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The Relapse to Acute Malnutrition Prevention (RAMP) Trial
Sponsor: Action Against Hunger USA
Summary
This individually randomized controlled trial uses a 2x2 factorial design to evaluate the effects of azithromycin and small-quantity lipid-based nutrient supplements (SQ-LNS) on sustained nutritional recovery following initial recovery from uncomplicated severe acute malnutrition (SAM) in South Sudan. The study will evaluate the effects of each intervention component alone and when given together, compared with standard care, on sustained recovery for 12 months post initial SAM recovery.
Official title: The RAMP Trial: Effectiveness of Azithromycin and Small-quantity Lipid-based Nutrient Supplements (SQ-LNS) on Sustained Nutritional Recovery Among Children Recovered From Uncomplicated Severe Acute Malnutrition in South Sudan
Key Details
Gender
All
Age Range
6 Months - 59 Months
Study Type
INTERVENTIONAL
Enrollment
3750
Start Date
2026-10
Completion Date
2028-12
Last Updated
2026-10-13
Healthy Volunteers
No
Interventions
Azithromycin
A single oral dose of 20mg/kg azithromycin will be administered under direct observation to children once every four weeks (with four weeks equaling one month of clinic services) for six monthly visits. It will be supplied as a 200 mg/5mL oral suspension reconstituted on-site and dosed using a calibrated dosing cup.
Placebo (Azithromycin)
A single oral dose of matched placebo suspension equivalent to a 20mg/kg azithromycin dose will be administered under direct observation to children once every four weeks (with four weeks equaling one month of clinic services) at six monthly visits. It will be supplied as a 200 mg/5mL matched oral suspension reconstituted on-site and dosed using a calibrated dosing cup.
Small-quantity Lipid-based Nutrient Supplements
One 20g sachet of SQ-LNS (120 kcal) will be provided daily consumption by children. It will be dispensed to caregivers as a monthly supply of 28 sachets at six monthly visits. (Four weeks equals one month of clinic services.) Open label.
Locations (1)
Action Against Hunger USA
Gogrial West, Warrap, South Sudan