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ComPAS Low-WAZ RCT Mali

Primary Purpose

Acute Malnutrition in Infancy, Acute Malnutrition in Childhood, Underweight

Status
Recruiting
Phase
Phase 2
Locations
Mali
Study Type
Interventional
Intervention
Simplified dose of ready-to-use therapeutic food (RUTF)
Standard dose of ready-to-use therapeutic food (RUTF)
No nutritional treatment
Sponsored by
International Rescue Committee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Malnutrition in Infancy focused on measuring wasting, stunting, underweight, malnutrition, ready-to-use therapeutic food, acute malnutrition, randomized controlled trial, weight-for-age z-score, mid-upper-arm circumference, Mali

Eligibility Criteria

6 Months - 59 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • DillyRecruiting
  • GassambarouRecruiting
  • GoumbouRecruiting
  • KaloumbaRecruiting
  • KarfabougouRecruiting
  • KoiraRecruiting
  • KorongaRecruiting
  • Madina-KagoroRecruiting
  • Nara CentralRecruiting
  • SampagaRecruiting
  • TiapatoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

Active Comparator

Arm Label

Control

Simplified treatment

Standard treatment

Arm Description

no nutritional treatment administered

children are provided with 1 sachet of RUTF until discharge

children are provided nutritional treatment according to their weight-for-height z-score (WHZ) and their weight: children with a WHZ<-3 will receive 200kcal/kg/d of nutritional product until discharge children with a WHZ between -3 and -2 are provided with 1 sachet of RUTF until discharge children with a WHZ >= -2 will not be provided any nutritional treatment

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

weight-for-age z-score (WAZ)
the secondary outcome is a continuous outcome: a higher WAZ indicates 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.
weight-for-age z-score (WAZ) <-3
this outcome is binary: a higher proportion of WAZ<-3 indicates a negative 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.
weight-for-height z-score (WHZ)
this outcome is a continuous outcome: a higher WHZ indicates a positive outcome. To construct WHZ at any point in time, children's height and weight will be measured at each time point: height with 0.1cm precision and weight with 0.1kg precision. WHZ will be calculated using zscore06 fonction in STATA that is based on the WHO growth reference data specific to each gender.
weight-for-height z-score (WHZ) <-3
this outcome is binary: a higher proportion of WHZ<-3 indicates a negative outcome. To construct WHZ at any point in time, children's height and weight will be measured at each time point: height with 0.1cm precision and weight with 0.1kg precision. WHZ will be calculated using zscore06 fonction in STATA that is based on the WHO growth reference data specific to each gender.
height-for-age z-score (HAZ)
this outcome is a continuous outcome: a higher HAZ indicates a positive outcome. To construct HAZ at any point in time, children's age will be calculated based on their age at admission and their height will be measured at each time point with 0.1cm precision. HAZ will be calculated using zscore06 fonction in STATA that is based on the WHO growth reference data specific to each gender.
height-for-age z-score (HAZ) <-3
this outcome is binary: a higher proportion of HAZ<-3 indicates a negative outcome. To construct HAZ at any point in time, children's age will be calculated based on their age at admission and their height will be measured at each time point with 0.1cm precision. HAZ will be calculated using zscore06 fonction in STATA that is based on the WHO growth reference data specific to each gender.
Mid-upper-arm circumference (MUAC)
this outcome is a continuous outcome: a higher MUAC indicates a positive outcome. MUAC will be measured using a while MUAC tape with a precision of 1mm.

Full Information

First Posted
January 27, 2022
Last Updated
September 5, 2022
Sponsor
International Rescue Committee
Collaborators
University of the Sciences, Techniques and Technologies of Bamako, Ministry of health, Mali
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1. Study Identification

Unique Protocol Identification Number
NCT05248516
Brief Title
ComPAS Low-WAZ RCT Mali
Official Title
Simplified Treatment of Children With Low WAZ in Mali. A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International Rescue Committee
Collaborators
University of the Sciences, Techniques and Technologies of Bamako, Ministry of health, Mali

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm Description
no nutritional treatment administered
Arm Title
Simplified treatment
Arm Type
Experimental
Arm Description
children are provided with 1 sachet of RUTF until discharge
Arm Title
Standard treatment
Arm Type
Active Comparator
Arm Description
children are provided nutritional treatment according to their weight-for-height z-score (WHZ) and their weight: children with a WHZ<-3 will receive 200kcal/kg/d of nutritional product until discharge children with a WHZ between -3 and -2 are provided with 1 sachet of RUTF until discharge children with a WHZ >= -2 will not be provided any nutritional treatment
Intervention Type
Dietary Supplement
Intervention Name(s)
Simplified dose of ready-to-use therapeutic food (RUTF)
Intervention Description
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
Intervention Name(s)
Standard dose of ready-to-use therapeutic food (RUTF)
Intervention Description
In the standard arm, children will receive different doses of RUTF depending on their WHZ category and weight. children with a WHZ<-3 will receive the equivalent of 200kcal/kg/d of RUTF until discharge. children with a WHZ between -3 and -2 will receive 1 sachet (500kcal) of RUTF per day until discharge. 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
Intervention Name(s)
No nutritional treatment
Intervention Description
no nutritional treatment will be provided to children in the control arm.
Primary Outcome Measure Information:
Title
weight-for-age z-score (WAZ)
Description
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.
Time Frame
2 months after enrolment
Secondary Outcome Measure Information:
Title
weight-for-age z-score (WAZ)
Description
the secondary outcome is a continuous outcome: a higher WAZ indicates 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.
Time Frame
6 months after enrolment
Title
weight-for-age z-score (WAZ) <-3
Description
this outcome is binary: a higher proportion of WAZ<-3 indicates a negative 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.
Time Frame
both at 2 and 6 months post-enrolment
Title
weight-for-height z-score (WHZ)
Description
this outcome is a continuous outcome: a higher WHZ indicates a positive outcome. To construct WHZ at any point in time, children's height and weight will be measured at each time point: height with 0.1cm precision and weight with 0.1kg precision. WHZ will be calculated using zscore06 fonction in STATA that is based on the WHO growth reference data specific to each gender.
Time Frame
both at 2 and 6 months post-enrolment
Title
weight-for-height z-score (WHZ) <-3
Description
this outcome is binary: a higher proportion of WHZ<-3 indicates a negative outcome. To construct WHZ at any point in time, children's height and weight will be measured at each time point: height with 0.1cm precision and weight with 0.1kg precision. WHZ will be calculated using zscore06 fonction in STATA that is based on the WHO growth reference data specific to each gender.
Time Frame
both at 2 and 6 months post-enrolment
Title
height-for-age z-score (HAZ)
Description
this outcome is a continuous outcome: a higher HAZ indicates a positive outcome. To construct HAZ at any point in time, children's age will be calculated based on their age at admission and their height will be measured at each time point with 0.1cm precision. HAZ will be calculated using zscore06 fonction in STATA that is based on the WHO growth reference data specific to each gender.
Time Frame
both at 2 and 6 months post-enrolment
Title
height-for-age z-score (HAZ) <-3
Description
this outcome is binary: a higher proportion of HAZ<-3 indicates a negative outcome. To construct HAZ at any point in time, children's age will be calculated based on their age at admission and their height will be measured at each time point with 0.1cm precision. HAZ will be calculated using zscore06 fonction in STATA that is based on the WHO growth reference data specific to each gender.
Time Frame
both at 2 and 6 months post-enrolment
Title
Mid-upper-arm circumference (MUAC)
Description
this outcome is a continuous outcome: a higher MUAC indicates a positive outcome. MUAC will be measured using a while MUAC tape with a precision of 1mm.
Time Frame
both at 2 and 6 months post-enrolment
Other Pre-specified Outcome Measures:
Title
subscapular skin-fold thickness in millimeters
Description
this outcome is a continuous outcome. there are currently no internationally accepted standards for the skinfold measure of young children. we will thus report the mean and any other relevant data on this and discuss the results in light of past research.
Time Frame
2 and 6 months post-enrolment
Title
proportion having developed a mid-upper-arm circumference <125mm
Description
the proportion of children that exit the study with a MUAC<125mm at any point in time will be estimated. MUAC will be measured at each visit using a while MUAC tape with a precision of 1mm.
Time Frame
6 months post-enrolment
Title
tricep skin-fold thickness in millimeters
Description
this outcome is a continuous outcome. there are currently no internationally accepted standards for the skinfold measure of young children. we will thus report the mean and any other relevant data on this and discuss the results in light of past research.
Time Frame
2 and 6 months post-enrolment
Title
fat-free mass in kg
Description
this outcome is a continuous outcome obtained through bioelectrical impedance analysis and applying a suitable equation to obtain fat-free mass estimations from weight and impedance.
Time Frame
2 and 6 months post-enrolment
Title
fat mass in kg
Description
this outcome is a continuous outcome obtained through bioelectrical impedance analysis and applying a suitable equation to first obtain fat-free mass estimations from weight and impedance and then by substracting fat-free mass from weight.
Time Frame
2 and 6 months post-enrolment
Title
fat-free mass index in kg/m2
Description
this outcome is a continuous outcome obtained through bioelectrical impedance analysis and applying a suitable equation to obtain fat-free mass estimations from weight and impedance and indexing fat-free mass to height squared to adjust for differences in size.
Time Frame
2 and 6 months post-enrolment
Title
fat mass index in kg/m2
Description
this outcome is a continuous outcome obtained through bioelectrical impedance analysis and applying a suitable equation to first obtain fat-free mass estimations from impedance and weight and then substracting fat-free mass from weight and indexing the obtained fat mass to height squared to adjust for differences in size.
Time Frame
2 and 6 months post-enrolment
Title
hemoglobin (g/l)
Description
this is a continuous outcome and will be obtained through HemoCue measurement of peripheral blood
Time Frame
2 and 6 months
Title
anaemia
Description
this is a binary outcome and will be obtained through hemoglobin measurement of peripheral blood and categorising Hb<11g/l as anaemic.
Time Frame
2 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suvi T Kangas, MSc, PhD
Phone
+221 78 107 83 45
Email
suvi.kangas@rescue.org
First Name & Middle Initial & Last Name or Official Title & Degree
Césaire Ouedraogo, MD, PhD
Phone
+223 76 67 48 02
Email
cesaire.ouedraogo@rescue.org
Facility Information:
Facility Name
Dilly
City
Nara
State/Province
Koulikoro
Country
Mali
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niakale Dembele
Phone
+223 76 80 65 53
Facility Name
Gassambarou
City
Nara
State/Province
Koulikoro
Country
Mali
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nouhoum Diakite
Phone
+223 77 64 17 35
Facility Name
Goumbou
City
Nara
State/Province
Koulikoro
Country
Mali
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niakale Dembele
Phone
+223 76 80 65 53
Facility Name
Kaloumba
City
Nara
State/Province
Koulikoro
Country
Mali
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sidi Teme
Phone
+223 82 00 34 33
Facility Name
Karfabougou
City
Nara
State/Province
Koulikoro
Country
Mali
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sidi Teme
Phone
+223 82 00 34 33
Facility Name
Koira
City
Nara
State/Province
Koulikoro
Country
Mali
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sidi Teme
Phone
+223 82 00 34 33
Facility Name
Koronga
City
Nara
State/Province
Koulikoro
Country
Mali
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kadidia Traore
Phone
+223 73 95 27 68
Facility Name
Madina-Kagoro
City
Nara
State/Province
Koulikoro
Country
Mali
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sidi Teme
Phone
+223 82 00 34 33
Facility Name
Nara Central
City
Nara
State/Province
Koulikoro
Country
Mali
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kadidia Traore
Phone
+223 73 95 27 68
Facility Name
Sampaga
City
Nara
State/Province
Koulikoro
Country
Mali
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nouhoum Diakite
Phone
+223 77 64 17 35
Facility Name
Tiapato
City
Nara
State/Province
Koulikoro
Country
Mali
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nouhoum Diakite
Phone
+223 77 64 17 35

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing 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.

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ComPAS Low-WAZ RCT Mali

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