: 3 months
measure: Ratio of n-6:n-3 PUFA in CD3 cell membranes at 3 months
timeFrame: 3 months
measure: Total long chain PUFA in plasma at 3 months
timeFrame: 3 months
measure: Ratio of n-6:n-3 PUFA in plasma at 3 months
timeFrame: 3 months
measure: Change in weight for height z score between baseline and 3 months
timeFrame: 3 months
measure: Change in mid upper arm circumference between baseline and 3 months
timeFrame: 3 months
Other outcomes:
Locations:
city: Kilifi
country: Kenya
facility: Kilifi District Hospital
state: Coast
Study officials:
affiliation: KEMRI-Wellcome Trust Collaborative Research Program
name: James A Berkley, FRCPCH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jones KD, Ali R, Khasira MA, Odera D, West AL, Koster G, Akomo P, Talbert AW, Goss VM, Ngari M, Thitiri J, Ndoro S, Knight MA, Omollo K, Ndungu A, Mulongo MM, Bahwere P, Fegan G, Warner JO, Postle AD, Collins S, Calder PC, Berkley JA. Ready-to-use therapeutic food with elevated n-3 polyunsaturated fatty acid content, with or without fish oil, to treat severe acute malnutrition: a randomized controlled trial. BMC Med. 2015 Apr 23;13:93. doi: 10.1186/s12916-015-0315-6.