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
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
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)AmoxicillinA 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)AmoxicillinA 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
NameTimeMethod
Malawi Developmental Assessment Tool global z-score6 months after SAM outcome

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

Secondary Outcome Measures
NameTimeMethod
DHA status2-12 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-scoreWithin 1 month of SAM outcome

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

Malawi Developmental Assessment Tool gross motor sub-domain z-scoreWithin 1 month of SAM outcome

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

Malawi Developmental Assessment Tool language sub-domain z-scoreWithin 1 month of SAM outcome

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

Malawi Developmental Assessment Tool social sub-domain z-scoreWithin 1 month of SAM outcome

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

Malawi Developmental Assessment Tool global z-scoreWithin 1 month of SAM outcome

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

Proportion of participants who dieFrom enrollment to study end (6-month post-SAM-outcome MDAT visit)

Defined by caregiver report

Proportion of participants remaining with SAMAfter 12 weeks of therapeutic feeding

Continue to meet SAM criteria after feeding

Proportion of participants with kwashiorkor resolution2-12 weeks of therapeutic feeding

Resolution of nutritional edema

Time-to-kwashiorkor resolution2-12 weeks of therapeutic feeding

Time to resolution of nutritional edema

Rate of weight gain2-12 weeks of therapeutic feeding (until SAM outcome)

g/kg/day

Rate of length gain2-12 weeks of therapeutic feeding (until SAM outcome)

mm/week

Proportion of participants with recurrence of SAMFrom recovery until study end (6-month post-SAM-outcome MDAT visit)

After recovery, again meeting criteria for SAM

Change in MDAT global z-scoreFrom 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 hospitalizationEnrollment to 6-month post-SAM-outcome MDAT visit)

Safety outcome

Diarrhea2-12 weeks of therapeutic feeding (until SAM outcome)

Days, reported by caregiver, safety outcome

Recovery2-12 weeks of therapeutic feeding

Defined based on enrollment (anthropometric +/- edema) criteria

Time-to-recovery2-12 weeks of therapeutic feeding

Weeks until recovery criteria met, with recovery defined based on enrollment criteria

Trial Locations

Locations (10)

Makhwira

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Makhwira, Chikwawa, Malawi

Chikonde

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Chikonde, Mulanje, Malawi

Chipolonga

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Chipolonga, Machinga, Malawi

Milonde

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Milonde, Mulanje, Malawi

Muloza

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Muloza, Mulanje, Malawi

Nkhate

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Nkhate, Chikwawa, Malawi

Mbiza

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Mbiza, Mulanje, Malawi

Mitondo

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Mitondo, Chikwawa, Malawi

Naphimba

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Naphimba, Mulanje, Malawi

Namasalima

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Namasalima, Mulanje, Malawi

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