Clinical Trial: Ready to Use Therapeutic Food (RUTF) in Severe Malnourished Children

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Efficacy and Acceptability of Ready to Use Therapeutic Food (RUTF) in Children Aged 6-24 Months With Severe Acute Malnutrition in Bangladesh

Brief Summary:

  1. RUTF would be more effective (quicker catch-up growth by promoting more tissue accrue resulting decrease stay in rehabilitation ward) in treating children with SAM during the rehabilitation phase than khichuri /halwa;
  2. RUTF would be acceptable to the children and their mothers/caregivers;
  3. Malnutrition is not caused solely by lack of food, but also by impaired utilization of the food that is ingested. The ability of the gut to absorb nutrients from the diet is associated with the host's 'human' genotype, the host's gut microbiota and its gene content (the microbiome).

Detailed Summary:

We propose to conduct a research study to compare the acceptability and efficacy of RUTF with that of the cereal-based diets in the management of hospitalised SAM children in Bangladesh. After completion of the initial acute phase treatment (for diarrhoea, lower respiratory tract infection/pneumonia, severe anaemia, fever, sepsis, electrolyte imbalance, and/or anorexia) in the Longer Stay Ward/ Special Care Ward of the Dhaka Hospital, the children will be transferred to the NRW according to the enrolment criteria. Once the children fulfil all the criteria for entry into the study and written consent to their participation is obtained from respective parents/guardian, they will be randomly allocated to: (i) the standard cereal-based foods, namely khichuri and halwa, or (ii) RUTF. Randomization will be done according to computer-generated random numbers using permuted blocks with block lengths of four and six. For understandable reasons, the dietary therapy can't be blinded. The assigned treatment packages will be kept in closed opaque envelopes until the same serial number is assigned to an enrolled child. Participating children will be discharged from NRW according to the new WHO growth standard (WHO, 2009), which explicit , at least after seven days stay completed there or until achieving a weight gain of 15% , for non-oedematous child. On the other hand for oedematous child after oedema free if WHZ is ≥-3; however if oedema free WHZ is <- 3 then the child will be discharge after achieving 15% weight gain. In both the groups, the acceptability of the allocated diet, both by the children and their respective mothers/caregivers, the rate of weight gain and anthropometric measurements, and adverse event will be systematically recorded for analyses. Khichuri/halwa group will be given diet as per standardized management protocol of NRW of the Dhaka Hospital. On the other hand, children allocated to RUTF will receive
Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh

Current Primary Outcome: Rate of weight gain [ Time Frame: 14 days ]

During stay in nutrition rehabilitation unit, Dhaka Hospital


Original Primary Outcome: Same as current

Current Secondary Outcome: Days require to achieve oedema free discharge criteria and other anthropometric changes [ Time Frame: 14 days ]

Weight for length -2 SD or 15 percent weight gain


Original Secondary Outcome: Same as current

Information By: International Centre for Diarrhoeal Disease Research, Bangladesh

Dates:
Date Received: April 6, 2011
Date Started: October 2009
Date Completion:
Last Updated: July 26, 2015
Last Verified: June 2015