Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
1500 participants
INTERVENTIONAL
2024-03-18
2026-06-30
Brief Summary
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Will provision of RUSF with added choline (500mg/day) throughout treatment of moderate acute malnutrition (up to 12 weeks) reduce deterioration to severe acute malnutrition among 6-59 month old Malawian children compared with standard RUSF?
Detailed Description
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One potential avenue for improving outcomes in MAM is modification of supplementary foods used for its treatment. Choline is an essential nutrient for human health and development, evidence for which is largely drawn from animal models of choline deficiency in which various somatic and cognitive developmental abnormalities are found. Of the trials that have evaluated choline supplementation in humans, many have focused on the role of choline in brain development and, specifically, how it may help foster improved cognitive development in the setting of various insults, such as fetal alcohol syndrome.
There is also a growing body of evidence describing the many roles choline plays outside of the brain, including in the etiology of malnutrition. Recently, choline deficiency has been implicated in the development of kwashiorkor, an enigmatic form of severe acute malnutrition characterized by pitting edema, dermatitis, hair color changes, and fatty liver disease with inflammation. Animal models of choline deficiency display a remarkably similar phenotype to kwashiorkor. When choline has been given to mice, rats, and dogs with kwashiorkor-like malnutrition, the hallmark features of the disease have resolved. This line of evidence suggests a causal role for choline deficiency in kwashiorkor, proposed mechanisms for which include choline's functions in 1-carbon metabolism, sulfur amino acid recycling, and sparing of the essential amino acid methionine. Methionine is the key deficient amino acid in maize-predominant diets, such as are consumed in Malawi. Choline is most abundant in animal-source foods, precisely those which are lacking in the diets of many rural Malawian children. Kwashiorkor accounts for more than one-third of SAM in Malawi in children under 5 years of age and 80% of MAM deterioration to SAM. If the addition of choline to supplementary foods were demonstrated to reduce deterioration to SAM among children with MAM and thereby promote recovery, this would represent an important advance in MAM treatment.
Despite the data supporting choline's essential role in human health and emerging data on its potential therapeutic role in malnutrition, there are no specifications for choline content in food aid products. Common MAM treatment options, such as corn-soy-blend plus and RUSF contain 50-70mg choline, approximately one-third of the 150-200mg recommended for well children 6mo-3y of age. This does not account for the likely increased demand for choline in the setting of malnutrition.
This will be an individually randomized, investigator-blinded, controlled clinical trial. This trial will be conducted at 10 rural sites in southern Malawi where the co-Principal Investigator, Mark Manary, has run malnutrition treatment clinics for over 15 years. The study will include 1500 children (750 per group) 6-59 months of age with uncomplicated MAM, as defined by mid-upper arm circumference (MUAC) ≥ 11.5 cm and \< 12.5 cm and/or weight-for-length z-score (WLZ) ≥ -3 and \< -2. Exclusion criteria will be presence of nutritional edema, features of complicated MAM, such as mental status changes or breathing issues, as well as participation in a separate feeding program, known allergy to study food ingredient, intention to move away from catchment area within 3 months, developmental delay, or presence of a chronic severe medical condition such as congenital heart disease. Those who wish to take part will undergo randomization, wherein they will remove a single small opaque envelope from a larger opaque envelope and open it, revealing a colored sticker that will correspond to their study group. Caregivers will receive nutrition counselling, complete questionnaires pertaining to demographic, health history/symptoms, and socioeconomic information, and be provided with a two-week supply of their allotted study food for their child. Participants will receive approximately 500 Kcal/day of either C-RUSF or RUSF until they reach a clinical outcome (i.e., graduate, deteriorate to SAM, fail/remain MAM, transfer to hospital, death, default) or for a maximum of 12 weeks. They will be asked to return to clinic fortnightly for re-assessment of anthropometry, illness symptoms, and re-provision of supplementary food until they reach a study outcome. Participants will undergo MDAT testing at time of MAM outcome as well as 5-7 months after MAM outcome to undergo repeat MDAT testing. A randomly chosen subset of participants will undergo blood spot collection at time of MAM outcome.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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C-RUSF (Ready-to-use Supplemental Food with added choline)
A daily dose of 500 Kcal of RUSF containing 500mg choline will be provided
C-RUSF (Ready-to-use Supplemental Food with added Choline)
Ready-to-use Supplemental Food with added Choline
S-RUSF (Standard Ready-to-use Supplemental Food without added choline)
A daily dose of 500 Kcal of RUSF without choline
S-RUSF (Ready-to-use Supplemental Food without added Choline)
Standard Ready-to-use Supplemental Food
Interventions
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C-RUSF (Ready-to-use Supplemental Food with added Choline)
Ready-to-use Supplemental Food with added Choline
S-RUSF (Ready-to-use Supplemental Food without added Choline)
Standard Ready-to-use Supplemental Food
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
6 Months
59 Months
ALL
No
Sponsors
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Project Peanut Butter
OTHER
Kamuzu University of Health Sciences
OTHER
Balchem Corp
INDUSTRY
Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Mark J Manary, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Chikonde Health Center
Chikonde, , Malawi
Chipolonga Health Center
Chipolonga, , Malawi
Makhwira Health Center
Makhwira, , Malawi
Mbiza Health Clinic
Mbiza, , Malawi
Milonde Health Center
Milonde, , Malawi
Mitondo Health Center
Mitondo, , Malawi
Muloza Health Clinic
Muloza, , Malawi
Namasalima Health Center
Namasalima, , Malawi
Naphimba Health Center
Naphimba, , Malawi
Nkhate Health Clinic
Nkhate, , Malawi
Countries
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Other Identifiers
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202308159
Identifier Type: -
Identifier Source: org_study_id