Choline to Improve Malnutrition and Enhance Cognition
- Registration Number
- NCT06154174
- Lead Sponsor
- Washington University School of Medicine
- Brief Summary
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:
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- Detailed Description
Severe acute malnutrition (SAM) affects approximately 14 million children worldwide at any one time and has an annual incidence of 3-5x this number. SAM is defined by wasting (mid-upper arm circumference \< 11.5 cm or weight-for-length z-score \< -3) or presence of bilateral pedal pitting edema. SAM increases short-term risks for infection, hospitalization, ...
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1500
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description C-RUTF (Ready-to-Use Therapeutic Food with added choline) C-RUTF (Ready-to-Use Therapeutic Food with added choline) A daily dose of 500mg choline will be added to RUTF. 2 sachets (daily dose) of RUTF will provide approximately 1000 Kcal, 14g of protein, 28g of fat, and 1 RDA of 14 micronutrients. C-RUTF (Ready-to-Use Therapeutic Food with added choline) Amoxicillin A daily dose of 500mg choline will be added to RUTF. 2 sachets (daily dose) of RUTF will provide approximately 1000 Kcal, 14g of protein, 28g of fat, and 1 RDA of 14 micronutrients. S-RUTF (Ready-to-Use Therapeutic Food without added choline) S-RUTF (Ready-to-Use Therapeutic Food without added choline) A daily dose of 5mg choline will be added to RUTF for masking. 2 sachets (daily dose) of RUTF will provide approximately 1000 Kcal, 14g of protein, 28g of fat, and 1 RDA or 14 micronutrients. S-RUTF (Ready-to-Use Therapeutic Food without added choline) Amoxicillin A daily dose of 5mg choline will be added to RUTF for masking. 2 sachets (daily dose) of RUTF will provide approximately 1000 Kcal, 14g of protein, 28g of fat, and 1 RDA or 14 micronutrients.
- Primary Outcome Measures
Name Time Method Malawi Developmental Assessment Tool global z-score 6 months after SAM outcome Age-standardized score, -6 to +6, higher scores are better
- Secondary Outcome Measures
Name Time Method DHA status 2-12 weeks of therapeutic feeding (until SAM outcome) Blood spot DHA % of total fatty acids in subset of participants
Malawi Developmental Assessment Tool fine motor sub-domain z-score Within 1 month of SAM outcome Age-standardized score, -6 to +6, higher scores are better
Malawi Developmental Assessment Tool gross motor sub-domain z-score Within 1 month of SAM outcome Age-standardized score, -6 to +6, higher scores are better
Malawi Developmental Assessment Tool language sub-domain z-score Within 1 month of SAM outcome Age-standardized score, -6 to +6, higher scores are better
Malawi Developmental Assessment Tool social sub-domain z-score Within 1 month of SAM outcome Age-standardized score, -6 to +6, higher scores are better
Malawi Developmental Assessment Tool global z-score Within 1 month of SAM outcome Age-standardized score, -6 to +6, higher scores are better
Proportion of participants who die From enrollment to study end (6-month post-SAM-outcome MDAT visit) Defined by caregiver report
Proportion of participants remaining with SAM After 12 weeks of therapeutic feeding Continue to meet SAM criteria after feeding
Proportion of participants with kwashiorkor resolution 2-12 weeks of therapeutic feeding Resolution of nutritional edema
Time-to-kwashiorkor resolution 2-12 weeks of therapeutic feeding Time to resolution of nutritional edema
Rate of weight gain 2-12 weeks of therapeutic feeding (until SAM outcome) g/kg/day
Rate of length gain 2-12 weeks of therapeutic feeding (until SAM outcome) mm/week
Proportion of participants with recurrence of SAM From recovery until study end (6-month post-SAM-outcome MDAT visit) After recovery, again meeting criteria for SAM
Change in MDAT global z-score From MDAT near time of SAM outcome to 6-month post-SAM-outcome MDAT visit 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
Proportion of participations requiring hospitalization Enrollment to 6-month post-SAM-outcome MDAT visit) Safety outcome
Diarrhea 2-12 weeks of therapeutic feeding (until SAM outcome) Days, reported by caregiver, safety outcome
Recovery 2-12 weeks of therapeutic feeding Defined based on enrollment (anthropometric +/- edema) criteria
Time-to-recovery 2-12 weeks of therapeutic feeding Weeks until recovery criteria met, with recovery defined based on enrollment criteria
Trial Locations
- Locations (10)
Makhwira
🇲🇼Makhwira, Chikwawa, Malawi
Chikonde
🇲🇼Chikonde, Mulanje, Malawi
Chipolonga
🇲🇼Chipolonga, Machinga, Malawi
Milonde
🇲🇼Milonde, Mulanje, Malawi
Muloza
🇲🇼Muloza, Mulanje, Malawi
Nkhate
🇲🇼Nkhate, Chikwawa, Malawi
Mbiza
🇲🇼Mbiza, Mulanje, Malawi
Mitondo
🇲🇼Mitondo, Chikwawa, Malawi
Naphimba
🇲🇼Naphimba, Mulanje, Malawi
Namasalima
🇲🇼Namasalima, Mulanje, Malawi