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

NCT ID: NCT03035305

Last Updated: 2017-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36717 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2016-11-30

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)

Conditions

Malaria

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

SMC and LNS (intervention group)

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

Group Type: EXPERIMENTAL

Lipid-based Nutrient Supplement (LNS)

Intervention Type: DIETARY_SUPPLEMENT

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

Seasonal malaria chemoprevention

Intervention Type: DRUG

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

SMC only (control group)

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

Group Type: OTHER

Seasonal malaria chemoprevention

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

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

Intervention Type: DRUG

Other Intervention Names

Sulfadoxine-pyrimethamine plus amodiaquine

Eligibility Criteria

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 59 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

Alliance médicale contre le paludisme, Mali

UNKNOWN

Sponsor Role: collaborator

Programme national de lutte contre le paludisme, Mali

UNKNOWN

Sponsor Role: collaborator

United States Agency for International Development (USAID)

FED

Sponsor Role: collaborator

European Commission

OTHER

Sponsor Role: collaborator

Ministry of health, Mali

UNKNOWN

Sponsor Role: collaborator

Alliance for International Medical Action

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Shepherd, MD

Role: PRINCIPAL_INVESTIGATOR

The Alliance for International Medical Action (ALIMA)

Renaud Becquet, PhD

Role: PRINCIPAL_INVESTIGATOR

Inserm U1219 Bordeaux Population Health Center, University of Bordeaux

Locations

Amcp/Alima

Kolokani Circle, Koulikoro, Mali

Countries

Mali

Other Identifiers

SMC LNS Mali

Identifier Type: -

Identifier Source: org_study_id