MalariaNCT03035305
Seasonal Malaria Chemoprevention With or Without Lipid-based Nutrient Supplement in Children Aged 6-59 Months in Mali
A study testing Lipid-based Nutrient Supplement (LNS) and Seasonal malaria chemoprevention in people with Malaria, run by Alliance for International Medical Action at 1 site in Mali.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Malaria
- What is being tested?
- Lipid-based Nutrient Supplement (LNS) and Seasonal malaria chemoprevention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36,717 participants
- Where
- 1 siteMali
- Study dates
- Aug 2016to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Being between 6 and 59 months old
- Resident in the study area
- Signed informed consent of the mother or the child's guardian
Who cannot join
- Children allergic to milk, peanuts, sulfadoxine-pyrimethamine or amodiaquine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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
- Being tested
- Lipid-based Nutrient Supplement (LNS), Seasonal malaria chemoprevention
- Keywords
- Seasonal malaria chemoprevention, Lipid-based nutrient supplement, Children, Mali
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipid-based Nutrient Supplement (LNS)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 chemopreventionDrug
Also called Sulfadoxine-pyrimethamine plus amodiaquine
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Lipid-based Nutrient Supplement (LNS); Drug: Seasonal malaria chemoprevention |
| 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 Receives: Drug: Seasonal malaria chemoprevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed malaria case
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.
Measured: 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
Secondary outcomes (5)
Fever case
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.
Measured: 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 case
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.
Measured: 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 case
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.
Measured: 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 case
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.
Measured: 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
Medical referral case
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study startAug 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36,717 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for International Medical Action
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Alliance médicale contre le paludisme, Mali, Programme National de Lutte contre le Paludisme, Niger, United States Agency for International Development (USAID), European Commission, Ministry of health, Mali
- Responsible party
- Sponsor
- Investigators
- Susan Shepherd, MD, Principal investigator, The Alliance for International Medical Action (ALIMA)Renaud Becquet, PhD, Principal investigator, Inserm U1219 Bordeaux Population Health Center, University of Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035305
- Sponsor's protocol ID
- SMC LNS Mali
- Status last verified
- Jan 2017
- First submitted
- 17 Jan 2017
- Last updated
- 30 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03035305
- Acronym / sponsor ID
- SMC LNS Mali
- Conditions
- Malaria
- Keywords
- Seasonal malaria chemoprevention, Lipid-based nutrient supplement, Children, Mali
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36,717 participants (actual)
- Lead sponsor
- Alliance for International Medical ActionUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Alliance médicale contre le paludisme, Mali, Programme National de Lutte contre le Paludisme, Niger, United States Agency for International Development (USAID), European Commission, Ministry of health, Mali
- Study start
- Aug 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 30 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMC and LNS (intervention group) | Experimental | Dietary Supplement: Lipid-based Nutrient Supplement (LNS), Drug: Seasonal malaria chemopreventionChildren 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 | Drug: Seasonal malaria chemopreventionChildren included in the 9 health areas of the control group receiving seasonal malaria chemoprevention with sulfadoxine-pyrimethamine plus amodiaquine |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Being between 6 and 59 months old
- Resident in the study area
- Signed informed consent of the mother or the child's guardian
Key exclusion criteria (1 listed)
- Children allergic to milk, peanuts, sulfadoxine-pyrimethamine or amodiaquine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Dietary supplement | SMC and LNS (intervention group) |
| Seasonal malaria chemopreventionAlso: Sulfadoxine-pyrimethamine plus amodiaquineFor 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 | Drug | SMC and LNS (intervention group), SMC only (control group) |
Primary outcome
Confirmed malaria case
Time frame: 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.
5 secondary outcomes
Fever case
Time frame: 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 case
Time frame: 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 case
Time frame: 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 case
Time frame: 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
Medical referral case
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
- Individual participant dataSharing planned: No
Related trials for Malaria
Active, not recruitingObservational study
Trajectories and Mechanisms of Recovery From Malaria: An Observational Study
Malaria
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Shepherd, MD principal investigator
The Alliance for International Medical Action (ALIMA)
Renaud Becquet, PhD principal investigator
Inserm U1219 Bordeaux Population Health Center, University of Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lipid-based Nutrient Supplement (LNS) and Seasonal malaria chemoprevention in people with Malaria, run by Alliance for International Medical Action at 1 site in Mali.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mali. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirmed malaria case (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2017.