Optimized vitamin D repletion with oral thin film cholecalciferol in patients undergoing stem cell transplant

Author:

Bartlett Allison L.12ORCID,Zhang Grace2ORCID,Wallace Gregory1,McLean Stacie1,Myers Kasiani C.12ORCID,Teusink-Cross Ashley3,Taggart Cynthia4,Patel Bhaumik5,Davidson Robert5ORCID,Davies Stella M.12,Jodele Sonata12

Affiliation:

1. 1Division of Bone Marrow Transplantation and Immune Deficiency, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH

2. 2University of Cincinnati College of Medicine, Cincinnati, OH

3. 3Department of Pharmacy, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH

4. 4Department of Nutrition Therapy, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH

5. 5CURE Pharmaceutical, Oxnard, CA

Abstract

Abstract Vitamin D deficiency is common in childhood, pervasive before and after bone marrow transplant, and is associated with increased incidence of graft-versus-host disease (GVHD) and decreased survival in patients undergoing hematopoietic stem cell transplant (HSCT). Numerous barriers impede replacement, including malabsorption secondary to gut GVHD, mucositis, inability to take capsules, kidney disease, liver disease, and infection; many patients remain refractory despite vitamin D therapy. We hypothesized that a different formulation of cholecalciferol, administered on the tongue as a readily dissolving oral thin film (OTF), would ease administration and facilitate therapeutic vitamin D levels (>35 ng/mL) in patients who are refractory. In this prospective pilot study, we evaluated 20 patients after HSCT (range, day +21 - day +428 at enrollment) with serum vitamin D levels ≤35 ng/mL. Cholecalciferol OTF strips were administered for 12 weeks. Dosing was based on patient body weight and titrated per individual pharmacokinetics. Wilcoxon matched-pairs signed-rank test demonstrated marked improvement in all 20 patients who were formerly refractory, increasing from a median baseline vitamin D level of 29.2 ng/mL to 58 ng/mL at end of study (P < .0001). All patients demonstrated improvement in serum vitamin D level by week 4 on study, some of whom had been refractory for years prior. Median dose was 1 OTF strip (40 000 IU) per week. No toxicity was observed. This formulation proved to be safe, effective, efficient, and well received. We are eager to explore other patient populations, which might benefit from this promising development, and other therapeutics that might be optimized using this mode of delivery. This trial was registered at www.clinicaltrials.gov as #NCT04818957.

Publisher

American Society of Hematology

Subject

Hematology

Reference21 articles.

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3. Vitamin D and diabetes mellitus;Maddaloni;Front Horm Res,2018

4. Exploring vitamin D metabolism and function in cancer;Jeon;Exp Mol Med,2018

5. The vitamin D deficiency pandemic: approaches for diagnosis, treatment and prevention;Holick;Rev Endocr Metab Disord,2017

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