Leveraging the Seasonal Malaria Chemoprevention Platform to Address Malaria and Malnutrition

NCT06599593 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 438

Last updated 2026-03-06

No results posted yet for this study

Summary

In the Sahel, the malaria and malnutrition seasons overlap during the rainy season, from approximately July through October. Malaria transmission increases due to the rain and collection of standing water and malnutrition risk increases because this period is the growing season, leading up to the annual harvest in November. Seasonal malaria chemoprevention (SMC) is an antimalarial intervention that involves monthly distribution of sulfadoxine-pyrimethamine (SP) and amodiaquine (AQ) to children aged 3-59 months during the high malaria transmission season. SMC is distributed to millions of children annually in 13 countries in the Sahel, including Burkina Faso. Although SMC distribution is highly effective against clinical malaria in children, malaria remains a major cause of childhood mortality and morbidity in Burkina Faso. The SMC platform, which involves monthly door-to-door delivery of SP-AQ, is an attractive platform for delivery of additional interventions that may augment child health during this vulnerable season. Malaria and malnutrition co-occur in children and communities, and interventions for one may affect the other. For example, previous work by our group and others has shown that antimalarial treatments may improve weight gain in children with malnutrition. The pilot trial is designed to evaluate how the SMC platform may be leveraged to deliver co-interventions with SMC that may augment its efficacy and reduce the incidence of malaria and malnutrition. It is anticipated that the results of this study will provide formative data for the development and implementation of a full-scale study evaluating the effects of integration of nutritional interventions on the SMC platform. It is anticipated that such a strategy may provide optimal protection for children during the most vulnerable period of the year by delivering interventions monthly on an existing platform that directly reaches millions of children each month.

Conditions

  • Malaria Incidence
  • Seasonal Malaria Chemoprevention
  • Nutrition Assessment
  • Acute Malnutrition in Childhood
  • Acute Malnutrition
  • Integrated Community-based Intervention Package

Interventions

DIETARY_SUPPLEMENT

SQ-LNS

CHW provides all children ages 6-24 months who do not have acute malnutrition with SQ-LNS (Enov'nutributter; Nutriset; 20 g/day, approximately 100-120 calories).

OTHER

Integrated Nutritional Screening

In conjunction with SMC administration, CHWs screen children for MUAC. CHW refers children with MUAC \<12.5 to the CSPS for MAM/SAM care and to receive all standard nutritional program.

Sponsors & Collaborators

  • Centre de Recherche en Sante de Nouna, Burkina Faso

    collaborator OTHER_GOV
  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH
  • University of California, San Francisco

    lead OTHER

Principal Investigators

  • Catherine Oldenburg · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-03
Primary Completion
2025-11-12
Completion
2026-10-30

Countries

  • Burkina Faso

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06599593 on ClinicalTrials.gov