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

This study is currently recruiting participants.
Verified April 2013 by University of Oxford
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: April 9, 2013
Last verified: April 2013
History of Changes

May 4, 2012
April 9, 2013
May 2012
August 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01593969 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
A Trial of n-3 PUFA-Enriched Ready to Use Therapeutic Food for Childhood Severe Malnutrition
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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Severe Acute Malnutrition
  • Dietary Supplement: RUTF/Flax Oil
    Ready to Use Therapeutic Food
  • Dietary Supplement: RUTF/Flax Oil plus additional Fish Oil
    Ready to Use Therapeutic Food
  • Dietary Supplement: Standard RUTF
    Standard formulation RUTF given according to National Guidelines
  • Active Comparator: Standard RUTF
    Standard RUTF given according to National Guidelines
    Intervention: Dietary Supplement: Standard RUTF
  • Experimental: RUTF/Flax Oil
    RUTF/Flax Oil is reformulated RUTF to increase n3 content
    Intervention: Dietary Supplement: RUTF/Flax Oil
  • 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
    Intervention: Dietary Supplement: RUTF/Flax Oil plus additional Fish Oil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
November 2013
August 2013   (final data collection date for primary outcome measure)

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.
Both
6 Months to 5 Years
No
Contact: James A Berkley, FRCPCH +254 417 522063 jberkley@kemri-wellcome.org
Contact: Kelsey J Jones, MRCPCH +254 417 522063 kjones@kemri-wellcome.org
Kenya
 
NCT01593969
SSC 2157, OPP1046183
No
University of Oxford
University of Oxford
KEMRI-Wellcome Trust Collaborative Research Program
Principal Investigator: James A Berkley, FRCPCH KEMRI-Wellcome Trust Collaborative Research Program
University of Oxford
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP