Trial | NCT03035305  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    36717
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.
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 Started
Aug 31
2016
Primary Completion
Nov 30
2016
Study Completion
Nov 30
2016
Last Update
Jan 30
2017
Estimate

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

  • Other names: Sulfadoxine-pyrimethamine plus amodiaquine

SMC and LNS (intervention group) Experimental

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 only (control group) Other

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

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
No Results Posted