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

NCT04174846 | Withdrawn DMC

• 1 other identifier: 2019-1615-4895
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Acute Malnutrition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Neurocognitive performance after first 4 weeks of treatment

  4 weeks

• Changes in mid-upper arm circumference (MUAC)

  12 weeks

• Changes in weight

  12 weeks

• Changes in length

  12 weeks

• Time to recovery from SAM

  12 weeks

Study Arms (2)

Treatment of SAM children with RUTF

ACTIVE COMPARATOR

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)

Treatment of SAM children with RUSF

EXPERIMENTAL

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)

Interventions

Ready-to-use therapeutic food (RUTF) DIETARY_SUPPLEMENT

SAM children will receive approximately 190 kcal/kg/day of standard RUTF

Treatment of SAM children with RUTF

Ready-to-use-supplementary food (RUSF) DIETARY_SUPPLEMENT

SAM children will receive approximately 190 kcal/kg/day of Acha Mum (AM-RUSF)

Treatment of SAM children with RUSF

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 6-59 months with SAM, i.e. MUAC \<11.5 cm
• Bilateral pitting oedema (+,++)
• Appetite
• Without medical complications

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

10 Basic Health Units (BHUs) operating by People's Primary Healthcare Initiative (PPHI)

Umarkot, Sindh, Pakistan

Location

MeSH Terms

Conditions

Severe Acute Malnutrition

Condition Hierarchy (Ancestors)

Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Associate Director

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: November 22, 2019
• Study Start: January 1, 2021
• Primary Completion: July 31, 2021
• Study Completion: October 31, 2021
• Last Updated: May 19, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)