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

Alliance for International Medical Action

Status: Completed

Conditions: Malaria

Treatments: Drug: Seasonal malaria chemoprevention; Dietary Supplement: Lipid-based Nutrient Supplement (LNS)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03035305

SMC LNS Mali

Details and patient eligibility

About

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.

Full 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)

Enrollment: 36,717 patients

Sex: All

Ages: 6 to 59 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Being between 6 and 59 months old
• Resident in the study area
• Signed informed consent of the mother or the child's guardian

Exclusion criteria

• Children allergic to milk, peanuts, sulfadoxine-pyrimethamine or amodiaquine

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36,717 participants in 2 patient groups

SMC and LNS (intervention group)

Experimental group

Description:

Children included in the 9 health areas of the intervention group receiving both lipid-based nutrient supplement and seasonal malaria chemoprevention with sulfadoxine-pyrimethamine plus amodiaquine

Treatment:

Drug: Seasonal malaria chemoprevention

Dietary Supplement: Lipid-based Nutrient Supplement (LNS)

SMC only (control group)

Other group

Description:

Children included in the 9 health areas of the control group receiving seasonal malaria chemoprevention with sulfadoxine-pyrimethamine plus amodiaquine

Treatment:

Drug: Seasonal malaria chemoprevention