NCT01889329|CompletedPhase 2/3
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Sponsor study identifier
interventional
490
1 country
1
Study Start
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2015
Actual (reported)Study Completion
December 2015
Actual (reported)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)?
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2015
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
June 26, 2013
Actual (reported)June 28, 2013
Actual (reported)December 2015
Actual (reported)December 2015
Actual (reported)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
Made from local food ingredients
Made from local food ingredients
Made from peanut
Made from local food ingredients
Made from local food ingredients
International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)
Dhaka, 1212, Bangladesh
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.
490 participants (actual enrollment reported by the registry).
First Submitted
June 26, 2013
First Posted
June 28, 2013
Study Start
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
Commercially made from peanut paste
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Primary Completion
December 2015
Actual (reported)Study Completion
December 2015
Actual (reported)Last Updated
February 11, 2022
Record last verified: 2015-06
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Source: ClinicalTrials.gov.
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