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

Severe Acute Malnutrition Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04174846
• Other study ID #: 2019-1615-4895
• Status: Withdrawn
• Phase: N/A
• Start date: January 2021
• Est. completion date: October 31, 2021

Study information

• Verified date: May 2021
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 59 Months

Eligibility

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.

Related Conditions & MeSH terms

• Malnutrition
• Severe Acute Malnutrition

Intervention

Dietary Supplement:
• Ready-to-use therapeutic food (RUTF)
SAM children will receive approximately 190 kcal/kg/day of standard RUTF
• Ready-to-use-supplementary food (RUSF)
SAM children will receive approximately 190 kcal/kg/day of Acha Mum (AM-RUSF)

Locations

Country	Name	City	State
Pakistan	10 Basic Health Units (BHUs) operating by People's Primary Healthcare Initiative (PPHI)	Umerkot	Sindh

Sponsors (3)

Lead Sponsor	Collaborator
Aga Khan University	People's Primary Healthcare Initiative (PPHI), Sindh, United Nations World Food Programme (WFP)

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery rate from SAM	Number of children recovered from SAM, de?ned as: MUAC = 11.5cm (for two consecutive weekly visits), clinically well, no bilateral pitting oedema (for two consecutive weekly visits)	12 weeks
Secondary	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
Secondary	Changes in mid-upper arm circumference (MUAC)	Changes in MUAC will be assessed by cm & mm	12 weeks
Secondary	Changes in weight	Changes in weight will be assessed by grams	12 weeks
Secondary	Changes in length	Changes in length will be assessed by cm	12 weeks
Secondary	Time to recovery from SAM	Time to recovery from MAM defined as achieved a MUAC =12.5 cm	12 weeks
Secondary	Relapse rate into SAM	Number of relapse in SAM will be identified after 3 months of follow-up	24 weeks
Secondary	Non-responder children	Number of children who non-responded will be assessed in follow-up visits	12 weeks
Secondary	Defaulter children	Number of defaulter children during the study will be assessed by follow-up visits	24 weeks
Secondary	Adverse events	Number of adverse events (if any) will be identified in follow-up visits	24 weeks