Status:
COMPLETED
Development and Field Testing of Ready-to-use-therapeutic Foods Made of Local Ingredients in Bangladesh for SAM Children
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborating Sponsors:
UNICEF
Nutriset
Conditions:
Severe Acute Malnutrition in Childhood
Eligibility:
All Genders
6-59 years
Phase:
PHASE2
PHASE3
Brief Summary
Around 0.5 million under-five children are currently suffering from severe acute malnutrition (SAM) in Bangladesh and are at risk of death. Children with SAM and complications should be treated in a h...
Detailed Description
Childhood malnutrition continues to be a significant public health problem in the world, especially in Asia. Acute malnutrition and more so, severe acute malnutrition (SAM) among children below five y...
Eligibility Criteria
Inclusion
- Children aged 6 to 59 months (either sex)
- Suffering from Severe Acute Malnutrition (SAM) defined by WHZ \<-3 using WHO growth standards 2006 and/or having bipedal edema (nutritional), and/or MUAC \<11.5 cm
- Have completed acute (stabilization) phase management, are clinically well, and have an appetite
- Additional enrollment criteria will be: no signs of concurrent infection, mothers/caregivers agree to stay in their current address for at least the next three months (for ease of follow-up of the children)
- Informed written consent obtained from the parent or guardian.
Exclusion
- Failure to obtain Informed consent from parents or caretakers
- Children without any fixed address
- Children with tuberculosis (diagnosis based on WHO 2006 guidelines which have been incorporated in the national TB control guidelines of Bangladesh)
- 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 known history of soy, peanut or milk protein allergy.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
490 Patients enrolled
Trial Details
Trial ID
NCT01889329
Start Date
April 1 2013
End Date
December 1 2015
Last Update
February 11 2022
Active Locations (1)
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1
International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)
Dhaka, Bangladesh, 1212