25-Hydroxyvitamin D Pharmacokinetic Study

NCT ID: NCT03401541

Last Updated: 2020-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2019-11-01

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 with a history of intestinal malabsorption.

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 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.

Conditions

Vitamin D Deficiency; Fat Malabsorption

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Fat-Mal, calcifediol then calciferol

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.

Group Type: EXPERIMENTAL

Calcifediol

Intervention Type: DRUG

One capsule of 900 micrograms of 25(OH)D

Calciferol

Intervention Type: DRUG

One capsule of 900 micrograms of Vitamin D

Fat-Mal, calciferol then calcifediol

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.

Group Type: EXPERIMENTAL

Calcifediol

Intervention Type: DRUG

One capsule of 900 micrograms of 25(OH)D

Calciferol

Intervention Type: DRUG

One capsule of 900 micrograms of Vitamin D

Non Fat-Mal, calcifediol then 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.

Group Type: EXPERIMENTAL

Calcifediol

Intervention Type: DRUG

One capsule of 900 micrograms of 25(OH)D

Calciferol

Intervention Type: DRUG

One capsule of 900 micrograms of Vitamin D

Non Fat-Mal, calciferol then calcifediol

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.

Group Type: EXPERIMENTAL

Calcifediol

Intervention Type: DRUG

One capsule of 900 micrograms of 25(OH)D

Calciferol

Intervention Type: DRUG

One capsule of 900 micrograms of Vitamin D

Interventions

Calcifediol

One capsule of 900 micrograms of 25(OH)D

Intervention Type: DRUG

Calciferol

One capsule of 900 micrograms of Vitamin D

Intervention Type: DRUG

Other Intervention Names

25(OH)D; 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael F Holick, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

Solomon Carter Fuller Mental Health Center

Boston, Massachusetts, United States

Countries

United States

References

Charoenngam N, Kalajian TA, Shirvani A, Yoon GH, Desai S, McCarthy A, Apovian CM, Holick MF. A pilot-randomized, double-blind crossover trial to evaluate the pharmacokinetics of orally administered 25-hydroxyvitamin D3 and vitamin D3 in healthy adults with differing BMI and in adults with intestinal malabsorption. Am J Clin Nutr. 2021 Sep 1;114(3):1189-1199. doi: 10.1093/ajcn/nqab123.

Reference Type: DERIVED

PMID: 34008842 (View on PubMed)

Other Identifiers

H-37167

Identifier Type: -

Identifier Source: org_study_id