Effectiveness Trial of Locally Developed Ready to Use Therapeutic Food

Malnutrition Severe Clinical Trial

Official title:

Community-based Management of Acute Malnutrition (CMAM) in Bangladesh: Effectiveness Trial of Locally Developed Ready-to-use Therapeutic Food in the Treatment of Severe Acute Malnutrition in Rohingya Camps in Cox's Bazar

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05520879
• Other study ID #: PR-21014
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2022
• Source: International Centre for Diarrhoeal Disease Research, Bangladesh
• Contact: Salam Khan
• Phone: +880-2-9827001-10
• Email: salamk[@]icddrb.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

As poor health conditions and malnutrition are major issues confronting the influx of Forcibly Displaced Myanmar Nationals (FDMN), there is an urgent need to prepare the service providers to control the situation and to prevent deaths and disabilities in FDMN children suffering from severe acute malnutrition (SAM). It is therefore imperative to assess the effectiveness of the two local Nutrition Managements (NMs); Sharnali 1 & Sharnali 2 for the treatment of SAM in an emergency in Bangladesh.

If the effectiveness trial shows that the NMs are effective, either one or both varieties can be used for children with SAM in emergency situations. Ultimately a Bangladeshi solution will replace the expensive RUTF that is currently being imported for use in the FDMN camps for management of SAM.

Description:

In response to the huge global burden of childhood acute malnutrition, WHO and UNICEF have recommended since 2007 ready-to-use therapeutic food (RUTF) as the treatment for children with severe acute malnutrition (SAM) without complications in the community. Although there is no national program in Bangladesh for management of SAM in the community, the Ministry of Health and Family Welfare (MoHFW) has posited for a therapeutic food to manage childhood malnutrition that is made of locally available food ingredients. With this backdrop, icddr,b developed two types of such food called Nutritional Management (NM) for the management of uncomplicated SAM in the community. These NMs conform to the National Guidelines on Community-based Management of SAM of the Government of Bangladesh as well as WHO and UNICEF specifications. These newly developed therapeutic foods, named as Sharnali-1 and Sharnali-2, are made of locally available food ingredients including rice, lentils, and chickpeas respectively and a recently conducted trial assessing their acceptability among SAM children showed that the local Bangladeshi NMs are as acceptable as the imported RUTF (Annex1: Composition of the locally developed NMs). Same group of researchers also completed a randomized, double-blind efficacy trial among children with SAM in Dhaka and in Kurigram that revealed that the local NMs are as efficacious as the imported RUTF.

Poor health conditions and malnutrition are major issues confronting the influx of about 1000,000 Forcibly Displaced Myanmar Nationals (FDMN; the FDMN people from across the border into Bangladesh). It is unfortunately anticipated that the deadliest form of malnutrition - severe acute malnutrition (SAM) - will greatly exceed the current national prevalence as a result of severe food insecurity, disease, and the existing high levels of malnutrition among those who are crossing the border. There is an urgent need to prepare ourselves to control the situation and to prevent deaths and disabilities in refugee children suffering from SAM. It is therefore imperative to assess the effectiveness of the two local NMs for the treatment of SAM in an emergency situation in Bangladesh, the FDMN situation being one that demands urgent attention. If the effectiveness trial shows that the NMs are effective, either one or both varieties can be used for children with SAM in emergency situations where food insecurity is extreme. Ultimately, a Bangladeshi solution will replace the expensive RUTF that is currently being imported for use in the FDMN FDMN camps. On the other hand, researchers also want to explore their perception, belief and practices if NMs and RUTF in that community is being provided. Unexpectedly, there is no data available on how they perceive about SAM management and how they would response if the above mentioned services are implemented. Therefore, the researchers would like to explore maternal/caregiver perception, knowledge, practices and barriers towards community-based health care management among FDMN population as well.

The Ministry of Health and Family Welfare of Bangladesh has approved conduction of the trial of the local therapeutic foods, Sharnali-1 and Sharnali-2, developed by icddr,b among under-five children in FDMN Forcibly Displaced Myanmar National (FDMN) camps suffering from SAM.

Objectives:

To assess the effectiveness of two local NMs (Sharnali-1 and Sharnali-2) in managing 6-59 months old children suffering from SAM in the community in an emergency setting (for example, the Camps of Forcibly Displaced Myanmar Nationals).

Methods:

An effectiveness trial will be conducted using the Bangladeshi NMs in the FDMN Camps in Teknaf and Ukhiya sub-districts of Cox's Bazar district. The primary outcome variable of the effectiveness trial is to assess the proportion of children graduating from SAM to non-acute malnutrition status (MUAC ≥ 125 mm or WLZ/WHZ ≥ -2 for two consecutive weeks) by 90 days of intervention. The total number of participants enrolled for the effectiveness trial would be 450 children with SAM in two arms.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 450
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 59 Months

Eligibility

Inclusion Criteria:

• Severe acute malnourished children

• Age 6-59 months

• Either sex

• No medical complication

• MUAC <115 mm and/or WLZ/WHZ <-3.

Exclusion Criteria:

• Children not suffering from severe acute malnutrition

• Children with oedematous malnutrition

• Failed to obtain consent for study participation from parents or legal guardian

• Suffering from any chronic illness(es) etc.

Related Conditions & MeSH terms

• Malnutrition
• Malnutrition Severe
• Severe Acute Malnutrition

Intervention

Dietary Supplement:
• Sharnali 1
The intervention is food product, made from locally available food ingredients in Bangladesh. Sharnali 1 made from rice, lentil, dried skimmed milk, sugar, vegetable oils and micronutrient premix.
• Sharnali 2
Sharnali 2 made from chick peas, dried skimmed milk, sugar, vegetable oils and micronutrient premix.

Locations

Country	Name	City	State
Bangladesh	International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)	Teknaf	Cox's Bazar
Bangladesh	International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)	Ukhiya	Cox's Bazar

Sponsors (2)

Lead Sponsor	Collaborator
International Centre for Diarrhoeal Disease Research, Bangladesh	UNICEF

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of children graduating from SAM to non-acute malnutrition status	The primary outcome variable is to assess the proportion of children graduating from SAM to non-acute malnutrition status (MUAC = 125 mm or WLZ/WHZ = -2 for two consecutive weeks) by 90 days of intervention	90 days
Secondary	Time (days) required to graduate from SAM to non-acute malnutrition status	Required Time for graduation from SAM to non acute malnutrition measured in days	90 days
Secondary	Rate of weight gain of children (g/kg per day) during 1st 2 weeks, 1st 4 weeks and up to graduation	Children's weight gain measured as g/kg/day	90 days
Secondary	Proportion of children recovered (MUAC = 125 mm or WLZ/WHZ = -2) by different time periods	Proportion of recovery at different time points measured as percentage	90 days
Secondary	Changes in weight	Changes in body weight measured in kg	90 days
Secondary	Changes in Mid Upper Arm Circumference (MUAC)	Changes in Mid Upper Arm Circumference (MUAC) measured in mm or cm	90 days
Secondary	Changes in height	Changes in height measured in cm	90 days
Secondary	Changes in weight-for-height Z score	Changes in weight-for-height Z score measured in points	90 days
Secondary	Changes in weight-for-age Z score	Changes in weight-for-age Z score measured in points	90 days
Secondary	Changes in height-for-age Z score	Changes in height-for-age Z score measured in points	90 days
Secondary	Proportion of children dropped out	Proportion of children dropped out measured in percentage	90 days
Secondary	Proportion of children relapsed (deterioration of weight, appearance of edema or any clinical emergencies)	Proportion of children relapsed (deterioration of weight, appearance of edema or any clinical emergencies) measured in percentage	90 days
Secondary	Proportion of children needed hospital admission after enrolment	Proportion of children needed hospital admission after enrolment measured in percentage	90 days