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

Severe Acute Malnutrition Clinical Trial

— RUTF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01331044
• Other study ID #: PR-09023
• Status: Completed
• Phase: N/A
• First received: April 6, 2011
• Last updated: July 26, 2015
• Start date: October 2009
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: International Centre for Diarrhoeal Disease Research, Bangladesh
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bangladesh: Ethical Review Committee
• Study type: Interventional

Clinical Trial 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).

Description:

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 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). We will also examine if the weight gain of the children is associated with increase in the lean body mass or in the body fat mass by assessing their body composition, Changes in body composition after dietary intervention in SAM children will be assessed by non-invasive technique using stable isotope tracer (deuterium oxide). For this, after collection of baseline urine and saliva samples a known quantity (5 gm) of deuterium oxide labelled water will be given to all study children. Enrichment of deuterium in body water will be measured to estimate total body water (TBW). Enrichment reaches a plateau after 3-5 hours. According to the recommendation from International Atomic Energy Agency (IAEA) field manual, two post-dose saliva samples will be collected at 3rd and 4th hours. The concentrations of deuterium in saliva samples will be measured with Fourier Transform Infrared Spectrometer (FTIR). The urine specimens will be analyzed using Isotope Ratio Mass Spectrometry (IRMS). From measured TBW we would estimate the fat free mass (FFM). Body fat mass (FM) is the difference between body weight and fat free mass. This procedure will be repeated in same sequence in all study children at the end of dietary intervention when the study child achieve discharge criteria. In addition to the above mentioned procedures, anthropometric measures such as mid-arm circumference, triceps skin fold thickness, arm fat area and arm muscle area would also be routinely recorded along with other morbidity data.

We wish to leverage the ongoing scientific collaboration among University of Virginia, Center for Genome Sciences at Washington University School of Medicine, USA and ICDDR,B to gain insight into the influence of human genetic polymorphisms and gut microbiome on malnutrition, in order to provide a foundation for new treatment and prevention programs on a population-wide basis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 24 Months

Eligibility

Inclusion Criteria:

1. Children with SAM, defined as WH <- 3 Z score of WHO standard and/or bipedal nutritional oedema (according to WHO growth standard)

2. Sex: Either

3. Age: 6-24 months

4. Completed acute (stabilization) phase management and regaining appetite

5. No signs of concurrent infection (e.g. diarrhoea, lower respiratory tract infection/pneumonia, severe anaemia, fever, sepsis, electrolyte imbalance, etc.)

6. Mothers/caregivers agreed to stay in the NRW until child achieve desired discharged criteria.

7. Informed consent given by the parent or guardian.

Exclusion Criteria:

1. Children without fixed residential address

2. Children with tuberculosis or any congenital/acquired disorder

3. Any physical condition that affects normal feeding of the children e.g. Cleft lip or palate.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Malnutrition
• Severe Acute Malnutrition

Intervention

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).
• 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

Locations

Country	Name	City	State
Bangladesh	International Centre for Diarrhoeal Diseases Research, Bangladesh	Dhaka

Sponsors (4)

Lead Sponsor	Collaborator
International Centre for Diarrhoeal Disease Research, Bangladesh	International Atomic Energy Agency, University of Virginia, Washington University School of Medicine

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of weight gain	During stay in nutrition rehabilitation unit, Dhaka Hospital	14 days	No
Secondary	Days require to achieve oedema free discharge criteria and other anthropometric changes	Weight for length -2 SD or 15 percent weight gain	14 days	No