Acute Malnutrition in InfancyPhase 2/3NCT05248516
ComPAS Low-WAZ RCT Mali
A Phase 2/3 study testing Simplified dose of ready-to-use therapeutic food (RUTF), Standard dose of ready-to-use therapeutic food (RUTF) and No nutritional treatment in people with Acute Malnutrition in Infancy and Acute Malnutrition in Childhood, run by International Rescue Committee at 11 sites in Mali.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Acute Malnutrition in Infancy, Acute Malnutrition in Childhood, Underweight
- What is being tested?
- Simplified dose of ready-to-use therapeutic food (RUTF), Standard dose of ready-to-use therapeutic food (RUTF) and No nutritional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 11 sitesMali
- Study dates
- 1 Sep 2022to 30 Apr 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Mali11 sites
Dilly
Nara, Koulikoro
Gassambarou
Nara, Koulikoro
Goumbou
Nara, Koulikoro
Kaloumba
Nara, Koulikoro
Karfabougou
Nara, Koulikoro
Koira
Nara, Koulikoro
Koronga
Nara, Koulikoro
Madina-Kagoro
Nara, Koulikoro
Nara Central
Nara, Koulikoro
Sampaga
Nara, Koulikoro
Tiapato
Nara, Koulikoro
About this study
Official title: Simplified Treatment of Children With Low WAZ in Mali. A Randomized Controlled Trial
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.
Read more
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.
- Being tested
- Simplified dose of ready-to-use therapeutic food (RUTF), Standard dose of ready-to-use therapeutic food (RUTF), No nutritional treatment
- 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
- Medical subject headings
- Thinness, Cachexia, Growth Disorders, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simplified dose of ready-to-use therapeutic food (RUTF)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 dose of ready-to-use therapeutic food (RUTF)Dietary supplement
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.
No nutritional treatmentDietary supplement
no nutritional treatment will be provided to children in the control arm.
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | no nutritional treatment administered Receives: Dietary Supplement: No nutritional treatment |
| Simplified treatment | Experimental | children are provided with 1 sachet of RUTF until discharge Receives: Dietary Supplement: Simplified dose of ready-to-use therapeutic food (RUTF) |
| Standard treatment | Active comparator | 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 Receives: Dietary Supplement: Standard dose of ready-to-use therapeutic food (RUTF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months after enrolment
Secondary outcomes (7)
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.
Measured: 6 months after enrolment
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.
Measured: both at 2 and 6 months post-enrolment
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.
Measured: both at 2 and 6 months post-enrolment
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.
Measured: both at 2 and 6 months post-enrolment
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.
Measured: both at 2 and 6 months post-enrolment
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.
Measured: both at 2 and 6 months post-enrolment
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.
Measured: both at 2 and 6 months post-enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start1 Sep 2022
- Primary completion31 Dec 2023
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Malnutrition in InfancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Rescue Committee
- Sponsor type
- University, hospital or other
- Collaborators
- University of the Sciences, Techniques and Technologies of Bamako, Ministry of health, Mali
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05248516
- Sponsor's protocol ID
- H 1.00.033
- Status last verified
- Jan 2024
- First submitted
- 27 Jan 2022
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 38191436
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simplified Treatment of Children With Low WAZ in Mali. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05248516
- Acronym / sponsor ID
- H 1.00.033
- Keywords
- wasting, stunting, underweight, malnutrition, ready-to-use therapeutic food, acute malnutrition, randomized controlled trial, weight-for-age z-score
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- International Rescue CommitteeUniversity, hospital or other
- Collaborators
- University of the Sciences, Techniques and Technologies of Bamako, Ministry of health, Mali
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 21 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Dietary Supplement: No nutritional treatmentno nutritional treatment administered |
| Simplified treatment | Experimental | Dietary Supplement: Simplified dose of ready-to-use therapeutic food (RUTF)children are provided with 1 sachet of RUTF until discharge |
| Standard treatment | Active comparator | Dietary Supplement: Standard dose of ready-to-use therapeutic food (RUTF)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 |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Simplified treatment |
| 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. | Dietary supplement | Standard treatment |
| No nutritional treatmentno nutritional treatment will be provided to children in the control arm. | Dietary supplement | Control |
Primary outcome
weight-for-age z-score (WAZ)
Time frame: 2 months after enrolment
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.
7 secondary outcomes
weight-for-age z-score (WAZ)
Time frame: 6 months after enrolment
weight-for-age z-score (WAZ) <-3
Time frame: both at 2 and 6 months post-enrolment
weight-for-height z-score (WHZ)
Time frame: both at 2 and 6 months post-enrolment
weight-for-height z-score (WHZ) <-3
Time frame: both at 2 and 6 months post-enrolment
height-for-age z-score (HAZ)
Time frame: both at 2 and 6 months post-enrolment
height-for-age z-score (HAZ) <-3
Time frame: both at 2 and 6 months post-enrolment
Mid-upper-arm circumference (MUAC)
Time frame: both at 2 and 6 months post-enrolment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Derived from this study: PubMed 38191436Kangas 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.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Simplified dose of ready-to-use therapeutic food (RUTF), Standard dose of ready-to-use therapeutic food (RUTF) and No nutritional treatment in people with Acute Malnutrition in Infancy and Acute Malnutrition in Childhood, run by International Rescue Committee at 11 sites in Mali.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Mali. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight-for-age z-score (WAZ) (time frame: 2 months after enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05248516, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.