25-Hydroxyvitamin D Pharmacokinetic Study

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Primary Purpose

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Calcifediol

Calciferol

About this trial

This is an interventional treatment trial for Vitamin D Deficiency focused on measuring Calcifediol (25(OH)D), Calciferol (Vitamin D)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Solomon Carter Fuller Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Fat-Mal, calcifediol then calciferol

Fat-Mal, calciferol then calcifediol

Non Fat-Mal, calcifediol then calciferol

Non Fat-Mal, calciferol then calcifediol

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT03401541

First Posted

January 10, 2018

Last Updated

June 2, 2020

Sponsor

Boston University

1. Study Identification

Unique Protocol Identification Number

NCT03401541

Brief Title

25-Hydroxyvitamin D Pharmacokinetic Study

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

October 1, 2018 (Actual)

Primary Completion Date

April 1, 2019 (Actual)

Study Completion Date

November 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boston University

4. Oversight

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

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitamin D Deficiency, Fat Malabsorption

Keywords

Calcifediol (25(OH)D), Calciferol (Vitamin D)

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Crossover Assignment

Model Description

Each arm will first receive 25(OH)D and then vitamin D or vitamin D and then 25(OH)D

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fat-Mal, calcifediol then calciferol

Arm Type

Experimental

Arm Description

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.

Arm Title

Fat-Mal, calciferol then calcifediol

Arm Type

Experimental

Arm Description

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.

Arm Title

Non Fat-Mal, calcifediol then calciferol

Arm Type

Experimental

Arm Description

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.

Arm Title

Non Fat-Mal, calciferol then calcifediol

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Calcifediol

Other Intervention Name(s)

25(OH)D

Intervention Description

One capsule of 900 micrograms of 25(OH)D

Intervention Type

Drug

Intervention Name(s)

Calciferol

Other Intervention Name(s)

Vitamin D

Intervention Description

One capsule of 900 micrograms of Vitamin D

Primary Outcome Measure Information:

Title

Change in Serum vitamin D status

Description

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

Title

Change in 25-Hydroxyvitamin D Status

Description

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

Secondary Outcome Measure Information:

Title

Serum Calcium Levels

Description

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