NCT03035305

Seasonal Malaria Chemoprevention With or Without Lipid-based Nutrient Supplement in Children Aged 6-59 Months in Mali

Seasonal Malaria Chemoprevention With or Without Lipid-based Nutrient Supplement in Children Aged 6-59 Months in Kolokani Circle, Koulikoro Region, Mali, August-November 2016: Interventional Matched-pair Clustered Cohort

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36,717 (actual)
• Sponsor: Alliance for International Medical Action · Academic / Other
• Sex: All
• Age: 6 Months – 59 Months
• Healthy volunteers: Not accepted

Summary

SMC LNS Mali is a interventional matched-pair clustered cohort carried out between August and November 2017 in 18 health areas in Kolokani Circle, Koulikoro region, Mali. The objective of this study is to determine whether the association SMC and LNS reduces the number of confirmed malaria cases among children 6-59 months during the monthly SMC distribution sessions.

Detailed description

Main objective: To compare confirmed cases of malaria among children aged 6-59 months between the group receiving SMC combined with LNS (intervention group) and the group receiving only SMC (control group) during the monthly SMC distribution sessions (4 rounds) Secondary objectives: To compare among children aged 6-59 months between two groups * Fever cases * Acute malnutrition cases (global, moderate and severe) * Medical referral cases and their reasons Study site: The study is conducted in 18 health areas in Kolokani Circle, Koulikoro region, Mali. Each group (intervention and control groups) is composed of 9 health areas. Number of participants: Between 17500 and 22000 in each group (estimation)

Conditions

• Malaria

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lipid-based Nutrient Supplement (LNS)	For each round of SMC distribution (total of 4 rounds): * For children aged 6-11 months: 15 sachets/month or 50g every two days for 4 weeks * For children aged 12-59 months: 21 sachets/month or 50g per day for 3 weeks
DRUG	Seasonal malaria chemoprevention	For each round of SMC distribution (total of 4 rounds): * For children aged 6-11 months: sulfadoxine 250mg/pyrimethamine 12.5mg and amodiaquine 75mg * For children aged 12-59 months: sulfadoxine 500mg/pyrimethamine 25mg and amodiaquine 150mg D1 : 1 tablet sulfadoxine-pyrimethamine + 1 tablet amodiaquine D2 : 1 tablet amodiaquine D3 : 1 tablet amodiaquine

Timeline

• Start date: 2016-08-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2017-01-30
• Last updated: 2017-01-30

Locations

1 site across 1 country: Mali