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Effectiveness Trial of Locally Developed Ready to Use Therapeutic Food

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ClinicalTrials.gov Identifier: NCT05520879
Recruitment Status : Not yet recruiting
First Posted : August 30, 2022
Last Update Posted : August 30, 2022
Sponsor:
Collaborator:
UNICEF
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

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 ourselves 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.


Condition or disease Intervention/treatment Phase
Malnutrition Severe Dietary Supplement: Sharnali 1 Dietary Supplement: Sharnali 2 Not Applicable

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, 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). We 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, we also need to explore their perception, belief and practices if we provide NMs and RUTF in that community. Unexpectedly, there is no data available on how they perceive about SAM management and how they would response if we implement such service. Therefore, we would like to explore maternal/caregiver perception, knowledge, practices and barriers towards community-based health care management among FDMN population.

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:

We will conduct the effectiveness trial of the Bangladeshi NMs in the FDMN Camps in 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: We will provide Sharnali-1 and Sharnali-2 among 450 severely acute malnourished children divided into two groups 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The intervention study products will be packaged in sachets that cannot be differentiated between the two.
Primary Purpose: Treatment
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
Estimated Study Start Date : October 1, 2022
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Arm Intervention/treatment
Experimental: To provide Sharnali-1 to severe acute malnourished children
We will provide Sharnali-1 among 225 severe acute malnourished children 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.
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.


Experimental: To provide Sharnali-2 to severe acute malnourished children
We will provide Sharnali-2 among 225 severely acute malnourished children 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.
Dietary Supplement: Sharnali 2
Sharnali 2 made from chick peas, dried skimmed milk, sugar, vegetable oils and micronutrient premix.




Primary Outcome Measures :
  1. Proportion of children graduating from SAM to non-acute malnutrition status [ Time Frame: 90 days ]
    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


Secondary Outcome Measures :
  1. Time (days) required to graduate from SAM to non-acute malnutrition status [ Time Frame: 90 days ]
    Required Time for graduation from SAM to non acute malnutrition measured in days

  2. Rate of weight gain of children (g/kg per day) during 1st 2 weeks, 1st 4 weeks and up to graduation [ Time Frame: 90 days ]
    Children's weight gain measured as g/kg/day

  3. Proportion of children recovered (MUAC ≥ 125 mm or WLZ/WHZ ≥ -2) by different time periods [ Time Frame: 90 days ]
    Proportion of recovery at different time points measured as percentage

  4. Changes in weight [ Time Frame: 90 days ]
    Changes in body weight measured in kg

  5. Changes in Mid Upper Arm Circumference (MUAC) [ Time Frame: 90 days ]
    Changes in Mid Upper Arm Circumference (MUAC) measured in mm or cm

  6. Changes in height [ Time Frame: 90 days ]
    Changes in height measured in cm

  7. Changes in weight-for-height Z score [ Time Frame: 90 days ]
    Changes in weight-for-height Z score measured in points

  8. Changes in weight-for-age Z score [ Time Frame: 90 days ]
    Changes in weight-for-age Z score measured in points

  9. Changes in height-for-age Z score [ Time Frame: 90 days ]
    Changes in height-for-age Z score measured in points

  10. Proportion of children dropped out [ Time Frame: 90 days ]
    Proportion of children dropped out measured in percentage

  11. Proportion of children relapsed (deterioration of weight, appearance of edema or any clinical emergencies) [ Time Frame: 90 days ]
    Proportion of children relapsed (deterioration of weight, appearance of edema or any clinical emergencies) measured in percentage

  12. Proportion of children needed hospital admission after enrolment [ Time Frame: 90 days ]
    Proportion of children needed hospital admission after enrolment measured in percentage



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05520879


Contacts
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Contact: Salam Khan +880-2-9827001-10 ext 3206 salamk@icddrb.org

Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
UNICEF
Investigators
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Study Director: Md Munirul Islam, PhD Scientist
Principal Investigator: Nurun Nahar Naila, MPH Assistant Scientist
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Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT05520879    
Other Study ID Numbers: PR-21014
First Posted: August 30, 2022    Key Record Dates
Last Update Posted: August 30, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Severe Acute Malnutrition
Local RUTF
Effectiveness Trial
Forcibly Displaced Myanmar Nationals
Bangladesh
Additional relevant MeSH terms:
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Malnutrition
Severe Acute Malnutrition
Nutrition Disorders