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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by International Centre for Diarrhoeal Disease Research, Bangladesh
Sponsor:
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier:
NCT01634009
First received: June 12, 2012
Last updated: January 6, 2013
Last verified: June 2012
  Purpose

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.

To compare the efficacy (weight gain, rate of weight gain and change of lean body mass) of the standard RUTF and an RUTF made from ISP (Soy-RUTF) through a randomized double masked intervention trial 300 SAM children aged 6 to 59 months after completion of their stabilization phase from the Dhaka Hospital of icddr,b Bangladesh will be studied. They will randomly receive standard- or Soy-RUTF as take home and followed up (weekly until achieving -2 WHZ, and thereafter fortnightly until achieving -1 WHZ) at the nutrition follow up unit at the outpatient department of this Dhaka Hospital of icddr,b.


Condition Intervention Phase
Severe Acute Malnutrition
Severe Wasting
Community Based Nutritional Management
Dietary Supplement: Soy-based RUTF (in double blind design)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Official Title: Efficacy of Ready to Use Therapeutic Food Using Soy Protein Isolate in Under-5 Children With Severe Acute Malnutrition in Bangladesh

Resource links provided by NLM:


Further study details as provided by International Centre for Diarrhoeal Disease Research, Bangladesh:

Primary Outcome Measures:
  • To compare the efficacy (rate of weight gain) [ Time Frame: 31 December 2014 (up to 3 years) ] [ Designated as safety issue: No ]
    By 31st December 2014 we shall be able to complete the enrollment, data analyses and preliminary/draft report writting.


Estimated Enrollment: 300
Study Start Date: July 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard RUTF (control)
Children will receive standard RUTF in this arm and will be considered as control arm
Dietary Supplement: Soy-based RUTF (in double blind design)
Soy-based RUTF will be given in double blind manner
Other Name: Soy-based RUTF is the intervention
No Intervention: Standard RUTF
Will act as control

  Eligibility

Ages Eligible for Study:   6 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children (both boys and girls) with SAM defined by WH < -3 Z score of WHO standard,
  • completed acute (stabilization) phase management,
  • clinically well,
  • no edema and regaining appetite and aged 6 to 60 months will be included. - additional enrollment criteria will be as follows:

    • no signs of concurrent infection,
    • mothers/caregivers agreed to stay in their current address for next 4 months (for tracking the children)

Exclusion Criteria:

  • failure to obtain consent from parents or caretakers;
  • children without any fixed address;
  • children with tuberculosis or any congenital/acquired disorder affecting growth i.e. trisomy-21 or cerebral palsy;
  • children on an exclusion diet for the treatment of persistent diarrhea,
  • having history of soy, peanut or milk protein allergy.
  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: NCT01634009

Locations
Bangladesh
Icddr,B Recruiting
Dhaka, Bangladesh, 21212
Contact: Md Iqbal Hossain, MBBS, DCH, PhD    +88 02 9840523 ext 2351    ihossain@icddrb.org   
Principal Investigator: Md Iqbal Hossain, MBBS, PhD         
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Investigators
Principal Investigator: MD IQBAL HOSSAIN, DCH, PhD International Centre for Diarrhoeal Disease Research, Bangladesh
  More Information

No publications provided

Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT01634009     History of Changes
Other Study ID Numbers: PR-09038
Study First Received: June 12, 2012
Last Updated: January 6, 2013
Health Authority: Bangladesh: Ethical Review Committee

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Severe acute malnutrition
Ready to use therapeutic food
Soy protein
Community based management
Efficacy
Management of Children with SAM in Bangladesh

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on August 20, 2014