- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02333682
Pharmacokinetics of Calcifediol and Cholecalciferol
April 12, 2016 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
Completed
Conditions
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
Interventional
Enrollment (Actual)
93
Phase
- 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
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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 |
Intervention / Treatment |
---|---|
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
|
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
|
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
|
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
|
Vitamin D3 (Cholecalciferol)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma 25(OH)D concentration at several visits
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
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
Collaborators
Investigators
- 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.
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
November 1, 2014
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
October 20, 2014
First Submitted That Met QC Criteria
January 5, 2015
First Posted (Estimate)
January 7, 2015
Study Record Updates
Last Update Posted (Estimate)
April 13, 2016
Last Update Submitted That Met QC Criteria
April 12, 2016
Last Verified
January 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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