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

NCT01331044 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2015-07-28

No results posted yet for this study

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).

Conditions

  • Severe Acute Malnutrition

Interventions

DIETARY_SUPPLEMENT

Plumpy Nut

to RUTF will receive commercially available RUTF (Plumpy nut) in a total of 200 kcal/kg.day in a sequential manner (Plumpy nut will be offered \~ 125 kcal/kg in 1st 24 hours, \~ 150 kcal/kg in 2nd 24 hours, then\~200k cal/kg by the third day).

DIETARY_SUPPLEMENT

Khichuri and Halwa

Day 1: Milk suji, 10ml/kg/ feed for 11 feed \& halwa 10gm/kg; 2 feed per day 125kcal/kg.day Day 2: Milk suji, 10ml/kg/ feed for 11 feed \& halwa 10gm/kg; 2 feed per day \& khichuri 10gm/kg; 2 feed per day 150kcal/kg.day Day 3: Milk suji 100, 10ml/kg/ feed for 11 feed \& halwa 10gm/kg; 2 feed per day \& khichuri 10gm/kg; 2 feed per day 175kcal/kg.day Day 4: Milk suji 100, 10ml/kg/ feed for 11 feed \& halwa 10gm/kg; 3 feed per day \& khichuri 10gm/kg; 3 feed per day 200kcal/kg.day Day 5 onward: Milk suji 100, 10ml/kg/ feed 6 hourly (4 feed per day) \& halwa 20gm/kg; 3 feed per day \& khichuri 20gm/kg; 3 feed per day 200kcal/kg.day

Sponsors & Collaborators

  • International Atomic Energy Agency

    collaborator OTHER_GOV

  • Washington University School of Medicine

    collaborator OTHER

  • University of Virginia

    collaborator OTHER

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    lead OTHER

Principal Investigators

  • Sayeeda Huq, MBBS, MIPH · International Centre for Diarrhoea Diseases Research, Bangladesh

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01331044 on ClinicalTrials.gov