Pharmacokinetics of Calcifediol and Cholecalciferol

August 5, 2024 updated by: DSM Nutritional Products, Inc.

The Response of Serum 25-hydroxyvitamin D to Different Doses of Calcifediol Hy.D Compared to Vitamin D3 Supplementation: A Randomized, Controlled, Double Blind, Long Term Pharmacokinetic Study

The investigators are intending to perform a clinical study in healthy subjects on the pharmacokinetics of different doses of Hy.D Calcifediol compared to vitamin D3 (cholecalciferol) in order to gain insight into the dose response relationship and to assess kinetic differences including the steady state. The metabolites 1,25(OH)2D, 24,25(OH)2D will be assessed throughout the study to assess the metabolism of vitamin D vs. 25(OH)D. Vitamin D3 will be measured throughout the study to assess compliance with the restriction of exogenous vitamin D supplementation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Reaching consistent levels of 25(OH)D has been shown to be crucial in decreasing falls, fractures and increasing calcium absorption. One way to circumvent the variability of 25(OH)D response to vitamin D might be to use calcifediol supplementation and bypass the 25-hydroxylase enzyme entirely. This approach also permits the physician to achieve desired serum levels in a matter of just a few days, rather than the several weeks required when using native vitamin D. Compared to native vitamin D, calcifediol is more water soluble, has a shorter half-life and increases 25(OH)D levels more quickly. Calcifediol is also more potent, about 3.5 times more potent in raising 25(OH)D levels than vitamin D. Its water solubility may also confer an advantage in patients who have difficulty absorbing fat soluble vitamins. This form of vitamin D metabolite has been used historically to increase calcium absorption, treat osteomalacia, and increase Bone Mineral Density (BMD). Using calcifediol seems to be a practical solution, but little is known about the dose response variability in humans and how it compares to that of native vitamin D. The investigators are intending to perform a clinical study in healthy subjects on the pharmacokinetics of different doses of Hy.D Calcifediol compared to vitamin D3 (cholecalciferol) in order to gain insight into the dose response relationship and to assess kinetic differences including the steady state. The metabolites 1,25(OH)2D, 24,25(OH)2D will be assessed throughout the study to assess the metabolism of vitamin D vs. 25(OH)D. Vitamin D3 will be measured throughout the study to assess compliance with the restriction of exogenous vitamin D supplementation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
93

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy males >50 years in age
  • Healthy postmenopausal women >50 years in age, who have not experienced a menstrual bleeding for a minimum of 12 months
  • BMI between 20-32 kg/m2
  • Subject understands the study procedures and signs the informed consent to participate in the study
  • Subject has clear understanding of the English language
  • Caucasian ethnicity
  • Willingness to avoid direct sun exposure and to restrict travel to sunny climates during the whole study period.

Exclusion Criteria:

  • Subject has any health conditions that would prevent him/her from fulfilling the study requirements, put the subject at risk or would confound the interpretation of the study results as judged by the Principal Investigator
  • Subjects with a history of hypercalcemia (Serum calcium adjusted for albumin of > 2.6 nmol/l)
  • Supplemental calcium intake beyond 500 mg per day during the entire study and follow up
  • Any vitamin D supplementation within 2 months before the baseline blood draw and during the entire study and follow up
  • Subject has gastrointestinal malabsorption (from coeliac disease, colitis, surgery etc.)
  • Subject has kidney disease or liver disease
  • Medication: Bisphosphonate or Parathyroid Hormone (PTH) treatment, use of steroids in any form, anticonvulsants, antibiotics, antipsychotics, use of any drug that alters fat absorption, e.g. Xenical (Ali).
  • Use of Hormone Replacement Therapy (HRT) within the previous 6 months
  • Subject has signs of acute or severe illness (i.e. unintentional weight loss, night sweats etc.)
  • Subject has a known allergy or sensitivity to the investigational products or any ingredients of the investigational products
  • Subject heavily consumes alcohol containing products defined as greater than (>) 3 drinks for men or 2 drinks for women (1 drink is 11 grams of alcohol or equivalence of 12 oz beer, 5 oz wine, or 1.5 oz distilled spirits) of alcoholic beverages per day
  • Subject has donated more than 300 mL of blood during the last three months prior to screening
  • Participating in another clinical trial
  • Women who are premenopausal
  • Subjects with active current psychiatric illness or condition which is likely to interfere with the subject's ability to understand the requirements of the biomedical research project
  • Sunbed users will be excluded from the study.
  • (Expected) increase in exposure to sunlight (e.g. a planned holiday of more than eight days, a beach holiday or a holiday outside Europe) in the study period of day 01 until day 28.

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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 25(OH)D3 (Calcifediol Hy.D) 10 mcg
25(OH)D3 (Calcifediol Hy.D), Dose: 10 mcg, 1 capsule/day before breakfast, Duration: 6 months
Dietary supplement: 25(OH)D3 (Calcifediol Hy.D) 10 mcg
25(OH)D3 (Calcifediol Hy.D)
Experimental: 25(OH)D3 (Calcifediol Hy.D) 15 mcg
25(OH)D3 (Calcifediol Hy.D), Dose: 15 mcg, 1 capsule/day before breakfast, Duration: 6 months
Dietary supplement: 25(OH)D3 (Calcifediol Hy.D) 15 mcg
25(OH)D3 (Calcifediol Hy.D)
Experimental: 25(OH)D3 (Calcifediol Hy.D) 20 mcg
25(OH)D3 (Calcifediol Hy.D), Dose: 20 mcg, 1 capsule/day before breakfast, Duration: 6 months
Dietary supplement: 25(OH)D3 (Calcifediol Hy.D) 20 mcg
25(OH)D3 (Calcifediol Hy.D)
Active Comparator: Vitamin D3 (Cholecalciferol) 20 mcg
Vitamin D3 (Cholecalciferol), Dose: 20 mcg, 1 capsule/day before breakfast, Duration: 6 months
Dietary supplement: Vitamin D3 (Cholecalciferol) 20 mcg
Vitamin D3 (Cholecalciferol)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Plasma 25(OH)D concentration at several visits
Time Frame: 6 months
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
AUC(day1-day183) of 25(OH)D, 1,25(OH)2D, 24,25(OH)2D and vitamin D
Time Frame: 6 months
6 months
AUC(day1), Cmax(day1), Tmax(day1) and AUC(day182), Cmax(day182), Tmax(day182) of 25(OH)D, 1,25(OH)2D, 24,25(OH)2D and vitamin D
Time Frame: 6 months
6 months
Time point at which the plasma level of ≥75 nmol/L 25(OH)D is reached (t)
Time Frame: 6 months
6 months
Elimination rate and half-life of of 25(OH)D, 1,25(OH)2D, 24,25(OH)2D and vitamin D after cessation of supplementation
Time Frame: 6 months
6 months
Serum calcium and creatinine, albumin, PTH, urine calcium and creatinine and vital signs throughout the study, (Serious) Adverse event assessment and reporting
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
DSM Nutritional Products, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Leatherhead Food Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sarah Hull, MSc, Leatherhead Food Research

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 20, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 7, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2013-04-17-HDPK
  • 127927 (Other Identifier: Leatherhead Food Research)

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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