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

This study has been completed.
Sponsor:
Collaborator:
KEMRI-Wellcome Trust Collaborative Research Program
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01593969
First received: May 4, 2012
Last updated: August 15, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Severe Acute Malnutrition
Dietary Supplement: RUTF/Flax Oil
Dietary Supplement: RUTF/Flax Oil plus additional Fish Oil
Dietary Supplement: Standard RUTF
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial of n-3 Polyunsaturated Fatty Acid-Enriched Therapeutic Food for Childhood Severe Malnutrition

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Total long chain PUFA in erythrocyte membranes at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Ratio of n-6:n-3 PUFA in erythrocyte membranes at 3 months

  • Total long chain PUFA in CD3 cell membranes at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Ratio of n-6:n-3 PUFA in CD3 cell membranes at 3 months

  • Total long chain PUFA in plasma at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Total long chain PUFA in plasma at 3 months

  • Ratio of n-6:n-3 PUFA in plasma at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Ratio of n-6:n-3 PUFA in plasma at 3 months

  • Change in weight for height z score between baseline and 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Change in weight for height z score between baseline and 3 months

  • Change in mid upper arm circumference between baseline and 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Change in mid upper arm circumference between baseline and 3 months


Enrollment: 60
Study Start Date: May 2012
Study Completion Date: June 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   6 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01593969

Locations
Kenya
Kilifi District Hospital
Kilifi, Coast, Kenya, 80108
Sponsors and Collaborators
University of Oxford
KEMRI-Wellcome Trust Collaborative Research Program
Investigators
Principal Investigator: James A Berkley, FRCPCH KEMRI-Wellcome Trust Collaborative Research Program
  More Information

No publications provided

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01593969     History of Changes
Other Study ID Numbers: SSC 2157, OPP1046183
Study First Received: May 4, 2012
Last Updated: August 15, 2014
Health Authority: United Kingdom: Oxford Tropical Research Ethics Committee (OXTREC)
Kenya: Ethical Review Committee

Keywords provided by University of Oxford:
Essential Fatty Acid
Seed oil
Fish oil
Dietary deficiency

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on August 26, 2014