25-Hydroxyvitamin D Pharmacokinetic Study
Vitamin D Deficiency, Fat Malabsorption
About this trial
This is an interventional treatment trial for Vitamin D Deficiency focused on measuring Calcifediol (25(OH)D), Calciferol (Vitamin D)
Eligibility 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
Sites / Locations
- Solomon Carter Fuller Mental Health Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Fat-Mal, calcifediol then calciferol
Fat-Mal, calciferol then calcifediol
Non Fat-Mal, calcifediol then calciferol
Non Fat-Mal, calciferol then calcifediol
Participants with diagnosed fat malabsorption syndrome will initially receive one capsule of calcifediol for the first round of blood draws and then receive one capsule of calciferol for the second round.
Participants with diagnosed fat malabsorption syndrome will initially receive one capsule of calciferol for the first round of blood draws and then receive one capsule of calcifediol for the second round.
Participants that do not have a diagnosed fat malabsorption syndrome will initially receive one capsule of calcifediol for the first round of blood draws and thenreceive one capsule of calciferol for the second round.
Participants that do not have a diagnosed fat malabsorption syndrome will initially receive one capsule of calciferol for the first round of blood draws and then receive one capsule of calcifediol for the second round.