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25-Hydroxyvitamin D Pharmacokinetic Study

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ClinicalTrials.gov Identifier: NCT03401541
Recruitment Status : Recruiting
First Posted : January 17, 2018
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Boston University

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.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Fat Malabsorption Drug: Calcifediol Drug: Calciferol Early Phase 1

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  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Each arm will first receive 25(OH)D and then vitamin D or vitamin D and then 25(OH)D
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


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 Name: 25(OH)D

Drug: Calciferol
One capsule of 900 micrograms of Vitamin D
Other Name: 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 Name: 25(OH)D

Drug: Calciferol
One capsule of 900 micrograms of Vitamin D
Other Name: 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 Name: 25(OH)D

Drug: Calciferol
One capsule of 900 micrograms of Vitamin D
Other Name: 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 Name: 25(OH)D

Drug: Calciferol
One capsule of 900 micrograms of Vitamin D
Other Name: Vitamin D




Primary Outcome Measures :
  1. 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. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03401541


Contacts
Contact: Michael F Holick, PhD, MD 6176384546 Mfholick@bu.edu
Contact: Grace Yoon, BA 6176384546 Ghyoon@bu.edu

Locations
United States, Massachusetts
Solomon Carter Fuller Mental Health Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Michael F Holick, MD, PhD    617-638-4546    mfholick@bu.edu   
Sponsors and Collaborators
Boston University
Investigators
Principal Investigator: Michael F Holick, MD, PhD Boston University

Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT03401541     History of Changes
Other Study ID Numbers: H-37167
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Boston University:
Calcifediol (25(OH)D)
Calciferol (Vitamin D)

Additional relevant MeSH terms:
Malabsorption Syndromes
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases
Vitamins
Vitamin D
Ergocalciferols
Hydroxycholecalciferols
Calcifediol
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents