Stoss therapy is safe for treatment of vitamin D deficiency in pediatric patients undergoing HSCT.
Bone Marrow Transplant
; 56(9): 2137-2143, 2021 09.
Article
en En
| MEDLINE
| ID: mdl-33875811
ABSTRACT
Vitamin D deficiency remains common among pediatric patients undergoing hematopoietic stem cell transplant (HSCT) despite both aggressive and standard of care strategies. This study examined the safety and efficacy of single high-dose oral vitamin D therapy (Stoss therapy) for treatment of vitamin D deficiency in HSCT recipients. Patients ages 1-21 years presenting for HSCT were randomized to receive either Stoss regimen plus weekly/daily supplementation or standard of care, per US Endocrine Society guidelines. Among the total 48 subjects, 22 (46%) were randomized to Stoss and 26 (54%) to control arms. Baseline 25-hydroxyvitamin D (25-OHD) levels were insufficient/deficient in total of 34 (71%) patients, without difference between treatment groups. The Stoss regimen was well tolerated and no toxicity was observed. At Day +30, mean 25-OHD levels were significantly higher (P = 0.04) with Stoss (42.3 ± 12 µg/l) compared to controls (35.6 ± 14.3 µg/l), and a higher proportion of Stoss patients had adequate vitamin D levels than controls (85% vs 65%). Stoss therapy is a safe and efficacious treatment option for vitamin D deficiency in children undergoing HSCT and may achieve sufficient levels more rapidly than standard of care. This trial was registered at www.clinicaltrials.gov as NCT03176849.
Texto completo:
1
Base de datos:
MEDLINE
Asunto principal:
Deficiencia de Vitamina D
/
Trasplante de Células Madre Hematopoyéticas
Tipo de estudio:
Clinical_trials
/
Guideline
Límite:
Adolescent
/
Adult
/
Child
/
Child, preschool
/
Humans
/
Infant
Idioma:
En
Revista:
Bone Marrow Transplant
Asunto de la revista:
TRANSPLANTE
Año:
2021
Tipo del documento:
Article
País de afiliación:
Estados Unidos