25-Hydroxyvitamin D Pharmacokinetic Study

Completed · Early Phase 1

Conditions studied: Vitamin D Deficiency, Fat Malabsorption

In brief

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.

Key facts

Study ID

NCT03401541

Run by

Boston University

People needed

16

Starts

2018-10-01

Expected to finish

2019-11-01

Last updated by the study team

2020-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Solomon Carter Fuller Mental Health Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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