Comparison of Treatment of SAM in Children 6-59 Months With RUTF and RUSF in Umerkot, Sindh, Pakistan
- Conditions
- Severe Acute Malnutrition
- Interventions
- Dietary Supplement: Ready-to-use therapeutic food (RUTF)Dietary Supplement: Ready-to-use-supplementary food (RUSF)
- Registration Number
- NCT04174846
- Lead Sponsor
- Aga Khan University
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Children aged 6-59 months with SAM, i.e. MUAC <11.5 cm
- Bilateral pitting oedema (+,++)
- Appetite
- Without medical complications
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment of SAM children with RUTF Ready-to-use therapeutic food (RUTF) Treatment of severe acute malnutrition (SAM) in children 6-59 months old with standard ready-to-use therapeutic food (RUTF) Treatment of SAM children with RUSF Ready-to-use-supplementary food (RUSF) Treatment of severe acute malnutrition (SAM) in children 6-59 months old with ready-to-use-supplementary food (RUSF)
- Primary Outcome Measures
Name Time Method Recovery rate from SAM 12 weeks 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
Name Time Method Changes in mid-upper arm circumference (MUAC) 12 weeks Changes in MUAC will be assessed by cm \& mm
Changes in length 12 weeks Changes in length will be assessed by cm
Neurocognitive performance after first 4 weeks of treatment 4 weeks Neurocognitive performance after first 4 weeks of treatment as assessed by eye tracking and infant problem solving
Changes in weight 12 weeks Changes in weight will be assessed by grams
Time to recovery from SAM 12 weeks Time to recovery from MAM defined as achieved a MUAC ≥12.5 cm
Relapse rate into SAM 24 weeks Number of relapse in SAM will be identified after 3 months of follow-up
Non-responder children 12 weeks Number of children who non-responded will be assessed in follow-up visits
Defaulter children 24 weeks Number of defaulter children during the study will be assessed by follow-up visits
Adverse events 24 weeks Number of adverse events (if any) will be identified in follow-up visits
Trial Locations
- Locations (1)
10 Basic Health Units (BHUs) operating by People's Primary Healthcare Initiative (PPHI)
🇵🇰Umerkot, Sindh, Pakistan