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

Primary Purpose

Severe Acute Malnutrition

Status
Completed
Phase
Phase 2
Locations
Kenya
Study Type
Interventional
Intervention
RUTF/Flax Oil
RUTF/Flax Oil plus additional Fish Oil
Standard RUTF
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Acute Malnutrition focused on measuring Essential Fatty Acid, Seed oil, Fish oil, Dietary deficiency

Eligibility Criteria

6 Months - 5 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kilifi District Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Standard RUTF

RUTF/Flax Oil

RUTF/Flax Oil plus additional Fish Oil

Arm Description

Standard RUTF given according to National Guidelines

RUTF/Flax Oil is reformulated RUTF to increase n3 content

RUTF/Flax Oil plus additional Fish Oil is RUTF reformulated to increase n3. Fish oil to provide long chain n3

Outcomes

Primary Outcome Measures

Total long chain PUFA in erythrocyte membranes at 3 months
Total long chain PUFA in erythrocyte membranes at 3 months

Secondary Outcome Measures

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
Total long chain PUFA in CD3 cell membranes at 3 months
Total long chain PUFA in CD3 cell membranes at 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
Total long chain PUFA in plasma at 3 months
Total long chain PUFA in plasma at 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
Change in weight for height z score between baseline and 3 months
Change in weight for height z score between baseline and 3 months
Change in mid upper arm circumference between baseline and 3 months
Change in mid upper arm circumference between baseline and 3 months

Full Information

First Posted
May 4, 2012
Last Updated
August 15, 2014
Sponsor
University of Oxford
Collaborators
KEMRI-Wellcome Trust Collaborative Research Program
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1. Study Identification

Unique Protocol Identification Number
NCT01593969
Brief Title
A Trial of n-3 PUFA-Enriched Ready to Use Therapeutic Food for Childhood Severe Malnutrition
Acronym
Njugu Plus
Official Title
A Randomised Controlled Trial of n-3 Polyunsaturated Fatty Acid-Enriched Therapeutic Food for Childhood Severe Malnutrition
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
Collaborators
KEMRI-Wellcome Trust Collaborative Research Program

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Acute Malnutrition
Keywords
Essential Fatty Acid, Seed oil, Fish oil, Dietary deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard RUTF
Arm Type
Active Comparator
Arm Description
Standard RUTF given according to National Guidelines
Arm Title
RUTF/Flax Oil
Arm Type
Experimental
Arm Description
RUTF/Flax Oil is reformulated RUTF to increase n3 content
Arm Title
RUTF/Flax Oil plus additional Fish Oil
Arm Type
Experimental
Arm Description
RUTF/Flax Oil plus additional Fish Oil is RUTF reformulated to increase n3. Fish oil to provide long chain n3
Intervention Type
Dietary Supplement
Intervention Name(s)
RUTF/Flax Oil
Intervention Description
Ready to Use Therapeutic Food
Intervention Type
Dietary Supplement
Intervention Name(s)
RUTF/Flax Oil plus additional Fish Oil
Intervention Description
Ready to Use Therapeutic Food
Intervention Type
Dietary Supplement
Intervention Name(s)
Standard RUTF
Intervention Description
Standard formulation RUTF given according to National Guidelines
Primary Outcome Measure Information:
Title
Total long chain PUFA in erythrocyte membranes at 3 months
Description
Total long chain PUFA in erythrocyte membranes at 3 months
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Ratio of n-6:n-3 PUFA in erythrocyte membranes at 3 months
Description
Ratio of n-6:n-3 PUFA in erythrocyte membranes at 3 months
Time Frame
3 months
Title
Total long chain PUFA in CD3 cell membranes at 3 months
Description
Total long chain PUFA in CD3 cell membranes at 3 months
Time Frame
3 months
Title
Ratio of n-6:n-3 PUFA in CD3 cell membranes at 3 months
Description
Ratio of n-6:n-3 PUFA in CD3 cell membranes at 3 months
Time Frame
3 months
Title
Total long chain PUFA in plasma at 3 months
Description
Total long chain PUFA in plasma at 3 months
Time Frame
3 months
Title
Ratio of n-6:n-3 PUFA in plasma at 3 months
Description
Ratio of n-6:n-3 PUFA in plasma at 3 months
Time Frame
3 months
Title
Change in weight for height z score between baseline and 3 months
Description
Change in weight for height z score between baseline and 3 months
Time Frame
3 months
Title
Change in mid upper arm circumference between baseline and 3 months
Description
Change in mid upper arm circumference between baseline and 3 months
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James A Berkley, FRCPCH
Organizational Affiliation
KEMRI-Wellcome Trust Collaborative Research Program
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kilifi District Hospital
City
Kilifi
State/Province
Coast
ZIP/Postal Code
80108
Country
Kenya

12. IPD Sharing Statement

Citations:
PubMed Identifier
25902844
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.
Results Reference
derived

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

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