ComPAS Low-WAZ RCT Mali
Simplified Treatment of Children With Low WAZ in Mali. A Randomized Controlled Trial
1 other identifier
interventional
1,500
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2022
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2022
CompletedFirst Posted
Study publicly available on registry
February 21, 2022
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2024
CompletedJanuary 3, 2024
January 1, 2024
1.3 years
January 27, 2022
January 2, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
weight-for-age z-score (WAZ)
the primary outcome is a continuous outcome: a higher WAZ indicates of a positive outcome. To construct WAZ at any point in time, children's age will be calculated based on their age at admission and their weight will be measured at each time point with 0.1kg precision. WAZ will be calculated using zscore06 fonction in STATA that is based on the WHO growth reference data specific to each gender.
2 months after enrolment
Secondary Outcomes (7)
weight-for-age z-score (WAZ)
6 months after enrolment
weight-for-age z-score (WAZ) <-3
both at 2 and 6 months post-enrolment
weight-for-height z-score (WHZ)
both at 2 and 6 months post-enrolment
weight-for-height z-score (WHZ) <-3
both at 2 and 6 months post-enrolment
height-for-age z-score (HAZ)
both at 2 and 6 months post-enrolment
- +2 more secondary outcomes
Other Outcomes (9)
subscapular skin-fold thickness in millimeters
2 and 6 months post-enrolment
proportion having developed a mid-upper-arm circumference <125mm
6 months post-enrolment
tricep skin-fold thickness in millimeters
2 and 6 months post-enrolment
- +6 more other outcomes
Study Arms (3)
Control
OTHERno nutritional treatment administered
Simplified treatment
EXPERIMENTALchildren are provided with 1 sachet of RUTF until discharge
Standard treatment
ACTIVE COMPARATORchildren are provided nutritional treatment according to their weight-for-height z-score (WHZ) and their weight: 1. children with a WHZ\<-3 will receive 200kcal/kg/d of nutritional product until discharge 2. children with a WHZ between -3 and -2 are provided with 1 sachet of RUTF until discharge 3. children with a WHZ \>= -2 will not be provided any nutritional treatment
Interventions
In the simplified arm all children receive the same dose: 1 sachet of RUTF/day. This until discharge from treatment. Recovery from treatment will be defined as WAZ\>= -3 on 2 consecutive visits. A maximum of 12 treatment weeks are allowed before declaring non-response. Defaulting will be declared after 2 consecutively missed visits.
In the standard arm, children will receive different doses of RUTF depending on their WHZ category and weight. 1. children with a WHZ\<-3 will receive the equivalent of 200kcal/kg/d of RUTF until discharge. 2. children with a WHZ between -3 and -2 will receive 1 sachet (500kcal) of RUTF per day until discharge. 3. children with a WHZ\>=-2 will receive no nutritional treatment. Recovery from treatment will be defined as WHZ\>= -2 on 2 consecutive visits. A maximum of 12 treatment weeks are allowed before declaring non-response. Defaulting will be declared after 2 consecutively missed visits.
no nutritional treatment will be provided to children in the control arm.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Dilly
Nara, Koulikoro, Mali
Gassambarou
Nara, Koulikoro, Mali
Goumbou
Nara, Koulikoro, Mali
Kaloumba
Nara, Koulikoro, Mali
Karfabougou
Nara, Koulikoro, Mali
Koira
Nara, Koulikoro, Mali
Koronga
Nara, Koulikoro, Mali
Madina-Kagoro
Nara, Koulikoro, Mali
Nara Central
Nara, Koulikoro, Mali
Sampaga
Nara, Koulikoro, Mali
Tiapato
Nara, Koulikoro, Mali
Related Publications (1)
Kangas ST, Ouedraogo CT, Tounkara M, Ouoluoguem B, Coulibaly IN, Haidara A, Diarra NH, Diassana K, Tausanovitch Z, Ritz C, Wells JC, Briend A, Myatt M, Radin E, Bailey J. Nutritional treatment of children 6-59 months with severely low weight-for-age z-score: a study protocol for a 3-arm randomized controlled trial. Trials. 2024 Jan 8;25(1):30. doi: 10.1186/s13063-023-07890-0.
PMID: 38191436DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2022
First Posted
February 21, 2022
Study Start
September 1, 2022
Primary Completion
December 31, 2023
Study Completion
April 30, 2024
Last Updated
January 3, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Study protocol, SAP and ICF will be published with the main results. The SAP will also be made available through clinicaltrials.gov prior to trial data collection completion. The study data underlying the key findings will be made freely available once analysis is complete and results published for the primary and secondary objectives and outcomes.
- Access Criteria
- Study protocol, SAP and ICF will be openly available via the publication. The study data will be made freely available from Zenodo or similar data repository.
The investigators are planning on making data underlying publications available through on-line data repositories such as Zenodo. This data would be de-identified prior to sharing.