Genetic Diseases Paediatrics
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Must not have sickle cell disease or sickle cell trait (hemoglobin AA on electrophoresis); No renal or hepatic impairment; Must be at least 06 months and no more than 57 months old; Parents or guardians in charge of the child who have signed the informed consent form; Be able to take FACA® Pediatric Syrup orally; Reside in the study area (Ouagadougou)
Exclusion criteria
Exclusion criteria: Known allergies to study drugs or any of their components; Participation in any other ongoing clinical study Participant undergoing another treatment for sickle cell disease at the time of the trial; Refusal to sign informed consent by parents or guardians; Participant presenting signs of severity (chronic complications, stroke, acute chest syndrome, etc.). Participant with severe neurological and/or mental disorders; Patient suffering from any other serious pathologies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency, time of occurrence and types of adverse effects/events Significant disturbances in biological parameters [Urea, Blood Count (CBC), Transaminases (TRANSA), Creatinine (CREAT), ...] | — |
Secondary
| Measure | Time frame |
|---|---|
| Tolerable dose of FACA Pediatric Syrup | — |
Countries
Burkina Faso
Contacts
Researcher at Institut de Recherche en Sciences de la Sante