An interventional study of WHO-reduced and WHO-full in Acute Malnutrition in Childhood, Acute Malnutrition, Severe and Acute Malnutrition, Moderate, sponsored by International Food Policy Research Institute. Not yet recruiting at 1 site in Kenya. Open to participants aged 6 Months to 59 Months. Per ClinicalTrials.gov, last updated 2026-02-19.
Sponsored by International Food Policy Research Institute · Not applicable, Interventional, and Treatment
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.
82 studies on the registry are indexed under Severe Acute Malnutrition; 13 are open to participants now.
This study's planned enrollment of 2,274 is above the median of 400 across 69 interventional studies indexed under Severe Acute Malnutrition.
Browse Severe Acute Malnutrition studies →International Food Policy Research Institute is the lead sponsor of 37 studies on the registry; 4 are open to participants now.
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Child admitted to the national treatment program according to the following criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
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HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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-reduced
Children will receive the continuous full, weight-based dosage of 150-185 kcal/kg/day until recovery. Visits will be weekly until recovery.
Other: WHO-full
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.
Other: Kenya-IMAM
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.
Children will receive the continuous full, weight-based dosage of 150-185 kcal/kg/day until recovery. Visits will be weekly until recovery.
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.
Anthropometric recovery
The number of discharges considered cured (WHZ ≥ -2 and MUAC ≥ 125 mm and absence of bilateral edema for two consecutive visits, within 12 weeks of enrollment in the program) divided by the total number of discharges recorded.
Time frame: Within 12 weeks of enrollment in the treatment program
Non-response
the number of children who failed to meet recovery criteria after 4 months in the program, divided by the total number of children admitted into treatment
Time frame: Within 12 weeks of enrollment in the treatment program
Transfer
the number of children transferred to inpatient care or outpatient therapeutic care during the course of treatment, divided by the total number of children admitted into treatment
Time frame: within 12 weeks of enrollment into the treatment program
Default rate
the number of children who were absent from three consecutive weekly visits during treatment, divided by the total number of children admitted into treatment
Time frame: Within 12 weeks of enrollment into the treatment program
Relapse
admission for a new episode of either MAM or SAM within 2 months of recovery from a previous episode.
Time frame: Within 2 months of recovery from a previous episode
Weight gain velocity
grams per kilogram of body weight per day gained during treatment
Time frame: Between enrollment into the treatment program and discharge (which is up to 12 weeks after enrollment into the treatment program)
Length of stay
number of days spent on treatment (days between admission and discharge) among children who reached anthropometric recovery
Time frame: between enrollment into the program and discharge (within 12 weeks of enrollment into the program)
Treatment adherence
the number of children enrolled for treatment who attended all study visits (i.e., who did not miss any visits) divided by the number of children admitted into treatment, among children who reached anthropometric recovery
Time frame: within 12 weeks of enrollment into the treatment program
Weight at discharge
Weight at the time of discharge from treatment
Time frame: At discharge (within 12 weeks of enrollment into the treatment program
Length/height at discharge
Length/height at the time of discharge from treatment
Time frame: At discharge (within 12 weeks of enrollment into the treatment program)
Weight-for-length/height-zscore at discharge
Weight-for-length/height-zscore at the time of discharge from treatment
Time frame: At discharge (within 12 weeks of enrollment into the treatment program)
Middle upper arm circumference at discharge
Middle upper arm circumference at the time of discharge from treatment
Time frame: At discharge (within 12 weeks of enrollment into the treatment program)
Length/height-for-age z-score at discharge
Length/height-for-age z-score at the time of discharge from treatment
Time frame: At discharge (within 12 weeks of enrollment into the treatment program)
Change in length/height at discharge
Change in length/height between enrollment and the time of discharge from treatment
Time frame: Between enrollment into the program and at discharge, which is up to 12 weeks within enrollment into the program
Weight-for-age z-score at discharge
Weight-for-age z-score at the time of discharge from treatment
Time frame: At discharge (within 12 weeks of enrollment into the treatment program)
Change in weight at discharge
Change in weight between enrollment into the program and at discharge, which is up to 12 weeks within enrollment into the program
Time frame: Between enrollment into the program and at discharge, which is up to 12 weeks within enrollment into the program
Change in weight-for-length/height z-score at discharge
Change in weight-for-length/height-zscore between enrollment into the program and at discharge, which is up to 12 weeks within enrollment into the program
Time frame: Between enrollment into the program and at discharge, which is up to 12 weeks within enrollment into the program
Change in middle upper arm circumference at discharge
Change in middle upper arm circumference between enrollment into the program and at discharge, which is up to 12 weeks within enrollment into the program
Time frame: Between enrollment into the program and at discharge, which is up to 12 weeks within enrollment into the program
Change in length/height-for-age z-score at discharge
Change in length/height-for-age z-score between enrollment into the program and at discharge, which is up to 12 weeks within enrollment into the program
Time frame: Between enrollment into the program and at discharge, which is up to 12 weeks within enrollment into the program
Change in weight-for-age z-score at discharge
Change in weight-for-age z-score between enrollment into the program and at discharge, which is up to 12 weeks within enrollment into the program
Time frame: Between enrollment into the program and at discharge, which is up to 12 weeks within enrollment into the program
Amount of product needed for recovery
number of sachets of RUTF or RUSF provided to children during the course of treatment among children who reached anthropometric recovery
Time frame: between enrollment into treatment and discharge (within 12 weeks of enrollment into the treatment program)
Mortality
the number of children who died during the treatment course, divided by the total number of children admitted into treatment
Time frame: between enrollment into treatment and discharge (within 12 weeks of enrollment into the treatment program)
Plan to share: Yes — All data will be fully anonymized and de-identified. No names, GPS coordinates, dates of birth or other identifying data will be stored in the databases. At the time of publication of scientific articles presenting primary results, the fully anonymized databases will become a public good and will be made available to the scientific community, government, and partners.
Supporting information: Study protocol, Statistical analysis plan
Time frame: At the time of publication of scientific articles presenting primary results.
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This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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International Food Policy Research Institute