Randomized Study of Succimer (Dimercaptosuccinic Acid) on Growth of Lead-Poisoned Children
succimer
Empoisonnement par métaux lourds+5
+ Processus pathologiques
+ Empoisonnement
Étude thérapeutique
Résumé
Date de début de l'étude : 1 septembre 1997
Date à laquelle le premier participant a commencé l'étude.PROTOCOL OUTLINE: This is randomized study. Patients are randomized to receive succimer in addition to standard treatment (arm I) or standard treatment only (arm II). Succimer is administered orally 3 times a day for 7 days, then twice daily for 19 days. Patients may receive up to 3 courses. Standard treatment consists of a medical history and physical examination, environmental assessment with modification to reduce lead exposure, dietary modifications to decrease lead absorption, the use of a daily multivitamin and mineral supplement with iron, developmental screening and intervention, and frequent follow up of lead levels. If blood lead level rises above 45 mcg/dL, patient receives succimer regardless of treatment arm originally assigned. Patients are followed every 3-4 weeks for 2 months, then every 3 months for 6 months, and then every 6 months thereafter.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.175 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.Jusqu'à 6 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Asymptomatic children with confirmed venous blood lead of at least 20 mcg/dL and less than 45 mcg/dL Children with blood lead of 45 mcg/dL or greater are not randomized in this study since they probably will receive succimer regardless of being enrolled in this study --Patient Characteristics-- Other: No contraindications to the use of succimer (i.e., allergy or a lack of lead safe environment in which to live during chelation)