NCT01331044

Brief Summary

  1. 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. 2.RUTF would be acceptable to the children and their mothers/caregivers;
  3. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 7, 2011

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

July 28, 2015

Status Verified

June 1, 2015

Enrollment Period

5.7 years

First QC Date

April 6, 2011

Last Update Submit

July 26, 2015

Conditions

Severe Acute Malnutrition

Keywords

RUTFSevere Acute MalnutritionChildrenBody compositionMicrobiotaShort Chain Fatty AcidAcceptability of RUTFEdema free 15 percent weight gainChanges in body compositionGut microbiotaGenome wide association

Outcome Measures

Primary Outcomes (1)

  • Rate of weight gain

    During stay in nutrition rehabilitation unit, Dhaka Hospital

    14 days

Secondary Outcomes (1)

  • Days require to achieve oedema free discharge criteria and other anthropometric changes

    14 days

Study Arms (2)

RUTF

EXPERIMENTAL

Ready to use Therapeutic Food (RUTF) Plumpy nut.

Dietary Supplement: Plumpy Nut

Khichuri - Halwa

ACTIVE COMPARATOR

Cereal Legume

Dietary Supplement: Khichuri and Halwa

Interventions

Plumpy NutDIETARY_SUPPLEMENT

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).

RUTF
Khichuri and HalwaDIETARY_SUPPLEMENT

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

Khichuri - Halwa

Eligibility Criteria

Age6 Months - 24 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children with SAM, defined as WH \<- 3 Z score of WHO standard and/or bipedal nutritional oedema (according to WHO growth standard)
  • Sex: Either
  • Age: 6-24 months
  • Completed acute (stabilization) phase management and regaining appetite
  • No signs of concurrent infection (e.g. diarrhoea, lower respiratory tract infection/pneumonia, severe anaemia, fever, sepsis, electrolyte imbalance, etc.)
  • Mothers/caregivers agreed to stay in the NRW until child achieve desired discharged criteria.
  • Informed consent given by the parent or guardian.

You may not qualify if:

  • Children without fixed residential address
  • Children with tuberculosis or any congenital/acquired disorder
  • Any physical condition that affects normal feeding of the children e.g. Cleft lip or palate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Centre for Diarrhoeal Diseases Research, Bangladesh

Dhaka, 1212, Bangladesh

Location

MeSH Terms

Conditions

Severe Acute Malnutrition

Condition Hierarchy (Ancestors)

MalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Sayeeda Huq, MBBS, MIPH

    International Centre for Diarrhoea Diseases Research, Bangladesh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2011

First Posted

April 7, 2011

Study Start

October 1, 2009

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

July 28, 2015

Record last verified: 2015-06

Locations

BA(1)