Comparison of Treatment of SAM in Children 6-59 Months With RUTF and RUSF in Umerkot, Sindh, Pakistan
Primary Purpose
Severe Acute Malnutrition
Status
Withdrawn
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Ready-to-use therapeutic food (RUTF)
Ready-to-use-supplementary food (RUSF)
Sponsored by
About this trial
This is an interventional treatment trial for Severe Acute Malnutrition
Eligibility Criteria
Inclusion Criteria:
- Children aged 6-59 months with SAM, i.e. MUAC <11.5 cm
- Bilateral pitting oedema (+,++)
- Appetite
- Without medical complications
Exclusion Criteria:
- Children will be excluded if they were simultaneously involved in another research trial or supplemental feeding program
- Developmentally delayed
- Have a chronic debilitating illness such as cerebral palsy (not including HIV or TB)
- Had a history of milk or peanut allergy.
Sites / Locations
- 10 Basic Health Units (BHUs) operating by People's Primary Healthcare Initiative (PPHI)
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Treatment of SAM children with RUTF
Treatment of SAM children with RUSF
Arm Description
Treatment of severe acute malnutrition (SAM) in children 6-59 months old with standard ready-to-use therapeutic food (RUTF)
Treatment of severe acute malnutrition (SAM) in children 6-59 months old with ready-to-use-supplementary food (RUSF)
Outcomes
Primary Outcome Measures
Recovery rate from SAM
Number of children recovered from SAM, defined as: MUAC ≥ 11.5cm (for two consecutive weekly visits), clinically well, no bilateral pitting oedema (for two consecutive weekly visits)
Secondary Outcome Measures
Neurocognitive performance after first 4 weeks of treatment
Neurocognitive performance after first 4 weeks of treatment as assessed by eye tracking and infant problem solving
Changes in mid-upper arm circumference (MUAC)
Changes in MUAC will be assessed by cm & mm
Changes in weight
Changes in weight will be assessed by grams
Changes in length
Changes in length will be assessed by cm
Time to recovery from SAM
Time to recovery from MAM defined as achieved a MUAC ≥12.5 cm
Relapse rate into SAM
Number of relapse in SAM will be identified after 3 months of follow-up
Non-responder children
Number of children who non-responded will be assessed in follow-up visits
Defaulter children
Number of defaulter children during the study will be assessed by follow-up visits
Adverse events
Number of adverse events (if any) will be identified in follow-up visits
Full Information
NCT ID
NCT04174846
First Posted
November 21, 2019
Last Updated
May 17, 2021
Sponsor
Aga Khan University
Collaborators
United Nations World Food Programme (WFP), People's Primary Healthcare Initiative (PPHI), Sindh
1. Study Identification
Unique Protocol Identification Number
NCT04174846
Brief Title
Comparison of Treatment of SAM in Children 6-59 Months With RUTF and RUSF in Umerkot, Sindh, Pakistan
Official Title
Comparison of Treatment of Severe Acute Malnutrition in Children 6-59 Months Old With Ready-to-use Therapeutic Food and Ready-to-use-supplementary Food: An Individual Randomized, Double-Blind, Controlled, Clinical Non-Inferiority Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Due to COVID-19
Study Start Date
January 2021 (Anticipated)
Primary Completion Date
July 31, 2021 (Anticipated)
Study Completion Date
October 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University
Collaborators
United Nations World Food Programme (WFP), People's Primary Healthcare Initiative (PPHI), Sindh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In Pakistan, around 15% of children under five are wasted, which is almost twice that of the global prevalence 7.5%. There is a demand for a reliable and consistent locally available severe acute malnutrition (SAM) treatment option since currently the only option is to use an imported ready-to-use-therapeutic food (RUTF). While imported RUTF is successful for treatment of children with SAM, Pakistan is often faced with supply chain issues and consequentially management of SAM with RUTF is unreliable. The World Food Programme (WFP)'s work in Pakistan supports government-led efforts to improve food and nutrition security, including the development of Acha Mum, a chickpea containing lipid-based ready-to-use-food. Acha Mum replaces the peanut in standard RUTF formulation with chickpea, a locally available legume. Acha Mum is well accepted by children in Pakistan and is currently being used as a treatment for children with moderate acute malnutrition (MAM) in targeted supplementary feeding programs (TSFP) throughout the country. The broad objective of this clinical trial is to test the effectiveness of a chickpea-based specialized nutritious food Acha Mum, compared to a standard RUTF for the treatment of SAM. The study will be conducted in 10 basic health units (BHUs) operating by PPHI in Umerkot district of Sindh, Pakistan. This will be an individual randomized, double-blinded, controlled clinical non-inferiority trial assessing the treatment of SAM with one of two therapeutic foods. A total of 1700 children will be part of the study (850 children in RUTF and 850 children in Acha Mum group). Children aged 6-59 months with SAM, i.e. MUAC <11.5 cm and/or with bilateral pitting oedema (+, ++), with appetite and without medical complications presenting at selected rural therapeutic feeding clinics. The primary outcome is recovery from SAM, defined as: MUAC ≥ 11.5cm (for two consecutive weekly visits), clinically well, no bilateral pitting oedema (for two consecutive weekly visits). The secondary outcomes include neurocognitive performance after first 4 weeks of treatment as assessed by eye tracking and infant problem solving; changes in MUAC, weight, and length; time to recovery from SAM; time to recovery from MAM defined as achieved a MUAC ≥12.5 cm; relapse into MAM; relapse into SAM and any adverse events.
Detailed Description
Rationale: In Pakistan, around 15% of children under five are wasted, which is almost twice that of the global prevalence 7.5%. There is a demand for a reliable and consistent locally available severe acute malnutrition (SAM) treatment option since currently the only option is to use an imported ready-to-use-therapeutic food (RUTF). While imported RUTF is successful for treatment of children with SAM, Pakistan is often faced with supply chain issues and consequentially management of SAM with RUTF is unreliable. The World Food Programme (WFP)'s work in Pakistan supports government-led efforts to improve food and nutrition security, including the development of Acha Mum, a chickpea containing lipid-based ready-to-use-food. Acha Mum replaces the peanut in standard RUTF formulation with chickpea, a locally available legume. Acha Mum is well accepted by children in Pakistan and is currently being used as a treatment for children with moderate acute malnutrition (MAM) in targeted supplementary feeding programs (TSFP) throughout the country.
Objectives: The broad objective of this clinical trial is to test the effectiveness of a chickpea-based specialized nutritious food Acha Mum, compared to a standard RUTF for the treatment of SAM.
Study Area: The study will be conducted in 10 basic health units (BHUs) operating by PPHI in Umerkot district of Sindh, Pakistan.
Study Design: This will be an individual randomized, double-blinded, controlled clinical non-inferiority trial assessing the treatment of SAM with one of two therapeutic foods.
Sample Size: A total of 1700 children will be part of the study (850 children in RUTF and 850 children in Acha Mum group).
Study Population: Children aged 6-59 months with SAM, i.e. MUAC <11.5 cm and/or with bilateral pitting oedema (+, ++), with appetite and without medical complications presenting at selected rural therapeutic feeding clinics.
Timeline: The duration of study will be 24 months (3 months for protocol and tool development, 18 months for enrollment and follow-ups and 3 months for data cleaning, analysis and report writing.
Expected outcomes: The primary outcome is recovery from SAM, defined as: MUAC ≥ 11.5cm (for two consecutive weekly visits), clinically well, no bilateral pitting oedema (for two consecutive weekly visits). The secondary outcomes include neurocognitive performance after first 4 weeks of treatment as assessed by eye tracking and infant problem solving; changes in MUAC, weight, and length; time to recovery from SAM; time to recovery from MAM defined as achieved a MUAC ≥12.5 cm; relapse into MAM; relapse into SAM and any adverse events.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Acute Malnutrition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment of SAM children with RUTF
Arm Type
Active Comparator
Arm Description
Treatment of severe acute malnutrition (SAM) in children 6-59 months old with standard ready-to-use therapeutic food (RUTF)
Arm Title
Treatment of SAM children with RUSF
Arm Type
Experimental
Arm Description
Treatment of severe acute malnutrition (SAM) in children 6-59 months old with ready-to-use-supplementary food (RUSF)
Intervention Type
Dietary Supplement
Intervention Name(s)
Ready-to-use therapeutic food (RUTF)
Intervention Description
SAM children will receive approximately 190 kcal/kg/day of standard RUTF
Intervention Type
Dietary Supplement
Intervention Name(s)
Ready-to-use-supplementary food (RUSF)
Intervention Description
SAM children will receive approximately 190 kcal/kg/day of Acha Mum (AM-RUSF)
Primary Outcome Measure Information:
Title
Recovery rate from SAM
Description
Number of children recovered from SAM, defined as: MUAC ≥ 11.5cm (for two consecutive weekly visits), clinically well, no bilateral pitting oedema (for two consecutive weekly visits)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Neurocognitive performance after first 4 weeks of treatment
Description
Neurocognitive performance after first 4 weeks of treatment as assessed by eye tracking and infant problem solving
Time Frame
4 weeks
Title
Changes in mid-upper arm circumference (MUAC)
Description
Changes in MUAC will be assessed by cm & mm
Time Frame
12 weeks
Title
Changes in weight
Description
Changes in weight will be assessed by grams
Time Frame
12 weeks
Title
Changes in length
Description
Changes in length will be assessed by cm
Time Frame
12 weeks
Title
Time to recovery from SAM
Description
Time to recovery from MAM defined as achieved a MUAC ≥12.5 cm
Time Frame
12 weeks
Title
Relapse rate into SAM
Description
Number of relapse in SAM will be identified after 3 months of follow-up
Time Frame
24 weeks
Title
Non-responder children
Description
Number of children who non-responded will be assessed in follow-up visits
Time Frame
12 weeks
Title
Defaulter children
Description
Number of defaulter children during the study will be assessed by follow-up visits
Time Frame
24 weeks
Title
Adverse events
Description
Number of adverse events (if any) will be identified in follow-up visits
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children aged 6-59 months with SAM, i.e. MUAC <11.5 cm
Bilateral pitting oedema (+,++)
Appetite
Without medical complications
Exclusion Criteria:
Children will be excluded if they were simultaneously involved in another research trial or supplemental feeding program
Developmentally delayed
Have a chronic debilitating illness such as cerebral palsy (not including HIV or TB)
Had a history of milk or peanut allergy.
Facility Information:
Facility Name
10 Basic Health Units (BHUs) operating by People's Primary Healthcare Initiative (PPHI)
City
Umerkot
State/Province
Sindh
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
De-identified data will be shared
Learn more about this trial
Comparison of Treatment of SAM in Children 6-59 Months With RUTF and RUSF in Umerkot, Sindh, Pakistan
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