Comparison of Treatment of SAM in Children 6-59 Months With RUTF and RUSF in Umerkot, Sindh, Pakistan

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Severe Acute Malnutrition
• Intervention / Treatment: Dietary supplement: Ready-to-use therapeutic food (RUTF); Dietary supplement: Ready-to-use-supplementary food (RUSF)

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Umerkot, Sindh, Pakistan
      • 10 Basic Health Units (BHUs) operating by People's Primary Healthcare Initiative (PPHI)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 months to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment of SAM children with RUTF; Treatment of severe acute malnutrition (SAM) in children 6-59 months old with standard ready-to-use therapeutic food (RUTF)	Dietary supplement: Ready-to-use therapeutic food (RUTF); SAM children will receive approximately 190 kcal/kg/day of standard RUTF
Experimental: Treatment of SAM children with RUSF; Treatment of severe acute malnutrition (SAM) in children 6-59 months old with ready-to-use-supplementary food (RUSF)	Dietary supplement: Ready-to-use-supplementary food (RUSF); SAM children will receive approximately 190 kcal/kg/day of Acha Mum (AM-RUSF)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	4 weeks
Changes in mid-upper arm circumference (MUAC)	Changes in MUAC will be assessed by cm & mm	12 weeks
Changes in weight	Changes in weight will be assessed by grams	12 weeks
Changes in length	Changes in length will be assessed by cm	12 weeks
Time to recovery from SAM	Time to recovery from MAM defined as achieved a MUAC ≥12.5 cm	12 weeks
Relapse rate into SAM	Number of relapse in SAM will be identified after 3 months of follow-up	24 weeks
Non-responder children	Number of children who non-responded will be assessed in follow-up visits	12 weeks
Defaulter children	Number of defaulter children during the study will be assessed by follow-up visits	24 weeks
Adverse events	Number of adverse events (if any) will be identified in follow-up visits	24 weeks

Collaborators and Investigators

• Sponsor: Aga Khan University
• Collaborators: United Nations World Food Programme (WFP); People's Primary Healthcare Initiative (PPHI), Sindh

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): July 31, 2021
• Study Completion (Anticipated): October 31, 2021

Study Registration Dates

• First Submitted: November 21, 2019
• First Submitted That Met QC Criteria: November 21, 2019
• First Posted (Actual): November 22, 2019

Study Record Updates

• Last Update Posted (Actual): May 19, 2021
• Last Update Submitted That Met QC Criteria: May 17, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Severe Acute Malnutrition
• Other Study ID Numbers: 2019-1615-4895

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: De-identified data will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No