Assessment of a Combined Strategy of SMC + Nutrients Supplementation to Tackle Malaria and Malnutrition

• Status: Active, not recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Institut de Recherche en Sciences de la Sante, Burkina Faso
• Treatments: Nutrients; Retinol palmitate; Vitamin A; Vitamins; Zinc

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.