Clinical Trial: Soy-Ready to Use Therapeutic Food (RUTF) in Severely Malnourished Children

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Efficacy of Ready to Use Therapeutic Food Using Soy Protein Isolate in Under-5 Children With Severe Acute Malnutrition in Bangladesh

Brief Summary:

SAM defined by having weight-for-height (WH) less than - 3 Z score or bi-pedal nutritional edema is an important cause of death in children globally including Bangladesh. The death rate among children hospitalized for SAM is still high. Severe malnutrition in children can be successfully treated by using WHO guidelines with or without minor modification. Since the Community Based Therapeutic Care (CTC)/CMAM approach was developed, the use of RUTF for the treatment of children with SAM has gained ground, and huge amounts of RUTF are used particularly in African countries. RUTFs are an energy-dense lipid paste enriched with vitamins and minerals. The typical composition (ingredient % of weight) of RUTF is whole milk powder 30%; sugar 28%; vegetable oil 15.4%; peanut paste 25%; and mineral vitamin mix 1.6%. Although the CTC model promises treatment of SAM at a considerably lower cost than the previous inpatient model, the cost of RUTF is still considered a significant barrier to universal roll-out of SAM treatment and has made CTC implementation too expensive in many high-need countries.

The single most expensive raw ingredient in RUTF is milk powder, contributing around 50% of raw ingredient cost or between 30-35% of the total cost of the final product. Isolated soy protein has a cost per kg protein that normally is below that of skim or whole milk powder, and can thus reduce the total cost of RUTF. In addition, isolated soy protein (ISP) is a high quality, complete protein that meets the daily protein requirements of growing children and adults. ISP is a highly digestible protein [FAO/WHO, 1991] with an amino acid profile that has been shown to achieve a Protein Digestibility-Corrected Amino Acid Score (PDCAAS) of 1.00, comparable to milk and eggs, and has been shown to maintain nitrogen balance when fed as the sole protein source at minimum recommended intake levels.

Detailed Summary:
Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh

Current Primary Outcome: To compare the efficacy (rate of weight gain) [ Time Frame: 31 December 2014 (up to 3 years) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: International Centre for Diarrhoeal Disease Research, Bangladesh

Dates:
Date Received: June 12, 2012
Date Started: July 2012
Date Completion: December 2016
Last Updated: March 24, 2016
Last Verified: June 2012