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

NCT06045104 | Unknown

• 1 other identifier: PR-22128-A
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Moderate Acute Malnutrition; Children; Wheat Soy Blend ++; 15 MNP

Outcome Measures

Primary Outcomes (3)

• Rate of weight gain (g/kg/d)

  Daily weight gain (g/kg/d) between enrolment and end of the treatment period. If recovery was reached before the full duration of the treatment, daily weight gain will be calculated between enrolment and recovery, without stopping the treatment.

  4 months or 120 days

• Recovery rate (%)

  Recovery rate (%) at the end of the treatment period

  4 months or 120 days

• Free from acute malnutrition

  Proportion of children free from acute malnutrition at the end of the treatment period

  4 months or 120 days

Secondary Outcomes (5)

• Proportion of non-response, death, defaulter and regression of MAM to SAM

  4 months or 120 days

• Incidence of relapse during a period of 6 months (180 days) post-treatment

  6 months or 180 days post treatment

• Change in lean and fat mass between enrollment and end of the treatment period

  4 months or 120 days) and 6 months post-treatment

• Prevalence of concurrent infections at the end of the treatment period

  4 months or 120 days) and 6 months post-treatment

• Motor, language, and personal-social development at the end of the treatment period

  4 months or 120 days) and 6 months post-treatment

Study Arms (2)

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

ACTIVE COMPARATOR

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

Dietary Supplement: Wheat Soy Blend Plus Plus (WSB++) with nutrition counselling

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

EXPERIMENTAL

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

Dietary Supplement: 15 Micro Nutrient Powder (15 MNP) with improved nutrition counselling

Interventions

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

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

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

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

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

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

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children of either sex, aged between 6-59 months having MUAC \<125 mm and/or WHZ/WLZ \<-2 SD
• Absence of edema or morbidities that necessitate hospitalization
• Children with appetite
• Mothers/caregivers sign the consent form
• Willing to bring the child to the study site every two weeks for MAM and have a plan to stay in the community for at least next 9-10 months.
• Accept the intervention package and home visits for data collection and morbidity follow up

You may not qualify if:

• Bipedal edema
• MAM with clinically severe anemia, suspected tuberculosis, other chronic diseases or any congenital disorder or deformity, an ongoing episode of diarrhea, a history of persistent diarrhea in the past month.

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• Action Contre la Faim: collaborator
• University Ghent: collaborator
• United Nations World Food Programme (WFP): collaborator

Study Sites (1)

Community Clinics

Teknāf, 4760, Bangladesh

Location

Study Officials

• Md Munirul Islam, PhD

  Scientist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

M Munirul Islam, PhD

CONTACT

+8801713006878; mislam@icddrb.org

Md Munirul Islam, PhD

CONTACT

+8801713006878; mislam@icddrb.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 21, 2023
• Study Start: October 20, 2023
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: October 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)