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

Severe Acute Malnutrition Clinical Trial

— Njugu Plus  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01593969
• Other study ID #: SSC 2157
• Secondary ID: OPP1046183
• Status: Completed
• Phase: Phase 2
• First received: May 4, 2012
• Last updated: August 15, 2014
• Start date: May 2012
• Est. completion date: June 2014

Study information

• Verified date: August 2014
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Oxford Tropical Research Ethics Committee (OXTREC)Kenya: Ethical Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 5 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malnutrition
• Severe Acute Malnutrition

Intervention

Dietary Supplement:
• RUTF/Flax Oil
Ready to Use Therapeutic Food
• RUTF/Flax Oil plus additional Fish Oil
Ready to Use Therapeutic Food
• Standard RUTF
Standard formulation RUTF given according to National Guidelines

Locations

Country	Name	City	State
Kenya	Kilifi District Hospital	Kilifi	Coast

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	KEMRI-Wellcome Trust Collaborative Research Program

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total long chain PUFA in erythrocyte membranes at 3 months	Total long chain PUFA in erythrocyte membranes at 3 months	3 months	No
Secondary	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	No
Secondary	Total long chain PUFA in CD3 cell membranes at 3 months	Total long chain PUFA in CD3 cell membranes at 3 months	3 months	No
Secondary	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	No
Secondary	Total long chain PUFA in plasma at 3 months	Total long chain PUFA in plasma at 3 months	3 months	No
Secondary	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	No
Secondary	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	No
Secondary	Change in mid upper arm circumference between baseline and 3 months	Change in mid upper arm circumference between baseline and 3 months	3 months	No