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

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ClinicalTrials.gov Identifier: NCT01593969
Recruitment Status : Completed
First Posted : May 8, 2012
Last Update Posted : August 18, 2014
Sponsor:
Collaborator:
KEMRI-Wellcome Trust Collaborative Research Program
Information provided by (Responsible Party):
University of Oxford

Tracking Information
First Submitted Date  ICMJE May 4, 2012
First Posted Date  ICMJE May 8, 2012
Last Update Posted Date August 18, 2014
Study Start Date  ICMJE May 2012
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2012)
Total long chain PUFA in erythrocyte membranes at 3 months [ Time Frame: 3 months ]
Total long chain PUFA in erythrocyte membranes at 3 months
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01593969 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2012)
  • Ratio of n-6:n-3 PUFA in erythrocyte membranes at 3 months [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 3 months ]
    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 ]
    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 ]
    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 ]
    Change in mid upper arm circumference between baseline and 3 months
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial of n-3 PUFA-Enriched Ready to Use Therapeutic Food for Childhood Severe Malnutrition
Official Title  ICMJE A Randomised Controlled Trial of n-3 Polyunsaturated Fatty Acid-Enriched Therapeutic Food for Childhood Severe Malnutrition
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Severe Acute Malnutrition
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 7, 2012)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Kenya
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01593969
Other Study ID Numbers  ICMJE SSC 2157
OPP1046183 ( Other Grant/Funding Number: The Bill & Melinda Gates Foundation )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Oxford
Study Sponsor  ICMJE University of Oxford
Collaborators  ICMJE KEMRI-Wellcome Trust Collaborative Research Program
Investigators  ICMJE
Principal Investigator: James A Berkley, FRCPCH KEMRI-Wellcome Trust Collaborative Research Program
PRS Account University of Oxford
Verification Date August 2014

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