Acute Malnutrition in Childhood, Acute Malnutrition in Infancy, Underweight
Conditions
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
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.
Interventions
DIETARY_SUPPLEMENTSimplified 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_SUPPLEMENTStandard 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_SUPPLEMENTNo nutritional treatment
no nutritional treatment will be provided to children in the control arm.
Sponsors
University of the Sciences, Techniques and Technologies of Bamako
Ministry of health, Mali
International Rescue Committee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 59 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| weight-for-age z-score (WAZ) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| weight-for-age z-score (WAZ) <-3 | both at 2 and 6 months post-enrolment | 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) | both at 2 and 6 months post-enrolment | 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 | both at 2 and 6 months post-enrolment | 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. |
| weight-for-age z-score (WAZ) | 6 months after enrolment | 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. |
| height-for-age z-score (HAZ) <-3 | both at 2 and 6 months post-enrolment | 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) | both at 2 and 6 months post-enrolment | 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. |
| height-for-age z-score (HAZ) | both at 2 and 6 months post-enrolment | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| subscapular skin-fold thickness in millimeters | 2 and 6 months post-enrolment | 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. |
| anaemia | 2 and 6 months | this is a binary outcome and will be obtained through hemoglobin measurement of peripheral blood and categorising Hb\<11g/l as anaemic. |
| proportion having developed a mid-upper-arm circumference <125mm | 6 months post-enrolment | 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. |
| tricep skin-fold thickness in millimeters | 2 and 6 months post-enrolment | 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. |
| fat-free mass in kg | 2 and 6 months post-enrolment | 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. |
| fat mass in kg | 2 and 6 months post-enrolment | 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. |
| fat-free mass index in kg/m2 | 2 and 6 months post-enrolment | 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. |
| fat mass index in kg/m2 | 2 and 6 months post-enrolment | 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. |
| hemoglobin (g/l) | 2 and 6 months | this is a continuous outcome and will be obtained through HemoCue measurement of peripheral blood |
Countries
Mali
Outcome results
None listed