NCT07420062

Reduced Dosage and/or Visitation Protocol for the Treatment of Acute Malnutrition in Kenya

Research to Improve the Screening for Wasting and the Identification and Treatment of Wasted Children (R-SWITCH): Reduced Dosage and/or Visitation Protocol for the Treatment of Severe Acute Malnutrition in Kenya

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,274 (estimated)
• Sponsor: International Food Policy Research Institute · Academic / Other
• Sex: All
• Age: 6 Months – 59 Months
• Healthy volunteers: Not accepted

Summary

Severe acute malnutrition (SAM) places children at significant risk of mortality. Outpatient treatment programs are effective but there is a need to increase treatment coverage and reduce costs of treatment. Reducing the dosage of therapeutic food products and/or reducing visitation required by caregivers may be beneficial but evidence is limited on the treatment outcomes and costs of these approaches. This study will compare two dosage options (full vs reduced dosages) of the World Health Organization protocol for the treatment of SAM and high-risk moderate acute malnutrition (HR-MAM) to each other and to the Kenya national protocol (which involves reducing dosage, changing treatment product, and reducing visitation schedule during the course of the treatment once the SAM child reaches the criteria for moderate acute malnutrition before recovery), in terms of treatment performance and cost. We will conduct a cluster-randomized controlled trial including 45 facilities in Samburu, West Pokot, and Wajir sub-counties. Children 6-59 months old being admitted into outpatient treatment programs for SAM or HR-MAM will be enrolled. Outcomes will be recovery, default, death, transfer, and non-response rates; treatment adherence; mean amount of therapeutic products needed for recovery; mean length of stay; and anthropometry at discharge. We will conduct a costing study in which we will estimate the costs per child admitted into treatment and cost per treated child recovered. We will estimate the non-inferiority of each of the two WHO protocol dosage options (full vs reduced) compared to the Kenya national protocol, and of the two WHO protocol options compared to each other (full vs reduced). Enrollment will begin in early 2026, and continue for 10 months. We will also conduct an observational sub-study documenting outcomes on children with MAM but who are not considered high risk in a sub-set of study facilities. Evidence generated from the study will identify the optimal treatment strategy for better treatment performance and lower cost, providing policymakers in Kenya and across the globe with high-quality evidence to inform policy change.

Conditions

• Acute Malnutrition in Childhood
• Acute Malnutrition, Severe
• Acute Malnutrition, Moderate
• Wasting

Interventions

Type	Name	Description
OTHER	WHO-reduced	Children will receive the full, weight-based dosage of RUTF (150-185 kcal/kg/day) until the resolution of severe wasting, followed by a shift to reduced dosage (100-130 kcal/kg/day) until recovery. Treatment visits will be weekly until recovery.
OTHER	WHO-full	Children will receive the continuous full, weight-based dosage of 150-185 kcal/kg/day until recovery. Visits will be weekly until recovery.
OTHER	Kenya-IMAM	Children will receive the Kenya Integrated Management of Acute Malnutrition protocol for treatment. In this protocol, children will receive the weight-based dosing RUTF during treatment while they meet the SAM criteria (150-185 kcal/kg/day) and then 1 sachet RUSF for SAM children meeting the MAM criteria on the recovery period. Visits will be weekly during the SAM phase, and bi-weekly during the MAM phase.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-03-01
• Completion: 2027-05-01
• First posted: 2026-02-19
• Last updated: 2026-02-19

Locations

1 site across 1 country: Kenya