Stoss therapy is safe for treatment of vitamin D deficiency in pediatric patients undergoing HSCT
Autor: | Dana Salzberg, Sandhya Bansal, Lucia Mirea, Jessica Bodea, Holly K. Miller, Roberta H. Adams, Kristen Beebe, Biljana Horn, Alexander Ngwube, Courtney Campbell, Thalachallour Mohanakumar, Paul Castillo |
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Rok vydání: | 2021 |
Předmět: |
Transplantation
medicine.medical_specialty business.industry medicine.medical_treatment Hematology Hematopoietic stem cell transplantation medicine.disease vitamin D deficiency law.invention 03 medical and health sciences Regimen 0302 clinical medicine Randomized controlled trial law 030220 oncology & carcinogenesis Internal medicine Toxicity Vitamin D and neurology Endocrine system Medicine Young adult business 030215 immunology |
Zdroj: | Bone Marrow Transplantation. 56:2137-2143 |
ISSN: | 1476-5365 0268-3369 |
Popis: | 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. |
Databáze: | OpenAIRE |
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