HealthyNCT00952562
The Influence of Vitamin D on Mineral Metabolism, Blood Pressure and Pulse Wave Analysis in Healthy Individuals
A study testing cholecalciferol in people with Healthy, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
A randomized placebo controlled trial evaluating the effect of the recently recommended high doses of cholecalciferol (3000 IU/day) on mineral metabolism, blood pressure and pulse wave analysis in healthy individuals. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2009to Jun 2011
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- > 18 years old
- p 25OH vitaminD<50nmol/l
- signed informed consent
Who cannot join
- receiving antihypertensive or antidiabetic treatment
- sarcoidoses
- history of kidney stones
- receiving 1-alfa-hydroxylated vitamin D treatment
- plasma creatinin > 120 micromol/l
- ionised calcium > 1,5 mmol/l
Show all 14Show fewer
- treatment with calcimimetics
- active malignancy
- intestinal malabsorption
- active pancreatitis
- former hospitalisation due to alcoholic related disease
- using euphoriant drugs
- pregnancy or risk of being pregnant or lactating women
- Known allergy to cholecalciferol capsules
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Vitamin D on Mineral Metabolism, Blood Pressure and Pulse Wave Analysis in Healthy Individuals. A Randomised Double Blinded Placebo Controlled Trial.
A randomized placebo controlled trial evaluating the effect of the recently recommended high doses of cholecalciferol (3000 IU/day) on mineral metabolism, blood pressure and pulse wave analysis in healthy individuals.
- Conditions
- Healthy
- Being tested
- cholecalciferol, placebo
- Keywords
- vitamin d, calcium, blood pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cholecalciferolDietary supplement
Also called D3-Vitamin
Capsule cholecalciferol 1000 IU, 3 capsules per day for 16 weeks
placeboDietary supplement
Empty capsules, 3 capsules per day for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| cholecalciferol | Active comparator | 3000 IU cholecalciferol per day for 16 weeks Receives: Dietary Supplement: cholecalciferol |
| placebo | Placebo comparator | Not described Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
urinary calcium excretion
Measured: before and after 16 weeks of intervention
Secondary outcomes (14)
25 hydroxyvitamin D
Measured: before and after 16 weeks og treatment
1,25 dihydroxyvitamin D
Measured: before and after 16 weeks of treatment
urinary creatinin
Measured: before and after 16 weeks of treatment
urinary protein
Measured: before and after 16 weeks of treatment
urinary phosphorous
Measured: before and after 16 weeks of treatment
p-FGF23
Measured: before and after 16 weeks of treatment
blood pressure
Measured: before and after 16 weeks of treatment
pulse wave velocity
Measured: before and after 16 weeks of treatment
augmentation index
Measured: before and after 16 weeks of treatment
central blood pressure
Measured: before and after 16 weeks of treatment
p-phosphate
Measured: before and after 16 weeks of treatment
ionised p-calcium
Measured: before and after 16 weeks of treatment
p-iPTH
Measured: before and after 16 weeks of treatment
alkalic phosphatase
Measured: before and after 16 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ditte Hansen, MD, Principal investigator, Zealand University HospitalNiels Erik Frandsen, MD, Principal investigator, Zealand University HospitalKnud Rasmussen, DmSci, Principal investigator, Zealand University HospitalLisbet Brandi, DmSci, Principal investigator, Zealand University HospitalHans Christian Hoeck, DmSci, Principal investigator, Center for clinical and basic research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00952562
- Sponsor's protocol ID
- 7. juli 2009, version 1
- Status last verified
- Aug 2011
- First submitted
- 3 Aug 2009
- Last updated
- 24 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Bressendorff I, Brandi L, Schou M, Nygaard B, Frandsen NE, Rasmussen K, Odum L, Ostergaard OV, Hansen D. The Effect of High Dose Cholecalciferol on Arterial Stiffness and Peripheral and Central Blood Pressure in Healthy Humans: A Randomized Controlled Trial. PLoS One. 2016 Aug 10;11(8):e0160905. doi: 10.1371/journal.pone.0160905. eCollection 2016.
PubMed 27509187Nygaard B, Frandsen NE, Brandi L, Rasmussen K, Oestergaard OV, Oedum L, Hoeck HC, Hansen D. Effects of high doses of cholecalciferol in normal subjects: a randomized double-blinded, placebo-controlled trial. PLoS One. 2014 Aug 28;9(8):e102965. doi: 10.1371/journal.pone.0102965. eCollection 2014.
PubMed 25166750
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Vitamin D on Mineral Metabolism, Blood Pressure and Pulse Wave Analysis in Healthy Individuals. A Randomised Double Blinded Placebo Controlled Trial.
- ClinicalTrials.gov ID
- NCT00952562
- Acronym / sponsor ID
- 7. juli 2009, version 1
- Conditions
- Healthy
- Keywords
- vitamin d, calcium, blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 6 Aug 2009 (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.
A randomized placebo controlled trial evaluating the effect of the recently recommended high doses of cholecalciferol (3000 IU/day) on mineral metabolism, blood pressure and pulse wave analysis in healthy individuals.
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 |
|---|---|---|
| cholecalciferol | Active comparator | Dietary Supplement: cholecalciferol3000 IU cholecalciferol per day for 16 weeks |
| placebo | Placebo comparator | Dietary Supplement: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- > 18 years old
- p 25OH vitaminD<50nmol/l
- signed informed consent
Key exclusion criteria (14 listed)
- receiving antihypertensive or antidiabetic treatment
- sarcoidoses
- history of kidney stones
- receiving 1-alfa-hydroxylated vitamin D treatment
- plasma creatinin > 120 micromol/l
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 |
|---|---|---|
| cholecalciferolAlso: D3-VitaminCapsule cholecalciferol 1000 IU, 3 capsules per day for 16 weeks | Dietary supplement | cholecalciferol |
| placeboEmpty capsules, 3 capsules per day for 16 weeks | Dietary supplement | placebo |
Primary outcome
urinary calcium excretion
Time frame: before and after 16 weeks of intervention
14 secondary outcomes
25 hydroxyvitamin D
Time frame: before and after 16 weeks og treatment
1,25 dihydroxyvitamin D
Time frame: before and after 16 weeks of treatment
urinary creatinin
Time frame: before and after 16 weeks of treatment
urinary protein
Time frame: before and after 16 weeks of treatment
urinary phosphorous
Time frame: before and after 16 weeks of treatment
p-FGF23
Time frame: before and after 16 weeks of treatment
blood pressure
Time frame: before and after 16 weeks of treatment
pulse wave velocity
Time frame: before and after 16 weeks of treatment
augmentation index
Time frame: before and after 16 weeks of treatment
central blood pressure
Time frame: before and after 16 weeks of treatment
p-phosphate
Time frame: before and after 16 weeks of treatment
ionised p-calcium
Time frame: before and after 16 weeks of treatment
p-iPTH
Time frame: before and after 16 weeks of treatment
alkalic phosphatase
Time frame: before and after 16 weeks of treatment
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 24 Aug 2011.
- Derived from this study: PubMed 27509187Bressendorff I, Brandi L, Schou M, Nygaard B, Frandsen NE, Rasmussen K, Odum L, Ostergaard OV, Hansen D. The Effect of High Dose Cholecalciferol on Arterial Stiffness and Peripheral and Central Blood Pressure in Healthy Humans: A Randomized Controlled Trial. PLoS One. 2016 Aug 10;11(8):e0160905. doi: 10.1371/journal.pone.0160905. eCollection 2016.
- Derived from this study: PubMed 25166750Nygaard B, Frandsen NE, Brandi L, Rasmussen K, Oestergaard OV, Oedum L, Hoeck HC, Hansen D. Effects of high doses of cholecalciferol in normal subjects: a randomized double-blinded, placebo-controlled trial. PLoS One. 2014 Aug 28;9(8):e102965. doi: 10.1371/journal.pone.0102965. eCollection 2014.
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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.
Ditte Hansen, MD principal investigator
Zealand University Hospital
Niels Erik Frandsen, MD principal investigator
Zealand University Hospital
Knud Rasmussen, DmSci principal investigator
Zealand University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cholecalciferol in people with Healthy, run by Zealand University Hospital at 1 site in Denmark.
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 3 inclusion and 14 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 24 Aug 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
urinary calcium excretion (time frame: before and after 16 weeks of intervention). 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 NCT00952562, which also lists 2 linked publications.
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 24 Aug 2011.