Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05248516
Other study ID # H 1.00.033
Secondary ID
Status Active, not recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date September 1, 2022
Est. completion date April 30, 2024

Study information

Verified date January 2024
Source International Rescue Committee
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1500
Est. completion date April 30, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 6 Months to 59 Months
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Mali 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

Sponsors (3)

Lead Sponsor Collaborator
International Rescue Committee Ministry of health, Mali, University of the Sciences, Techniques and Technologies of Bamako

Country where clinical trial is conducted

Mali, 

Outcome

Type Measure Description Time frame Safety issue
Other subscapular skin-fold thickness in millimeters 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. 2 and 6 months post-enrolment
Other proportion having developed a mid-upper-arm circumference <125mm 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. 6 months post-enrolment
Other tricep skin-fold thickness in millimeters 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. 2 and 6 months post-enrolment
Other fat-free mass in kg 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. 2 and 6 months post-enrolment
Other fat mass in kg 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. 2 and 6 months post-enrolment
Other fat-free mass index in kg/m2 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. 2 and 6 months post-enrolment
Other fat mass index in kg/m2 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. 2 and 6 months post-enrolment
Other hemoglobin (g/l) this is a continuous outcome and will be obtained through HemoCue measurement of peripheral blood 2 and 6 months
Other anaemia this is a binary outcome and will be obtained through hemoglobin measurement of peripheral blood and categorising Hb<11g/l as anaemic. 2 and 6 months
Primary 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 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. 6 months after enrolment
Secondary 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. both at 2 and 6 months post-enrolment
Secondary 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. both at 2 and 6 months post-enrolment
Secondary 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. both at 2 and 6 months post-enrolment
Secondary 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. both at 2 and 6 months post-enrolment
Secondary 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. both at 2 and 6 months post-enrolment
Secondary 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. both at 2 and 6 months post-enrolment
See also
  Status Clinical Trial Phase
Completed NCT02451410 - An Intervention to Improve Nutrition and Physical Activity in Preschoolers in Cuenca, Ecuador N/A
Completed NCT05517395 - The Effectiveness of HBM-based Education Program on Improve Knowledge and Behaviors N/A
Completed NCT04561635 - Effects of Multiple-micronutrients Supplementation on Growth and Iron Status of Indigenous Children in Malaysia N/A
Recruiting NCT03398343 - Nutritional Therapy on Underweight Critically Ill Patients: an Observational Study N/A
Completed NCT01553552 - Schistosomiasis Effect on Response to Vaccines, Anaemia and Nutritional Status of Children of Northern Senegal N/A
Completed NCT05574842 - The Effect of Double Duty Interventions on Double Burden of Malnutrition Among School Adolescents in Ethiopia N/A
Completed NCT05077059 - Prevalence of Obesity and Overweight in Primary School Children in the Rhein-Neckar Region in Germany
Completed NCT03847662 - Scaling up Small-Scale Food Processing to Promote Food Security Among Women Farmers in Rural Vietnam
Completed NCT03378141 - Maternal Nutrition Interventions in Uttar Pradesh, India N/A
Completed NCT05346549 - Energy Regulation and Nutritional Status of Children: A Satiation Study N/A
Recruiting NCT05793294 - Child Health, Nutrition and Microbiome Development
Completed NCT04851327 - Satiation Study With Children Attending a Tertiary Feeding Clinic N/A
Completed NCT04848129 - Genetic Correlates of Wasting: a Pilot Study With Children Attending a Tertiary Feeding Clinic
Completed NCT03523182 - Spirulina Supplementation and Infant Growth, Morbidity and Motor Development N/A
Recruiting NCT05881447 - Prevalence, Incidence and Risk Signature of Chronic Kidney Disease in Sub-Saharan Africa
Completed NCT04631978 - Analysis of Retinochoroidal Vasculature in Underweight Women Using Optical Coherence Tomography Angiography
Active, not recruiting NCT05952076 - Impact of Bi-26 Supplementation on Weight Gain in Underweight Infants Phase 3
Not yet recruiting NCT06309576 - Experimental Approach to Test Predictions of Body Weight Regulation Models N/A
Not yet recruiting NCT05457712 - Nutrition In Preoperative Pediatric Congenital Heart Disease N/A
Active, not recruiting NCT03638557 - School Lunch Program (SLP) Towards Nutrition Knowledge, Attitude, Practices and Nutrition Status of Adolescents N/A