Choline to Prevent SAM in Children With MAM

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
Inclusion Criteria
  • 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
Read More
Exclusion Criteria
  • 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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
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
NameTimeMethod
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
NameTimeMethod
Deterioration to SAM2-12 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 edema

Malawi Developmental Assessment Tool global z-scoreWithin 4 weeks of MAM outcome

Age-standardized score, -6 to +6, higher scores are better

Rate of length change2-12 weeks of supplementary feeding (until MAM outcome)

mm/week

Malawi Developmental Assessment Tool fine motor sub-domain z-scoreWithin 4 weeks of MAM outcome

Age-standardized score, -6 to +6, higher scores are better

Malawi Developmental Assessment Tool social sub-domain z-scoreWithin 4 weeks of MAM outcome

Age-standardized score, -6 to +6, higher scores are better

Diarrhea2-12 weeks of supplementary feeding (until MAM outcome)

Days, reported by caregiver, safety outcome

Graduation2-12 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.
...

DeathFrom 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) changeAcross first 4 weeks of supplementary feeding

mm/week

Change in MDAT global z-scoreFrom 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 marasmus2-12 weeks of supplementary feeding

Development of MUAC \< 11.5 cm and/or WLZ \< -3

Malawi Developmental Assessment Tool gross motor sub-domain z-scoreWithin 4 weeks of MAM outcome

Age-standardized score, -6 to +6, higher scores are better

Rate of weight changeAcross 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 kwashiorkor2-12 weeks of supplementary feeding

Development of nutritional edema (bilateral pedal pitting edema)

Docosahexaenoic acid (DHA) status2-12 weeks of supplementary feeding (at time of MAM outcome)

DHA as % of serum fatty acids

Malawi Developmental Assessment Tool language sub-domain z-scoreWithin 4 weeks of MAM outcome

Age-standardized score, -6 to +6, higher scores are better

Proportion of participations requiring hospitalization2-12 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

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