Status:
COMPLETED
25-Hydroxyvitamin D Pharmacokinetic Study
Lead Sponsor:
Boston University
Conditions:
Vitamin D Deficiency
Fat Malabsorption
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief 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 w...
Detailed Description
Patients with a history of intestinal malabsorption (n=10) and healthy volunteers (n=10); (of both sexes and all ethnicities) will be recruited in this randomized double-blind crossover study. All sub...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2019
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03401541
Start Date
October 1 2018
End Date
November 1 2019
Last Update
June 4 2020
Active Locations (1)
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1
Solomon Carter Fuller Mental Health Center
Boston, Massachusetts, United States, 02118