Vitamin D Deficiency Clinical Trial
Official title:
Pilot Clinical Trial to Evaluate the Pharmacokinetics of Orally Administered 25-hydroxyvitamin D3 and Vitamin D3 in Healthy Adults and Adults With a History of Intestinal Malabsorption
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.
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 subjects will be prescreened for 25(OH)D levels to include subjects with
25(OH)D<30 ng/ml. The subjects will be randomized to receive a single oral dose of 900 µg of
either vitamin D3 or 25(OH)D3. Blood samples will be taken at baseline and at 2,4,6,8,12
hours and days 1,2,3, 7 and 14. After a washout period of at least 14 days (2 weeks) the
subjects will receive in a double blinded manner a single oral dose of 900 µg of either
25(OH)D3 or vitamin D3 (depending on which one they took in the randomization) any time after
the washout. Blood samples will be taken at baseline and at 2,4,6,8,12 hours and days
1,2,3,7, 14.
Serum levels of calcium, phosphorus, albumin, creatinine, intact parathyroid hormone (iPTH)
will be obtained at baseline and at day 14 (or within a reasonable time if unable to come in
on the exact day). Vitamin D and 25(OH)D will be determined on all the blood samples
collected at the various times.
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