Alternative Feeding Regimen on Recovery of Children Aged 6-59 Months With Moderate Acute Malnutrition in Bangladesh.

NCT06045104 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 560

Last updated 2023-10-13

No results posted yet for this study

Summary

In spite of the large burden of acute malnutrition in the country, the Community-based Management of Acute Malnutrition (CMAM) protocol approved in Bangladesh highly deviates from the WHO normative guidance, in that it does not support the use of any currently existing nutritional products for Moderate Acute Malnutrition (MAM) cases: it relies solely on nutrition counselling. On another hand, some non-governmental organizations (NGOs) are implementing programs making a standard use of specialized nutritional products, such as nutritional supplements like Wheat Soy Blend (WSB)++ to manage MAM cases, in children of Forcibly Displaced Myanmar Nationals (FDMNs) in the refugee camps situated at the south-eastern region of the country and in some crisis-affected districts as well.

The "no-food" CMAM policy for MAM is decreasing the cost of treatment, yet this may undermine effectiveness and impact. In this context, policy makers need evidence regarding context specific, effective and scalable interventions for CMAM.

This cluster randomized control trial (cRCT) will be conducted in the host communities in Teknaf and Ukhiya sub-districts of Cox's Bazar district of Bangladesh among children aged 6-59 months suffering from MAM who will be assigned to receive either of the 2 different treatment packages for a period of 4 months (120 days). Then followed up for 6 months (180 days) post treatment completion. Each arm will consist of 280 children with MAM. Both the arms will receive nutrition counselling along with the study intervention, as follows:

In the first arm, the treatment packages for children with MAM will include a standard use of specialized nutritional products developed to address the nutritional needs of these children in acute crisis/emergency settings and widely used internationally: children with MAM will receive WSB++ with nutrition counselling for a period of 4 months (120 days),.

In the second arm, children with MAM will receive 15 MNP with improved nutrition counselling for a period of 4 months (120 days).

A cluster sampling technique will be used to enroll participants. Each Community Clinic and Union Health \& Family Welfare Centers will serve as unit of cluster for the randomization.

Primary outcome variables are: 1) Daily weight gain (g/kg/d) between enrolment and end of the treatment period. 2) Recovery rate (%) at the end of the treatment period.

Conditions

  • Moderate Acute Malnutrition

Interventions

DIETARY_SUPPLEMENT

Wheat Soy Blend Plus Plus (WSB++) with nutrition counselling

Wheat Soy Blend Plus Plus (WSB++) with nutrition counselling

DIETARY_SUPPLEMENT

15 Micro Nutrient Powder (15 MNP) with improved nutrition counselling

15 Micro Nutrient Powder (15 MNP) with improved nutrition counselling

Sponsors & Collaborators

  • Action Contre la Faim

    collaborator OTHER
  • University Ghent

    collaborator OTHER
  • United Nations World Food Programme (WFP)

    collaborator OTHER
  • International Centre for Diarrhoeal Disease Research, Bangladesh

    lead OTHER

Principal Investigators

  • Md Munirul Islam, PhD · Scientist

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-20
Primary Completion
2025-04-30
Completion
2025-04-30

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 NCT06045104 on ClinicalTrials.gov