25-Hydroxyvitamin D Pharmacokinetic Study

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03401541
• Other study ID #: H-37167
• Status: Completed
• Phase: Early Phase 1
• Start date: October 1, 2018
• Est. completion date: November 1, 2019

Study information

• Verified date: June 2020
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 with a history of intestinal malabsorption.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fat Malabsorption
• Malabsorption Syndromes
• Vitamin D Deficiency

Intervention

Drug:
• Calcifediol
One capsule of 900 micrograms of 25(OH)D
• Calciferol
One capsule of 900 micrograms of Vitamin D

Locations

Country	Name	City	State
United States	Solomon Carter Fuller Mental Health Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 weeks after administration
Primary	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.	2 weeks after administration
Secondary	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.	Baseline and completion of each intervention period (2 weeks)
Secondary	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.	Baseline and completion of each intervention period (2 weeks)
Secondary	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.	Baseline and completion of each intervention period (2 weeks)
Secondary	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.	Baseline and completion of each intervention period (2 weeks)
Secondary	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.	Baseline and completion of each intervention period (2 weeks)