An Early Phase 1 interventional study of Calcifediol and Calciferol in Vitamin D Deficiency and Fat Malabsorption, sponsored by Boston University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-04.
Sponsored by Boston University · Early Phase 1, Interventional, and Treatment
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.
Exclusion Criteria:
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.
Drug: Calcifediol · Drug: Calciferol
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.
Drug: Calcifediol · Drug: Calciferol
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.
Drug: Calcifediol · Drug: Calciferol
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.
Drug: Calcifediol · Drug: Calciferol
One capsule of 900 micrograms of 25(OH)D
Also known as: 25(OH)D
One capsule of 900 micrograms of Vitamin D
Also known as: Vitamin D
Change in Serum vitamin D status
The serum vitamin D status (pg/mL) will be determined at multiple time points secondary to receiving a single dose of either calciferol or calcifediol. We will obtain 11 time points after each drug administration which will allow us to observe the fluctuation in vitamin D status after receiving the study drug.
Time frame: 2 weeks after administration
Change in 25-Hydroxyvitamin D Status
The serum 25(OH)D status (ng/mL) will be determined at multiple time points secondary to receiving a single dose of either calciferol or calcifediol. We will obtain 11 time points after each drug administration which will allow us to observe the fluctuation in 25(OH)D status after receiving the study drug.
Time frame: 2 weeks after administration
Serum Calcium Levels
Calcium levels will be drawn at baseline and at the end of each intervention period. This measure will allow us to ensure no change to baseline levels after receiving the study drug.
Time frame: Baseline and completion of each intervention period (2 weeks)
Serum Phosphorus Levels
Phosphorus levels will be drawn at baseline and at the end of each intervention period. This measure will allow us to ensure no change to baseline levels after receiving the study drug.
Time frame: Baseline and completion of each intervention period (2 weeks)
Serum Albumin Levels
Albumin levels will be drawn at baseline and at the end of each intervention period. This measure will allow us to ensure no change to baseline levels after receiving the study drug.
Time frame: Baseline and completion of each intervention period (2 weeks)
Serum Creatinine levels
Creatinine levels will be drawn at baseline and at the end of each intervention period. This measure will allow us to ensure no change to baseline levels after receiving the study drug.
Time frame: Baseline and completion of each intervention period (2 weeks)
Serum intact parathyroid hormone levels
iPTH levels will be drawn at baseline and at the end of each intervention period. This measure will allow us to ensure no change to baseline levels after receiving the study drug.
Time frame: Baseline and completion of each intervention period (2 weeks)
Plan to share: Yes — Data will be available upon reasonable request to mfholick@bu.edu.
Supporting information: Study protocol, Sap, Csr
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Boston University