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

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

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.

Study Overview

• Status: Completed
• Conditions: Severe Acute Malnutrition
• Intervention / Treatment: Dietary supplement: Standard RUTF; Dietary supplement: RUTF/Flax Oil; Dietary supplement: RUTF/Flax Oil plus additional Fish Oil

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Kenya
  • Coast
    • Kilifi, Coast, Kenya, 80108
      • Kilifi District Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard RUTF; Standard RUTF given according to National Guidelines	Dietary supplement: Standard RUTF; Standard formulation RUTF given according to National Guidelines
Experimental: RUTF/Flax Oil; RUTF/Flax Oil is reformulated RUTF to increase n3 content	Dietary supplement: RUTF/Flax Oil; Ready to Use Therapeutic Food
Experimental: 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	Dietary supplement: RUTF/Flax Oil plus additional Fish Oil; Ready to Use Therapeutic Food

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Oxford
• Collaborators: KEMRI-Wellcome Trust Collaborative Research Program
• Investigators: Principal Investigator: James A Berkley, FRCPCH, KEMRI-Wellcome Trust Collaborative Research Program

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: May 4, 2012
• First Submitted That Met QC Criteria: May 7, 2012
• First Posted (Estimate): May 8, 2012

Study Record Updates

• Last Update Posted (Estimate): August 18, 2014
• Last Update Submitted That Met QC Criteria: August 15, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Fish oil; Essential Fatty Acid; Seed oil; Dietary deficiency
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Severe Acute Malnutrition
• Other Study ID Numbers: SSC 2157; OPP1046183 (Other Grant/Funding Number: The Bill & Melinda Gates Foundation)