Choline to Prevent SAM in Children With MAM
- Conditions
- Interventions
- Registration Number
- NCT06214897
- Lead Sponsor
- Washington University School of Medicine
- Brief Summary
The goal of this clinical trial is to test choline supplementation in children with moderate acute malnutrition in Malawi. The main question it aims to answer is:
...
- Detailed Description
Moderate acute malnutrition (MAM) is common among children worldwide, with a prevalence of 50M and an annual incidence likely 3-5x this number. It is defined by mid-upper arm circumference (MUAC) ≥ 11.5 cm and \< 12.5 cm or weight-for-length (WLZ) z-score ≥ -3 and \< -2. MAM increases a child's risk of deterioration to severe acute malnutrition (SAM), stunti...
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1500
- 6-59 months of age
- uncomplicated MAM (mid-upper arm circumference (MUAC) ≥ 11.5 cm and < 12.5 cm and/or weight-for-length z-score (WLZ) ≥ -3 and < -2)
- availability for the duration of the study with no plan to move from the catchment area of a participating clinic
- presence of nutritional edema
- features of complicated MAM, such as mental status changes or breathing issues
- participation in another feeding program
- known allergy to study food ingredient
- intention to move away from catchment area within 9 months
- developmental delay
- presence of a chronic severe medical condition (other than TB or HIV) such as congenital heart disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description S-RUSF (Standard Ready-to-use Supplemental Food without added choline) S-RUSF (Ready-to-use Supplemental Food without added Choline) A daily dose of 500 Kcal of RUSF without choline C-RUSF (Ready-to-use Supplemental Food with added choline) C-RUSF (Ready-to-use Supplemental Food with added Choline) A daily dose of 500 Kcal of RUSF containing 500mg choline will be provided
- Primary Outcome Measures
Name Time Method Percentage of pairwise comparisons with wins of Clinical Benefit, which is a composite of time-to-SAM, graduation, and rate of weight change between enrollment and 4-week follow-up. 2-12 weeks of supplementary feeding Clinical benefit is defined as a composite of time-to-SAM, graduation, and rate of weight change. Each participant randomized to C-RUSF is compared to each participant randomized to S-RUSF. For any two participants, a participant will win, i.e. achieve a better clinical outcome, as determined by assessing the following criteria sequentially, stopping when an...
- Secondary Outcome Measures
Name Time Method Deterioration to SAM 2-12 weeks of supplementary feeding Children who meet any criteria for SAM during MAM treatment will be considered to have deteriorated to SAM. These are:
* mid-upper arm circumference (MUAC) \< 11.5 cm
* weight-for-length z-score (WLZ) \< -3
* Presence of bilateral pitting edemaMalawi Developmental Assessment Tool global z-score Within 4 weeks of MAM outcome Age-standardized score, -6 to +6, higher scores are better
Rate of length change 2-12 weeks of supplementary feeding (until MAM outcome) mm/week
Malawi Developmental Assessment Tool fine motor sub-domain z-score Within 4 weeks of MAM outcome Age-standardized score, -6 to +6, higher scores are better
Malawi Developmental Assessment Tool social sub-domain z-score Within 4 weeks of MAM outcome Age-standardized score, -6 to +6, higher scores are better
Diarrhea 2-12 weeks of supplementary feeding (until MAM outcome) Days, reported by caregiver, safety outcome
Graduation 2-12 weeks of supplementary feeding Based on the criteria by which the participant was diagnosed with MAM:
* If a child qualifies for the study based on MUAC \< 12.5 cm, the child must obtain MUAC ≥ 12.5 cm.
* If a child qualifies for the study based on WLZ \< -2, the child must obtain WLZ ≥ -2.
...Death From enrollment to end of participant's engagement (at latest, time of 6-month post-outcome MDAT testing) Defined by caregiver report
Rate of mid-upper arm circumference (MUAC) change Across first 4 weeks of supplementary feeding mm/week
Change in MDAT global z-score From MDAT near time of MAM outcome to 6-month post-MAM-outcome MDAT visit Difference in MDAT global z-score between 6-month post-MAM outcome visit and MDAT global z-score measured within 4 weeks of MAM outcome, more positive scores are better
Deterioration to marasmus 2-12 weeks of supplementary feeding Development of MUAC \< 11.5 cm and/or WLZ \< -3
Malawi Developmental Assessment Tool gross motor sub-domain z-score Within 4 weeks of MAM outcome Age-standardized score, -6 to +6, higher scores are better
Rate of weight change Across first 4 weeks of supplementary feeding g/kg/day. Rate of weight gain is calculated as difference in weight in grams between the second follow-up visit (usually 4 weeks after enrollment) and the enrollment visit, divided by enrollment weight (kg), divided by the time between the second follow-up visit and enrollment visit. If the participant lacks data beyond the first follow-up visit, this data w...
Deterioration to kwashiorkor 2-12 weeks of supplementary feeding Development of nutritional edema (bilateral pedal pitting edema)
Docosahexaenoic acid (DHA) status 2-12 weeks of supplementary feeding (at time of MAM outcome) DHA as % of serum fatty acids
Malawi Developmental Assessment Tool language sub-domain z-score Within 4 weeks of MAM outcome Age-standardized score, -6 to +6, higher scores are better
Proportion of participations requiring hospitalization 2-12 weeks of supplementary feeding (until MAM outcome) Safety outcome
Trial Locations
- Locations (10)
Makhwira Health Center
🇲🇼Makhwira, Malawi
Mitondo Health Center
🇲🇼Mitondo, Malawi
Namasalima Health Center
🇲🇼Namasalima, Malawi
Chipolonga Health Center
🇲🇼Chipolonga, Malawi
Nkhate Health Clinic
🇲🇼Nkhate, Malawi
Chikonde Health Center
🇲🇼Chikonde, Malawi
Mbiza Health Clinic
🇲🇼Mbiza, Malawi
Milonde Health Center
🇲🇼Milonde, Malawi
Muloza Health Clinic
🇲🇼Muloza, Malawi
Naphimba Health Center
🇲🇼Naphimba, Malawi