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

Not Applicable

Completed

• Conditions: Malaria
• Interventions: Drug: Seasonal malaria chemoprevention; Dietary Supplement: Lipid-based Nutrient Supplement (LNS)

• Registration Number: NCT03035305
• Lead Sponsor: Alliance for International Medical Action

Brief 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)

Study Timeline

• Study Start: 2016-08
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2017-01
• Study First Submitted: 2017-01-17
• Study First Submitted QC: 2017-01-25
• Last Update Submitted: 2017-01-25
• Study First Posted: 2017-01-30
• Last Update Posted: 2017-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36717

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SMC only (control group)	Seasonal malaria chemoprevention	Children included in the 9 health areas of the control group receiving seasonal malaria chemoprevention with sulfadoxine-pyrimethamine plus amodiaquine
SMC and LNS (intervention group)	Lipid-based Nutrient Supplement (LNS)	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
SMC and LNS (intervention group)	Seasonal malaria chemoprevention	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

Primary Outcome Measures

Name	Time	Method
Confirmed malaria case	From the 2nd round of SMC distribution (4 weeks after the date of inclusion) to the 4th round of SMC distribution (12 weeks after the date of inclusion), assessed up to 8 weeks	Malaria case is confirmed by a positive malaria rapid diagnostic test. This outcome will be defined as the occurrence of at least one confirmed malaria case from the 2nd through the 4th round of SMC distribution.

Secondary Outcome Measures

Name	Time	Method
Fever case	From the 2nd round of SMC distribution (4 weeks after the date of inclusion) to the 4th round of SMC distribution (12 weeks after the date of inclusion), assessed up to 8 weeks	Fever case is defined by an axillary temperature greater than 37.5⁰C measured by electronic thermometer or notion fever within 48 hours. This outcome will be defined as the occurrence of at least one fever case from the 2nd through the 4th round of SMC distribution.
Global acute malnutrition case	From the 2nd round of SMC distribution (4 weeks after the date of inclusion) to the 4th round of SMC distribution (12 weeks after the date of inclusion), assessed up to 8 weeks	Global acute malnutrition is defined by MUAC \<125mm (orange or red color MUAC) and/or bilateral edema. This outcome will be defined as the occurrence of at least one global acute malnutrition case from the 2nd through the 4th round of SMC distribution.
Moderate acute malnutrition case	From the 2nd round of SMC distribution (4 weeks after the date of inclusion) to the 4th round of SMC distribution (12 weeks after the date of inclusion), assessed up to 8 weeks	Moderate acute malnutrition is defined by MUAC between 115-124mm (orange color MUAC). This outcome will be defined as the occurrence of at least one moderate acute malnutrition case from the 2nd through the 4th round of SMC distribution.
Severe acute malnutrition case	From the 2nd round of SMC distribution (4 weeks after the date of inclusion) to the 4th round of SMC distribution (12 weeks after the date of inclusion), assessed up to 8 weeks	Severe acute malnutrition is defined by MUAC \<115mm (red color MUAC) and/or bilateral edema. This outcome will be defined as the occurrence of at least one severe acute malnutrition case from the 2nd through the 4th round of SMC distribution.
Medical referral case	From the 2nd round of SMC distribution (4 weeks after the date of inclusion) to the 4th round of SMC distribution (12 weeks after the date of inclusion), assessed up to 8 weeks	This outcome will be defined as the occurrence of at least one illness of sufficient severity to warrant referral to the nearest medical structure for evaluation from the 2nd through the 4th round of SMC distribution.

Trial Locations

Locations (1)

Amcp/Alima; 🇲🇱 Kolokani Circle, Koulikoro region, Mali