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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Summary:

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.


Sponsor: University of Oxford

Current Primary Outcome: 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: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: University of Oxford

Dates:
Date Received: May 4, 2012
Date Started: May 2012
Date Completion:
Last Updated: August 15, 2014
Last Verified: August 2014