HealthyPhase 1NCT00718276
Pharmacokinetic Study: Effect of 25(OH)D and Vitamin D3 on Serum 25(OH)D
A Phase 1 study testing 25(OH)D and vitamin D3 in people with Healthy, run by University of Zurich at 1 site in Switzerland.
Trial summary
We compare the effect of HyD (25-hydroxyvitamin D) and vitamin D3 in their effect on 25-hydroxyvitamin D plasma levels over a course of 4 month. This is a pharmacokinetic study including 35 postmenopausal women. Trial with medicinal product Read more about this study
- Who is it for?
- Ages 50 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 25(OH)D and vitamin D3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2008to Sep 2008
- Phase
- Phase 1
- 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 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal women
- Age 50 to 75 years
- Body mass index 18-29 kg/m2
- 25-hydroxyvitamin D levels 20 to 60 nmol/l
- Caucasian
- Generally healthy
Who cannot join
- Serum calcium > 2.6 nmol/L
- Use if dietary supplements (> 400 IU vitamin D per day, > 600 mg of calcium per day)
- Hypertension
- Diseases that carry the risk of hypercalcemia
- Use of any drug that interferes with bone metabolism in the last 12 months (bisphosphonates estrogen receptor modulators, PTH, calcitonin)
- Oral HRT in the last 6 months
Show all 13Show fewer
- Extreme diets
- Fracture or fall in the last 3 months
- Current smoking or alcohol abuse
- Planning on a sunny vacation in the course of the trial
- Kidney stone history
- Creatinine clearance < 30 ml/min
- Co-medications: anticoagulants, PTH, corticosteroids, thiazide diuretics, digoxin, anticonvulsants, malabsorption,z C
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Centre on Aging and Mobility
Zurich, Canton of Zurich, 8091
About this study
Official title: Pharmacokinetic Study in Healthy Postmenopausal Women to Compare Supplementation of Vitamin D3 to 25(OH)D
We compare the effect of HyD (25-hydroxyvitamin D) and vitamin D3 in their effect on 25-hydroxyvitamin D plasma levels over a course of 4 month. This is a pharmacokinetic study including 35 postmenopausal women.
- Trial with medicinal product
Read the detailed description
We include postmenopausal women age 50 to 75, race/ethnicity: Caucasian, serum 25(OH)D at baseline between 20 to 60 nmol/l, body mass index: < 30 kg/m2
to compare 25(OH)D and vitamin D3 in equimolar doses over a 4 month pharmacokinetic trial. The dosing arms are daily, weekly, and bolus
- Conditions
- Healthy
- Being tested
- 25(OH)D, vitamin D3
- Keywords
- Healthy postmenopausal women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
25(OH)DDrug
Also called HyD
daily (20ug), weekly (140 ug), Bolus (140 ug)
vitamin D3Dietary supplement
Also called Cholecalciferol
daily (800 IU), weekly (5600 IU), Bolus (5600 Iu)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 25(OH)D Receives: Drug: 25(OH)D |
| 2 | Active comparator | vitamin D3 Receives: Dietary Supplement: vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum 25(OH)D levels
Measured: repeated assessments over 4 months
Secondary outcomes (1)
muscle strength, blood pressure, blood glucose, bone markers
Measured: repeated assessments over 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2008 (estimated)
- Study startMar 2008
- Primary completionAug 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heike Bischoff Ferrari, MD, MPH, Principal investigator, University Hospital Zurich, Centre on Aging and Mobility
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00718276
- Sponsor's protocol ID
- 2007-09-13-HyD
- Status last verified
- Dec 2011
- First submitted
- 17 Jul 2008
- Last updated
- 23 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study in Healthy Postmenopausal Women to Compare Supplementation of Vitamin D3 to 25(OH)D
- ClinicalTrials.gov ID
- NCT00718276
- Acronym / sponsor ID
- 2007-09-13-HyD
- Conditions
- Healthy
- Keywords
- Healthy postmenopausal women
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 18 Jul 2008 (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.
We compare the effect of HyD (25-hydroxyvitamin D) and vitamin D3 in their effect on 25-hydroxyvitamin D plasma levels over a course of 4 month. This is a pharmacokinetic study including 35 postmenopausal women.
- Trial with medicinal product
Detailed description
We include postmenopausal women age 50 to 75, race/ethnicity: Caucasian, serum 25(OH)D at baseline between 20 to 60 nmol/l, body mass index: < 30 kg/m2
to compare 25(OH)D and vitamin D3 in equimolar doses over a 4 month pharmacokinetic trial. The dosing arms are daily, weekly, and bolus
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: 25(OH)D25(OH)D |
| 2 | Active comparator | Dietary Supplement: vitamin D3vitamin D3 |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Postmenopausal women
- Age 50 to 75 years
- Body mass index 18-29 kg/m2
- 25-hydroxyvitamin D levels 20 to 60 nmol/l
- Caucasian
Key exclusion criteria (13 listed)
- Serum calcium > 2.6 nmol/L
- Use if dietary supplements (> 400 IU vitamin D per day, > 600 mg of calcium per day)
- Hypertension
- Diseases that carry the risk of hypercalcemia
- Use of any drug that interferes with bone metabolism in the last 12 months (bisphosphonates estrogen receptor modulators, PTH, calcitonin)
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)DAlso: HyDdaily (20ug), weekly (140 ug), Bolus (140 ug) | Drug | 1 |
| vitamin D3Also: Cholecalciferoldaily (800 IU), weekly (5600 IU), Bolus (5600 Iu) | Dietary supplement | 2 |
Primary outcome
serum 25(OH)D levels
Time frame: repeated assessments over 4 months
1 secondary outcome
muscle strength, blood pressure, blood glucose, bone markers
Time frame: repeated assessments over 4 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 23 Dec 2011.
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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.
Heike Bischoff Ferrari, MD, MPH principal investigator
University Hospital Zurich, Centre on Aging and Mobility
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 25(OH)D and vitamin D3 in people with Healthy, run by University of Zurich at 1 site in Switzerland.
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 6 inclusion and 13 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 23 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
serum 25(OH)D levels (time frame: repeated assessments over 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Dec 2011.