25-Hydroxyvitamin D Pharmacokinetic Study

• Status: Completed
• Trial end date: 2019-11-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the pharmacokinetic parameters of orally administered 25-hydroxyvitamin D3 [25(OH)D3] and vitamin D3 from the corresponding serum concentration-time curves in healthy adults and adults with a history of intestinal malabsorption.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boston University
• Treatments: Calcifediol; Cholecalciferol; Ergocalciferols; Hydroxycholecalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• Adult male or female with history of intestinal fat-malabsorption with confirmed diagnosis

• Taking vitamin D (ergocalciferol or cholecalciferol). Subjects taking vitamin D supplement of more than 2000 IUs (50 micrograms)/day) that may interfere with study endpoints must be willing and able to discontinue use of these supplements for the duration of the study and allow for at least a 14-day washout prior to prescreening and enrollment.

• Women of child bearing potential must be on birth control and not pregnant based on a negative pregnancy test at baseline for each of the 2 pharmacokinetic studies.

• Serum total 25(OH)D < 30 ng/mL

Exclusion Criteria:

• Unwilling to discontinue use of supplemental dose of vitamin D2 (ergocalciferol) or vitamin D3 (cholecalciferol) daily equivalent (2,000 IU/50 μg) 1 week or less prior to randomization and during the study

• On medications that can affect vitamin D metabolism including steroids such as prednisone, anti-seizure medications and medications to treat HIV.

• Tanning in a tanning bed at least one week before the study and throughout the duration of this study.

• Anyone anticipating going on holiday (where exposure to sun is imminent) 1 week before or during the entire study.

• Participation in the study or any reason which, in the opinion of the investigator makes adherence to a treatment or follow-up schedule unlikely

• History of elevated serum calcium

• Chronic hepatic or renal failure

• Subjects with a history of an adverse reaction to orally administered vitamin D.

• Inability to give informed consent