title: Calcitriol for Oral Mucositis Prevention in Patients With Fanconi Anemia Undergoing Hematopoietic SCT: A Double-Blind, Randomized, Placebo-Controlled Trial.
abstract: Fanconi anemia is a rare inherited aplastic anemia, which is cured only by hematopoietic stem-cell transplantation (HSCT). One of the most debilitating complications of high-dose chemotherapy regimen before HSCT is oral mucositis (OM), which occurs frequently in this population. Vitamin D has identified immunoregulatory, anti-inflammatory, and antioxidant role. This study was designed to examine the efficacy of vitamin D in the prevention of OM in patients with Fanconi anemia undergoing allogenic HSCT. Twenty-eight patients were enrolled in the study. They received either calcitriol (0.025 μg) or placebo capsule once daily, from the first day of chemotherapy schedule for 14 consecutive days. Incidence of OM was assessed as the primary outcome. Moreover, the association of baseline vitamin D level with OM was evaluated. In this study, calcitriol did not change OM incidence (P = 1) and severity (P = 0.54) significantly; however, a significant association of baseline vitamin D level with OM complete resolution was found (P = 0.03; hazard ratio, 1.01; 95% confidence interval, 1.00-1.01). In conclusion, we did not find considerable benefits of calcitriol in the prevention of OM. However, further studies with bigger sample size and different calcitriol supplementation schedules are needed to confirm these findings.
authors.affiliation: 1Hematology-Oncology and Stem Cell Transplantation Research Center, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran; 2Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran; 3Research Center for Rational Use of Drugs, Tehran University of Medical Sciences, Tehran, Iran; and 4Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Amir Ali
authors.initials: AA
authors.lastname: Hamidieh
authors.forename: Mona
authors.initials: M
authors.lastname: Sherafatmand
authors.forename: Ava
authors.initials: A
authors.lastname: Mansouri
authors.forename: Molouk
authors.initials: M
authors.lastname: Hadjibabaie
authors.forename: Asieh
authors.initials: A
authors.lastname: Ashouri
authors.forename: Zahra
authors.initials: Z
authors.lastname: Jahangard-Rafsanjani
authors.forename: Kheirollah
authors.initials: K
authors.lastname: Gholami
authors.forename: Mohammad Reza
authors.initials: MR
authors.lastname: Javadi
authors.forename: Ardeshir
authors.initials: A
authors.lastname: Ghavamzadeh
authors.forename: Mania
authors.initials: M
authors.lastname: Radfar
mesh_terms: D000293:Adolescent; D000970:Antineoplastic Agents / Q000009:adverse effects*; D002117:Calcitriol / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005199:Fanconi Anemia / Q000628:therapy*; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation / Q000379:methods*; D006801:Humans; D007223:Infant; D008297:Male; D013280:Stomatitis / Q000209:etiology* / Q000517:prevention & control*
chemical_list: D000970:Antineoplastic Agents; D002117:Calcitriol