Clinical trial NCT05248516: ComPAS Low-WAZ RCT Mali
Official title: Simplified Treatment of Children With Low WAZ in Mali. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Acute Malnutrition in Infancy
Acute Malnutrition in Childhood
Underweight
Keywords: wasting
stunting
underweight
malnutrition
ready-to-use therapeutic food
acute malnutrition
randomized controlled trial
weight-for-age z-score
mid-upper-arm circumference
Mali
Lead sponsor: International Rescue Committee
Sponsor class: OTHER
Collaborators: name: University of the Sciences, Techniques and Technologies of Bamako
name: Ministry of health, Mali
First posted: 2022-02-21
Enrollment: 1500
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Admissions criteria which treat children with only low mid-upper arm circumference (MUAC) or children with low weight-for-height z-score (WHZ) are not aligned with the evidence on which children are at risk of mortality. An analysis of community-based cohort data from Senegal found that a combination of weight-for-age z-score (WAZ) and MUAC criteria identified all children at risk of near-term death associated with severe anthropometric deficits. This finding has led to the suggestion that WAZ\<-3 could be added as an independent admissions criterion for therapeutic feeding programs currently admitting children with MUAC\<125 mm. However, there is little evidence to inform the debate about whether children with MUAC ≥125 mm and WAZ\<-3 would benefit from treatment and, if so, what treatment protocol should be used.

This study will address whether children with WAZ \<-3 but MUAC ≥125 mm benefit from therapeutic feeding and whether a simplified protocol is at least as effective as the more complicated weight-based standard protocol for this population.

The study will be a prospective, multi-center, individually randomized controlled trial (RCT). Children aged 6-59 months presenting with MUAC ≥125 mm and WAZ\<-3 will be randomized to one of three study arms.

The primary objective of this study is to assess whether therapeutic feeding with a simplified protocol (1 sachet RUTF/day) results in superior nutritional outcomes compared to no therapeutic feeding AND non-inferior nutritional outcomes compared to the WHZ and weight based dosing regimen currently used in CMAM treatment 2 months after diagnosis among children aged 6-59 months with MUAC ≥125 mm and WAZ\<-3 .

The primary outcome is the mean WAZ of children. Secondary outcomes include a) proportion of children with WAZ \<-3, b) mean MUAC of children, c) proportion of children with MUAC \< 125 mm, d) mean WHZ, mean HAZ, e) proportion of children with WHZ\<-3 or HAZ\<-3, f) change in WAZ, MUAC, WHZ, HAZ from enrolment to endpoint g) mean skinfold thickness measure.


Eligibility criteria: Inclusion Criteria:

* Age between 6 and 59 months
* MUAC ≥125 mm
* WAZ \<-3
* Living in the study catchment area
* Expects to be able to continue follow-up visits for next 6 months

Exclusion Criteria:

* nutritional edema
* Known peanut or milk allergy
* Severe illnesses requiring inpatient level treatment (according to IMCI guidelines)
* Medical condition affecting food intake (lip and palate cleft, handicap etc.)
* Has already taken part in the study

Primary outcomes:
measure: weight-for-age z-score (WAZ)
timeFrame: 2 months after enrolment
Secondary outcomes:
measure: weight-for-age z-score (WAZ)
timeFrame: 6 months after enrolment
measure: weight-for-age z-score (WAZ) <-3
timeFrame: both at 2 and 6 months post-enrolment
measure: weight-for-height z-score (WHZ)
timeFrame: both at 2 and 6 months post-enrolment
measure: weight-for-height z-score (WHZ) <-3
timeFrame: both at 2 and 6 months post-enrolment
measure: height-for-age z-score (HAZ)
timeFrame: both at 2 and 6 months post-enrolment
measure: height-for-age z-score (HAZ) <-3
timeFrame: both at 2 and 6 months post-enrolment
measure: Mid-upper-arm circumference (MUAC)
timeFrame: both at 2 and 6 months post-enrolment
Other outcomes:
measure: subscapular skin-fold thickness in millimeters
timeFrame: 2 and 6 months post-enrolment
measure: proportion having developed a mid-upper-arm circumference <125mm
timeFrame: 6 months post-enrolment
measure: tricep skin-fold thickness in millimeters
timeFrame: 2 and 6 months post-enrolment
measure: fat-free mass in kg
timeFrame: 2 and 6 months post-enrolment
measure: fat mass in kg
timeFrame: 2 and 6 months post-enrolment
measure: fat-free mass index in kg/m2
timeFrame: 2 and 6 months post-enrolment
measure: fat mass index in kg/m2
timeFrame: 2 and 6 months post-enrolment
measure: hemoglobin (g/l)
timeFrame: 2 and 6 months
measure: anaemia
timeFrame: 2 and 6 months
Locations:
city: Nara
country: Mali
facility: Dilly
state: Koulikoro
city: Nara
country: Mali
facility: Gassambarou
state: Koulikoro
city: Nara
country: Mali
facility: Goumbou
state: Koulikoro
city: Nara
country: Mali
facility: Kaloumba
state: Koulikoro
city: Nara
country: Mali
facility: Karfabougou
state: Koulikoro
city: Nara
country: Mali
facility: Koira
state: Koulikoro
city: Nara
country: Mali
facility: Koronga
state: Koulikoro
city: Nara
country: Mali
facility: Madina-Kagoro
state: Koulikoro
city: Nara
country: Mali
facility: Nara Central
state: Koulikoro
city: Nara
country: Mali
facility: Sampaga
state: Koulikoro
city: Nara
country: Mali
facility: Tiapato
state: Koulikoro
Study officials:
References: