ComPAS Low-WAZ RCT Mali

NCT ID: NCT05248516

Last Updated: 2024-01-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 1500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2024-04-30

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.

Conditions

Acute Malnutrition in Infancy; Acute Malnutrition in Childhood; Underweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control

no nutritional treatment administered

Group Type: OTHER

No nutritional treatment

Intervention Type: DIETARY_SUPPLEMENT

no nutritional treatment will be provided to children in the control arm.

Simplified treatment

children are provided with 1 sachet of RUTF until discharge

Group Type: EXPERIMENTAL

Simplified dose of ready-to-use therapeutic food (RUTF)

Intervention Type: DIETARY_SUPPLEMENT

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.

Standard treatment

children 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

Group Type: ACTIVE_COMPARATOR

Standard dose of ready-to-use therapeutic food (RUTF)

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

Simplified dose of ready-to-use therapeutic food (RUTF)

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.

Intervention Type: DIETARY_SUPPLEMENT

Standard dose of ready-to-use therapeutic food (RUTF)

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.

Intervention Type: DIETARY_SUPPLEMENT

No nutritional treatment

no nutritional treatment will be provided to children in the control arm.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 59 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of the Sciences, Techniques and Technologies of Bamako

OTHER

Sponsor Role: collaborator

Ministry of health, Mali

UNKNOWN

Sponsor Role: collaborator

International Rescue Committee

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

Mali

References

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.

Reference Type: DERIVED

PMID: 38191436 (View on PubMed)

Other Identifiers

H 1.00.033

Identifier Type: -

Identifier Source: org_study_id