Development and Field Testing of Ready-to-use-therapeutic Foods Made of Local Ingredients in Bangladesh for SAM Children

NCT01889329 | Completed Phase 2

• 1 other identifier: PR-11005
• Study Type: interventional
• Target: 490
• Locations: 1 country
• Sites: 1

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 health care facility. It is imperative, however, to manage children with SAM but without any complications in the community. This requires a ready-to-use-therapeutic food (RUTF) that conforms to standard recommendations on its composition. The prototype RUTF is peanut based, made outside Bangladesh, and has to be imported. By developing a RUTF using local food ingredients, test it for acceptability and efficacy in the treatment of children with SAM, hopefully make the treatment of SAM cost-effective and sustainable. Hypothesis: Does the locally developed ready-to-use-therapeutic foods (RUTFs) demonstrate similar or better acceptability and efficacy in the treatment of children suffering from severe acute malnutrition (SAM) when compared to the prototype RUTF (Plumpynut)?

Conditions

Severe Acute Malnutrition in Childhood

Outcome Measures

Primary Outcomes (1)

• Weight gain (g/kg/d)

  The primary objective of the proposed study will be to develop ready-to-use therapeutic food (RUTF) that will ultimately be used to treat childhood severe acute malnutrition which continues to be highly prevalent in Bangladesh. This will involve selection of candidate recipes of RUTF and testing them for acceptability and efficacy among children and caregivers. The successful candidate recipe of local RUTF is expected to have better weight gain (g/kg/d) in children suffering from Severe Acute Malnutrition (SAM).

  Initially 3 months for the acceptability trial another 18 months will be required for the efficacy trial

Study Arms (3)

RUTF-1

EXPERIMENTAL

Made from local food ingredients

Dietary Supplement: RUTF-1

RUTF-2

EXPERIMENTAL

Made from local food ingredients

Dietary Supplement: RUTF-2

Plumpynut

ACTIVE COMPARATOR

Made from peanut

Dietary Supplement: Plumpynut

Interventions

RUTF-1 DIETARY_SUPPLEMENT

Made from local food ingredients

RUTF-1

RUTF-2 DIETARY_SUPPLEMENT

Made from local food ingredients

RUTF-2

Plumpynut DIETARY_SUPPLEMENT

Commercially made from peanut paste

Plumpynut

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Having known history of soy, peanut or milk protein allergy.

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• UNICEF: collaborator
• Nutriset: collaborator

Study Sites (1)

International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)

Dhaka, 1212, Bangladesh

Location

Related Publications (1)

• Weagley JS, Zaydman M, Venkatesh S, Sasaki Y, Damaraju N, Yenkin A, Buchser W, Rodionov DA, Osterman A, Ahmed T, Barratt MJ, DiAntonio A, Milbrandt J, Gordon JI. Products of gut microbial Toll/interleukin-1 receptor domain NADase activities in gnotobiotic mice and Bangladeshi children with malnutrition. Cell Rep. 2022 Apr 26;39(4):110738. doi: 10.1016/j.celrep.2022.110738.

  PMID: 35476981 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2013
• First Posted: June 28, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 11, 2022

Record last verified: 2015-06

Locations

BA (1)