Development and Field Testing of Ready-to-use-therapeutic Foods Made of Local Ingredients in Bang… (NCT01889329) | Clinical Trial Compass
CompletedPhase 2/3
Development and Field Testing of Ready-to-use-therapeutic Foods Made of Local Ingredients in Bangladesh for SAM Children
Bangladesh490 participantsStarted 2013-04
Plain-language 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)?
Who can participate
Age range
6 Months – 59 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Weight gain (g/kg/d)
Timeframe: Initially 3 months for the acceptability trial another 18 months will be required for the efficacy trial
Trial details
NCT IDNCT01889329
SponsorInternational Centre for Diarrhoeal Disease Research, Bangladesh