Cognitive Impairment Clinical Trial
— CHIME-SAMOfficial title:
Choline to Improve Malnutrition and Enhance Cognition
NCT number | NCT06154174 |
Other study ID # | 202308160 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | December 5, 2023 |
Est. completion date | March 2026 |
The goal of this clinical trial is to test adding choline to ready-to-use therapeutic food (RUTF) in children with severe acute malnutrition (SAM) in Malawi. The main question it aims to answer is: - Will the addition of a 500mg daily dose of choline to RUTF during treatment for SAM improve cognitive development among 6-59-month-old Malawian children compared with standard RUTF without added choline?
Status | Recruiting |
Enrollment | 1500 |
Est. completion date | March 2026 |
Est. primary completion date | March 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 59 Months |
Eligibility | Inclusion Criteria: - 6-59 months of age - mid-upper arm circumference < 11.5 cm and/or weight-for-length z-score < -3 and/or presence of bilateral pedal pitting edema - willingness to comply with all study procedures and availability for the duration of the study, including no plan to move from the catchment area of a participating clinic Exclusion Criteria: - features of complicated SAM: inability to tolerate a 30g test dose of RUTF, breathing difficulties, mental status changes, sepsis, or physician/nursing clinical assessment that the child needs immediate hospitalization - participation in a separate feeding program within the past month - known allergy to study food ingredient (peanut, milk, fish) - intention to move away from catchment area within 9 months - developmental delay - presence of a chronic severe medical condition (other than TB and HIV), such as congenital heart disease |
Country | Name | City | State |
---|---|---|---|
Malawi | Chikonde | Chikonde | Mulanje |
Malawi | Chipolonga | Chipolonga | Machinga |
Malawi | Makhwira | Makhwira | Chikwawa |
Malawi | Mbiza | Mbiza | Mulanje |
Malawi | Milonde | Milonde | Mulanje |
Malawi | Mitondo | Mitondo | Chikwawa |
Malawi | Muloza | Muloza | Mulanje |
Malawi | Namasalima | Namasalima | Mulanje |
Malawi | Naphimba | Naphimba | Mulanje |
Malawi | Nkhate | Nkhate | Chikwawa |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine | Balchem Corporation, Kamuzu University of Health Sciences, Project Peanut Butter |
Malawi,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | MDAT global z-score by age | Subgroups: enrollment <12 vs. >=12 months of age, -6 to +6, higher scores are better | 6-month post-outcome MDAT visit | |
Other | MDAT global z-score by SAM outcome status | Subgroups: Recovered vs. Other, -6 to +6, higher scores are better | 6-month post-outcome MDAT visit | |
Primary | Malawi Developmental Assessment Tool global z-score | Age-standardized score, -6 to +6, higher scores are better | 6 months after SAM outcome | |
Secondary | Malawi Developmental Assessment Tool gross motor sub-domain z-score | Age-standardized score, -6 to +6, higher scores are better | 6 months after SAM outcome | |
Secondary | Malawi Developmental Assessment Tool fine motor sub-domain z-score | Age-standardized score, -6 to +6, higher scores are better | 6 months after SAM outcome | |
Secondary | Malawi Developmental Assessment Tool language sub-domain z-score | Age-standardized score, -6 to +6, higher scores are better | 6 months after SAM outcome | |
Secondary | Malawi Developmental Assessment Tool social sub-domain z-score | Age-standardized score, -6 to +6, higher scores are better | 6 months after SAM outcome | |
Secondary | Malawi Developmental Assessment Tool global z-score | Age-standardized score, -6 to +6, higher scores are better | Within 1 month of SAM outcome | |
Secondary | Malawi Developmental Assessment Tool gross motor sub-domain z-score | Age-standardized score, -6 to +6, higher scores are better | Within 1 month of SAM outcome | |
Secondary | Malawi Developmental Assessment Tool fine motor sub-domain z-score | Age-standardized score, -6 to +6, higher scores are better | Within 1 month of SAM outcome | |
Secondary | Malawi Developmental Assessment Tool language sub-domain z-score | Age-standardized score, -6 to +6, higher scores are better | Within 1 month of SAM outcome | |
Secondary | Malawi Developmental Assessment Tool social sub-domain z-score | Age-standardized score, -6 to +6, higher scores are better | Within 1 month of SAM outcome | |
Secondary | Recovery | Defined based on enrollment (anthropometric +/- edema) criteria | 2-12 weeks of therapeutic feeding | |
Secondary | DHA status | Blood spot DHA % of total fatty acids in subset of participants | 2-12 weeks of therapeutic feeding (until SAM outcome) | |
Secondary | Time-to-recovery | Weeks until recovery criteria met, with recovery defined based on enrollment criteria | 2-12 weeks of therapeutic feeding | |
Secondary | Proportion of participants who die | Defined by caregiver report | 2-12 weeks of therapeutic feeding | |
Secondary | Proportion of participants who die | Defined by caregiver report | From enrollment to study end (6-month post-SAM-outcome MDAT visit) | |
Secondary | Proportion of participants remaining with SAM | Continue to meet SAM criteria after feeding | After 12 weeks of therapeutic feeding | |
Secondary | Proportion of participants with kwashiorkor resolution | Resolution of nutritional edema | 2-12 weeks of therapeutic feeding | |
Secondary | Time-to-kwashiorkor resolution | Time to resolution of nutritional edema | 2-12 weeks of therapeutic feeding | |
Secondary | Rate of weight gain | g/kg/day | 2-12 weeks of therapeutic feeding (until SAM outcome) | |
Secondary | Rate of length gain | mm/week | 2-12 weeks of therapeutic feeding (until SAM outcome) | |
Secondary | Proportion of participants with recurrence of SAM | After recovery, again meeting criteria for SAM | From recovery until study end (6-month post-SAM-outcome MDAT visit) | |
Secondary | Change in MDAT global z-score | Difference in MDAT global z-score between 6-month post-SAM outcome visit and MDAT, global z-score measured within 1 month of SAM outcome, more positive scores are better | From MDAT near time of SAM outcome to 6-month post-SAM-outcome MDAT visit | |
Secondary | Proportion of participations requiring hospitalization | Safety outcome | Enrollment to 6-month post-SAM-outcome MDAT visit) | |
Secondary | Diarrhea | Days, reported by caregiver, safety outcome | 2-12 weeks of therapeutic feeding (until SAM outcome) |
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