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New treatment option for Severe Acute Malnutrition
Official title Choline to Improve Malnutrition and Enhance Cognition
ClinicalTrials.gov ID: NCT06154174
What this study is testing
What is Amoxicillin?
Amoxicillin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for severe acute malnutrition.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 59
You may be able to join if
- 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...
You likely can't join if
- features of complicated SAM: inability to tolerate a 30g test dose of RUTF, breathing difficulties, mental status changes, sepsis, or...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Makhwira, Chikwawa, Malawi
- Mitondo, Chikwawa, Malawi
- Nkhate, Chikwawa, Malawi
- Chipolonga, Machinga, Malawi
- Chikonde, Mulanje, Malawi
- Mbiza, Mulanje, Malawi
- Milonde, Mulanje, Malawi
- Muloza, Mulanje, Malawi
- Namasalima, Mulanje, Malawi
- Naphimba, Mulanje, Malawi
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months to 59 months. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Makhwira, Chikwawa, Malawi; Mitondo, Chikwawa, Malawi; Nkhate, Chikwawa, Malawi; Chipolonga, Machinga, Malawi; Chikonde, Mulanje, Malawi; Mbiza, Mulanje, Malawi and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.