Overview

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