25-Hydroxyvitamin D Pharmacokinetic Study

June 2, 2020 updated by: Boston University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Solomon Carter Fuller Mental Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Calcifediol
One capsule of 900 micrograms of 25(OH)D
Other Names:
  • 25(OH)D
Drug: Calciferol
One capsule of 900 micrograms of Vitamin D
Other Names:
  • Vitamin D
Experimental: 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.
Drug: Calcifediol
One capsule of 900 micrograms of 25(OH)D
Other Names:
  • 25(OH)D
Drug: Calciferol
One capsule of 900 micrograms of Vitamin D
Other Names:
  • Vitamin D
Experimental: 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.
Drug: Calcifediol
One capsule of 900 micrograms of 25(OH)D
Other Names:
  • 25(OH)D
Drug: Calciferol
One capsule of 900 micrograms of Vitamin D
Other Names:
  • Vitamin D
Experimental: 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.
Drug: Calcifediol
One capsule of 900 micrograms of 25(OH)D
Other Names:
  • 25(OH)D
Drug: Calciferol
One capsule of 900 micrograms of Vitamin D
Other Names:
  • Vitamin D

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Serum vitamin D status
Time Frame: 2 weeks after administration
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
Change in 25-Hydroxyvitamin D Status
Time Frame: 2 weeks after administration
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Calcium Levels
Time Frame: Baseline and completion of each intervention period (2 weeks)
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)
Serum Phosphorus Levels
Time Frame: Baseline and completion of each intervention period (2 weeks)
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)
Serum Albumin Levels
Time Frame: Baseline and completion of each intervention period (2 weeks)
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)
Serum Creatinine levels
Time Frame: Baseline and completion of each intervention period (2 weeks)
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)
Serum intact parathyroid hormone levels
Time Frame: Baseline and completion of each intervention period (2 weeks)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston University

Investigators

  • Principal Investigator: Michael F Holick, MD, PhD, Boston University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

January 10, 2018

First Submitted That Met QC Criteria

January 16, 2018

First Posted (Actual)

January 17, 2018

Study Record Updates

Last Update Posted (Actual)

June 4, 2020

Last Update Submitted That Met QC Criteria

June 2, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-37167

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data will be available upon reasonable request to mfholick@bu.edu.

IPD Sharing Time Frame

Beginning 9 month and ending 36 months following article publication.

IPD Sharing Access Criteria

Investigators whose proposed use of the data has been approved by the current study principal investigators.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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