OsteoporosisNCT02333682
Pharmacokinetics of Calcifediol and Cholecalciferol
A study testing 25(OH)D3 (Calcifediol Hy.D) 10 mcg, 25(OH)D3 (Calcifediol Hy.D) 15 mcg and 25(OH)D3 (Calcifediol Hy.D) 20 mcg in people with Osteoporosis, run by dsm-firmenich Switzerland AG.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- 25(OH)D3 (Calcifediol Hy.D) 10 mcg, 25(OH)D3 (Calcifediol Hy.D) 15 mcg and 25(OH)D3 (Calcifediol Hy.D) 20 mcg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoporosis
- Being tested
- 25(OH)D3 (Calcifediol Hy.D) 10 mcg, 25(OH)D3 (Calcifediol Hy.D) 15 mcg, 25(OH)D3 (Calcifediol Hy.D) 20 mcg, Vitamin D3 (Cholecalciferol) 20 mcg
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
25(OH)D3 (Calcifediol Hy.D) 10 mcgDietary supplement
25(OH)D3 (Calcifediol Hy.D)
25(OH)D3 (Calcifediol Hy.D) 15 mcgDietary supplement
25(OH)D3 (Calcifediol Hy.D)
25(OH)D3 (Calcifediol Hy.D) 20 mcgDietary supplement
25(OH)D3 (Calcifediol Hy.D)
Vitamin D3 (Cholecalciferol) 20 mcgDietary supplement
Vitamin D3 (Cholecalciferol)
| Study group | Role | What they receive |
|---|---|---|
| 25(OH)D3 (Calcifediol Hy.D) 10 mcg | Experimental | 25(OH)D3 (Calcifediol Hy.D), Dose: 10 mcg, 1 capsule/day before breakfast, Duration: 6 months Receives: Dietary Supplement: 25(OH)D3 (Calcifediol Hy.D) 10 mcg |
| 25(OH)D3 (Calcifediol Hy.D) 15 mcg | Experimental | 25(OH)D3 (Calcifediol Hy.D), Dose: 15 mcg, 1 capsule/day before breakfast, Duration: 6 months Receives: Dietary Supplement: 25(OH)D3 (Calcifediol Hy.D) 15 mcg |
| 25(OH)D3 (Calcifediol Hy.D) 20 mcg | Experimental | 25(OH)D3 (Calcifediol Hy.D), Dose: 20 mcg, 1 capsule/day before breakfast, Duration: 6 months Receives: Dietary Supplement: 25(OH)D3 (Calcifediol Hy.D) 20 mcg |
| Vitamin D3 (Cholecalciferol) 20 mcg | Active comparator | Vitamin D3 (Cholecalciferol), Dose: 20 mcg, 1 capsule/day before breakfast, Duration: 6 months Receives: Dietary Supplement: Vitamin D3 (Cholecalciferol) 20 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma 25(OH)D concentration at several visits
Measured: 6 months
Secondary outcomes (5)
AUC(day1-day183) of 25(OH)D, 1,25(OH)2D, 24,25(OH)2D and vitamin D
Measured: 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
Measured: 6 months
Time point at which the plasma level of ≥75 nmol/L 25(OH)D is reached (t)
Measured: 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
Measured: 6 months
Serum calcium and creatinine, albumin, PTH, urine calcium and creatinine and vital signs throughout the study, (Serious) Adverse event assessment and reporting
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study startNov 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- dsm-firmenich Switzerland AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Leatherhead Food Research
- Responsible party
- Sponsor
- Investigators
- Sarah Hull, MSc, Principal investigator, Leatherhead Food Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02333682
- Sponsor's protocol ID
- 2013-04-17-HDPK
- Other IDs
- 127927
- Status last verified
- Aug 2024
- First submitted
- 20 Oct 2014
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Graeff-Armas LA, Bendik I, Kunz I, Schoop R, Hull S, Beck M. Supplemental 25-Hydroxycholecalciferol Is More Effective than Cholecalciferol in Raising Serum 25-Hydroxyvitamin D Concentrations in Older Adults. J Nutr. 2020 Jan 1;150(1):73-81. doi: 10.1093/jn/nxz209.
PubMed 31518424
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02333682
- Acronym / sponsor ID
- 2013-04-17-HDPK
- Conditions
- Osteoporosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- dsm-firmenich Switzerland AGIndustry (pharma, biotech, devices)
- Collaborators
- Leatherhead Food Research
- Study start
- Nov 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 7 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 25(OH)D3 (Calcifediol Hy.D) 10 mcg | Experimental | Dietary Supplement: 25(OH)D3 (Calcifediol Hy.D) 10 mcg25(OH)D3 (Calcifediol Hy.D), Dose: 10 mcg, 1 capsule/day before breakfast, Duration: 6 months |
| 25(OH)D3 (Calcifediol Hy.D) 15 mcg | Experimental | Dietary Supplement: 25(OH)D3 (Calcifediol Hy.D) 15 mcg25(OH)D3 (Calcifediol Hy.D), Dose: 15 mcg, 1 capsule/day before breakfast, Duration: 6 months |
| 25(OH)D3 (Calcifediol Hy.D) 20 mcg | Experimental | Dietary Supplement: 25(OH)D3 (Calcifediol Hy.D) 20 mcg25(OH)D3 (Calcifediol Hy.D), Dose: 20 mcg, 1 capsule/day before breakfast, Duration: 6 months |
| Vitamin D3 (Cholecalciferol) 20 mcg | Active comparator | Dietary Supplement: Vitamin D3 (Cholecalciferol) 20 mcgVitamin D3 (Cholecalciferol), Dose: 20 mcg, 1 capsule/day before breakfast, Duration: 6 months |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (17 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 25(OH)D3 (Calcifediol Hy.D) 10 mcg25(OH)D3 (Calcifediol Hy.D) | Dietary supplement | 25(OH)D3 (Calcifediol Hy.D) 10 mcg |
| 25(OH)D3 (Calcifediol Hy.D) 15 mcg25(OH)D3 (Calcifediol Hy.D) | Dietary supplement | 25(OH)D3 (Calcifediol Hy.D) 15 mcg |
| 25(OH)D3 (Calcifediol Hy.D) 20 mcg25(OH)D3 (Calcifediol Hy.D) | Dietary supplement | 25(OH)D3 (Calcifediol Hy.D) 20 mcg |
| Vitamin D3 (Cholecalciferol) 20 mcgVitamin D3 (Cholecalciferol) | Dietary supplement | Vitamin D3 (Cholecalciferol) 20 mcg |
Primary outcome
Plasma 25(OH)D concentration at several visits
Time frame: 6 months
5 secondary outcomes
AUC(day1-day183) of 25(OH)D, 1,25(OH)2D, 24,25(OH)2D and vitamin D
Time frame: 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
Time point at which the plasma level of ≥75 nmol/L 25(OH)D is reached (t)
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Derived from this study: PubMed 31518424Graeff-Armas LA, Bendik I, Kunz I, Schoop R, Hull S, Beck M. Supplemental 25-Hydroxycholecalciferol Is More Effective than Cholecalciferol in Raising Serum 25-Hydroxyvitamin D Concentrations in Older Adults. J Nutr. 2020 Jan 1;150(1):73-81. doi: 10.1093/jn/nxz209.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Hull, MSc principal investigator
Leatherhead Food Research
Questions about this trial
What is this clinical trial studying?
A study testing 25(OH)D3 (Calcifediol Hy.D) 10 mcg, 25(OH)D3 (Calcifediol Hy.D) 15 mcg and 25(OH)D3 (Calcifediol Hy.D) 20 mcg in people with Osteoporosis, run by dsm-firmenich Switzerland AG.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma 25(OH)D concentration at several visits (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02333682, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.