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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 : December 21, 2022
Sponsor:
Collaborator:
UNICEF
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

Tracking Information
First Submitted Date  ICMJE May 19, 2022
First Posted Date  ICMJE August 30, 2022
Last Update Posted Date December 21, 2022
Estimated Study Start Date  ICMJE January 1, 2023
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2022)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2022)
  • 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
  • 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
  • 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
  • Changes in weight [ Time Frame: 90 days ]
    Changes in body weight measured in kg
  • Changes in Mid Upper Arm Circumference (MUAC) [ Time Frame: 90 days ]
    Changes in Mid Upper Arm Circumference (MUAC) measured in mm or cm
  • Changes in height [ Time Frame: 90 days ]
    Changes in height measured in cm
  • Changes in weight-for-height Z score [ Time Frame: 90 days ]
    Changes in weight-for-height Z score measured in points
  • Changes in weight-for-age Z score [ Time Frame: 90 days ]
    Changes in weight-for-age Z score measured in points
  • Changes in height-for-age Z score [ Time Frame: 90 days ]
    Changes in height-for-age Z score measured in points
  • Proportion of children dropped out [ Time Frame: 90 days ]
    Proportion of children dropped out measured in percentage
  • 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
  • Proportion of children needed hospital admission after enrolment [ Time Frame: 90 days ]
    Proportion of children needed hospital admission after enrolment measured in percentage
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness Trial of Locally Developed Ready to Use Therapeutic Food
Official Title  ICMJE 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
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.

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). 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Sharnali-1 and Sharnali-2 would be provided 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
Condition  ICMJE Malnutrition Severe
Intervention  ICMJE
  • 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.

  • Dietary Supplement: Sharnali 2
    Sharnali 2 made from chick peas, dried skimmed milk, sugar, vegetable oils and micronutrient premix.
Study Arms  ICMJE
  • 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.
    Intervention: Dietary Supplement: Sharnali 1
  • 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.
    Intervention: Dietary Supplement: Sharnali 2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 29, 2022)
450
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2024
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 59 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Salam Khan +880-2-9827001-10 ext 3206 salamk@icddrb.org
Listed Location Countries  ICMJE Bangladesh
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05520879
Other Study ID Numbers  ICMJE PR-21014
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party International Centre for Diarrhoeal Disease Research, Bangladesh
Original Responsible Party Same as current
Current Study Sponsor  ICMJE International Centre for Diarrhoeal Disease Research, Bangladesh
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE UNICEF
Investigators  ICMJE
Study Director: Md Munirul Islam, PhD Scientist
Principal Investigator: Nurun Nahar Naila, MPH Assistant Scientist
PRS Account International Centre for Diarrhoeal Disease Research, Bangladesh
Verification Date December 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP