Ignite Creation Date:
2024-05-06 @ 6:03 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05520879
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-12-21
First Post:
2022-05-19
Brief Title:
Effectiveness Trial of Locally Developed Ready to Use Therapeutic Food
Sponsor:
International Centre for Diarrhoeal Disease Research Bangladesh
Organization:
International Centre for Diarrhoeal Disease Research Bangladesh
Study Overview
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 Coxs Bazar
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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 icddrb 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 1000000 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 maternalcaregiver 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 icddrb 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 Coxs 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 WLZWHZ -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
Poor health conditions and malnutrition are major issues confronting the influx of about 1000000 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 maternalcaregiver 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 icddrb 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 Coxs 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 WLZWHZ -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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None