Assessment of a Combined Strategy of SMC + Nutrients Supplementation to Tackle Malaria and Malnutrition
SMC-NUT
1 other identifier
interventional
1,059
1 country
1
Brief Summary
Malaria and malnutrition represent major public health concerns worldwide especially in Sub-Sahara Africa. Despite implementation of Seasonal Malaria Chemoprophylaxis (SMC), an intervention aimed at reducing malaria prevalence among children aged 6- 59 months, the burden of malaria and associated mortality among children below age 5 years remains high in Burkina Faso. This raises the question of what hiding factors may negatively affect the responsiveness of SMC intervention. Malnutrition, in particular micronutrient deficiency, is one of these potential factors that can negatively affect the effectiveness of SMC. Treating micronutrient deficiencies is known to reduce the prevalence of malaria mortality in highly prevalent malaria zone such as rural settings. Therefore, the hypothesis that a combined strategy of SMC together with a daily oral nutrients supplement (Vitamin A-Zinc OR fortified peanut butter-like paste-Plumpy'Doz) will enhance the immune response and decrease the incidence of malaria in this population and at the same time reduce the burden of malnutrition among children under SMC coverage was postulated. Prior to the SMC implementation by the National Malaria Control Program (NMCP), children under SMC coverage will be identified through the Health and Demographic Surveillance System (HDSS). Children will be randomly assigned to one of the three groups (a) SMC + Vitamin A alone, (b) SMC + Vitamin A+ Zinc, or (c) SMC+Vitamin A + Plumpy'Doz. After each SMC monthly distribution, children will be visited at home to confirm drug administration and follow-up for one year. Anthropometric indicators will be recorded at each visit. Blood samples will be collected for thick and thin film and hemoglobin measurement and spotted onto filter paper for further PCR analyses. This project will serve as a pilot of an integrated strategy in order to mutualize resources for best impact. By relying on existing strategies, the policy implementation of this joint intervention will be scalable at country and regional levels.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2020
CompletedFirst Posted
Study publicly available on registry
January 23, 2020
CompletedStudy Start
First participant enrolled
July 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 4, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedMarch 8, 2022
March 1, 2021
12 months
January 15, 2020
March 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
The relative risk of the incidence of clinical malaria
The ration of the number of malaria cases in intervention over comparator arm hospitalisation and mortality in SMC group compared to SMC + supplement groups
One year
The mid-upper arm circumference gain
The difference between baseline MUAC and MUAC at the end of the study period in the intervention groups compared to the control group
One year
Weight gain
Difference between weight at baseline and weight at the end of the study
One year
prevalence of anemia
prevalence of anemia in each arm
one year
Secondary Outcomes (7)
The prevalence of mutant pfcrt allele
One year
The prevalence of mutant pfmdr1 allele
One year
The prevalence of mutant dhfr allele
One year
The prevalence of mutant dhps allele
One year
SMC coverage
Six months
- +2 more secondary outcomes
Study Arms (3)
SMC + Vitamin A alone
ACTIVE COMPARATORChildren under SMC Coverage, receiving AQSP and Vitamin A supplementation alone
SMC+ Vitamin A + Plumpy'Doz
EXPERIMENTALChildren under SMC Coverage, receiving AQSP + Vitamin A plus Plumpy'Doz supplementation
SMC+ Vitamin A + Zinc
EXPERIMENTALChildren under SMC Coverage, receiving AQSP + Vitamin A plus Zinc supplementation
Interventions
Three days treatment of all children with AQSP for SMC
Daily supplementation of children with Plumpy'Doz
Single dose supplementation with Vitamin A to all children
Eligibility Criteria
You may qualify if:
- Children under SMC coverage (6-59months old),
- living within the HDSS coverage area,
- ability to complete the study follow-up period,
- written consent obtained from parents
You may not qualify if:
- individual not under SMC coverage,
- Children under SMC coverage who did not receive the treatment (Amodiaquine-Sulfadoxine-Pyrimethamine) or the Vitamin Supplementation,
- ill individual at the time of the enrolment including uncomplicated/severe malaria or severe malnutrition,
- known allergy to Vitamin A or Zinc or Plumpy'Doz,
- planned travel or inability to complete the study follow-up,
- and unwillingness to participate to the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institut de Recherche en Sciences de la Santé/ Clinical Research Unit of Nanoro
Ouagadougou, Kadiogo, 218 CMS 11, Burkina Faso
Related Publications (2)
Sondo P, Kabore B, Rouamba T, Compaore E, Tibiri YNG, Kabore HALF, Derra K, Tahita MC, Ilboudo H, Tougri G, Bouda I, Dakyo T, Kafando H, Ouedraogo F, Rouamba E, Hien SF, Kazienga A, Compaore CS, Bambara E, Nana M, Dahal P, Garanet F, Kabore W, Lefevre T, Guerin P, Tinto H. Enhanced effect of seasonal malaria chemoprevention when coupled with nutrients supplementation for preventing malaria in children under 5 years old in Burkina Faso: a randomized open label trial. Malar J. 2023 Oct 18;22(1):315. doi: 10.1186/s12936-023-04745-6.
PMID: 37853408DERIVEDSondo P, Tahita MC, Rouamba T, Derra K, Kabore B, Compaore CS, Ouedraogo F, Rouamba E, Ilboudo H, Bambara EA, Nana M, Sawadogo EY, Sorgho H, Some AM, Valea I, Dahal P, Traore/Coulibaly M, Tinto H. Assessment of a combined strategy of seasonal malaria chemoprevention and supplementation with vitamin A, zinc and Plumpy'Doz to prevent malaria and malnutrition in children under 5 years old in Burkina Faso: a randomized open-label trial (SMC-NUT). Trials. 2021 May 24;22(1):360. doi: 10.1186/s13063-021-05320-7.
PMID: 34030705DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2020
First Posted
January 23, 2020
Study Start
July 13, 2020
Primary Completion
July 4, 2021
Study Completion
March 1, 2022
Last Updated
March 8, 2022
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data will be shared within a year after database lock for unlimited time
- Access Criteria
- free access
Data on Plasmodium resistance will be shared with Infectious Diseases Data Observatory (IDDO)/ WorldWide Antimalarial Resistance Network (WWARN). The WHO will have access to the data to facilitate the development of new malaria control policy. Data will be made available to partners and as well as for other interested groups through the IDDO platform.