HypertensionPhase 2NCT01166165
Effect of Vitamin D Replacement During Winter Months in Patients With Hypertension
A Phase 2 study testing Cholecalciferol in people with Hypertension and Vitamin D Deficiency, run by Regional Hospital Holstebro at 1 site in Denmark.
Trial summary
High blood pressure is related to increased risk of cardiovascular disease and death, and accounts for approximately 8 mill deaths worldwide each year. Blood pressure exhibits a seasonal variation with a tendency to increase during winter months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Vitamin D Deficiency
- 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
- 136 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2010to Apr 2011
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Well-regulated arterial hypertension
- Office blood pressure > 120/70 mmHg
Who cannot join
- Pregnancy or nursing
- Cancer
- Alcohol abuse
- Continuous glucocorticoid or NSAID treatment
- 24-hour blood pressure > 150/95 mmHg
- Hypercalcemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Cholecalciferol on 24-hr ABPM and Vasoactive Hormones in Patients With Hypertension.
High blood pressure is related to increased risk of cardiovascular disease and death, and accounts for approximately 8 mill deaths worldwide each year. Blood pressure exhibits a seasonal variation with a tendency to increase during winter months. Vitamin D deficiency is more common during months where UVB radiation from the sun is absent, and vitamin D has been associated with high blood pressure. This study will evaluate the effect of vitamin D replacement during winter months on blood pressure and vasoactive hormones in patients with high blood pressure.
- Conditions
- Hypertension, Vitamin D Deficiency
- Being tested
- Cholecalciferol, Placebo
- Keywords
- Hypertension, blood pressure, vitamin d, winter, cholecalciferol, arterial stiffness, renin, angiotensin, aldosterone, calcium
- Medical subject headings
- Hypertension, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
3 tablets of 1000 IU daily for 20 weeks
PlaceboDrug
3 placebo tablets daily for 20 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cholecalciferol | Active comparator | Not described Receives: Drug: Cholecalciferol |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour systolic blood pressure
Measured: 20 weeks
Secondary outcomes (13)
Plasma renin concentration
Measured: 20 weeks
Plasma concentration of angiotensin II
Measured: 20 weeks
Plasma concentration of aldosterone
Measured: 20 weeks
Plasma concentration of c-reactive protein
Measured: 20 weeks
Urine albumin creatinine ratio
Measured: 20 weeks
Urine calcium creatinine ratio
Measured: 20 weeks
Plasma concentration of 25-hydroxycholecalciferol
Measured: 5 weeks
Serum concentration of FGF-23
Measured: 20 weeks
Augmentation index and central blood pressure
Measured: 20 weeks
Pulse wave velocity
Measured: 20 weeks
Heart rate variability
Measured: 20 weeks
Plasma concentration of ionized calcium
Measured: 5 weeks
Plasma concentration of phosphate
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionApr 2011
- Study completionApr 2011
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 HypertensionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regional Hospital Holstebro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erling Bjerregaard Pedersen, Regional Hospital Holstebro
- Investigators
- Thomas Larsen, M.D., Principal investigator, Departments of Medical Research, Holstebro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01166165
- Sponsor's protocol ID
- EBP-TL-2010-2
- Other IDs
- M-20100120
- Status last verified
- Jun 2012
- First submitted
- 19 Jul 2010
- Last updated
- 19 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Larsen T, Mose FH, Bech JN, Hansen AB, Pedersen EB. Effect of cholecalciferol supplementation during winter months in patients with hypertension: a randomized, placebo-controlled trial. Am J Hypertens. 2012 Nov;25(11):1215-22. doi: 10.1038/ajh.2012.111. Epub 2012 Aug 2.
PubMed 22854639
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cholecalciferol on 24-hr ABPM and Vasoactive Hormones in Patients With Hypertension.
- ClinicalTrials.gov ID
- NCT01166165
- Acronym / sponsor ID
- EBP-TL-2010-2
- Conditions
- Hypertension, Vitamin D Deficiency
- Keywords
- Hypertension, blood pressure, vitamin d, winter, cholecalciferol, arterial stiffness, renin, angiotensin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Regional Hospital HolstebroUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 20 Jul 2010 (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.
High blood pressure is related to increased risk of cardiovascular disease and death, and accounts for approximately 8 mill deaths worldwide each year. Blood pressure exhibits a seasonal variation with a tendency to increase during winter months. Vitamin D deficiency is more common during months where UVB radiation from the sun is absent, and vitamin D has been associated with high blood pressure. This study will evaluate the effect of vitamin D replacement during winter months on blood pressure and vasoactive hormones in patients with high blood pressure.
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 | Drug: Cholecalciferol |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Well-regulated arterial hypertension
- Office blood pressure > 120/70 mmHg
Key exclusion criteria (6 listed)
- Pregnancy or nursing
- Cancer
- Alcohol abuse
- Continuous glucocorticoid or NSAID treatment
- 24-hour blood pressure > 150/95 mmHg
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 |
|---|---|---|
| Cholecalciferol3 tablets of 1000 IU daily for 20 weeks | Drug | Cholecalciferol |
| Placebo3 placebo tablets daily for 20 weeks | Drug | Placebo |
Primary outcome
24-hour systolic blood pressure
Time frame: 20 weeks
13 secondary outcomes
Plasma renin concentration
Time frame: 20 weeks
Plasma concentration of angiotensin II
Time frame: 20 weeks
Plasma concentration of aldosterone
Time frame: 20 weeks
Plasma concentration of c-reactive protein
Time frame: 20 weeks
Urine albumin creatinine ratio
Time frame: 20 weeks
Urine calcium creatinine ratio
Time frame: 20 weeks
Plasma concentration of 25-hydroxycholecalciferol
Time frame: 5 weeks
Serum concentration of FGF-23
Time frame: 20 weeks
Augmentation index and central blood pressure
Time frame: 20 weeks
Pulse wave velocity
Time frame: 20 weeks
Heart rate variability
Time frame: 20 weeks
Plasma concentration of ionized calcium
Time frame: 5 weeks
Plasma concentration of phosphate
Time frame: 5 weeks
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 19 Jun 2012.
- Derived from this study: PubMed 22854639Larsen T, Mose FH, Bech JN, Hansen AB, Pedersen EB. Effect of cholecalciferol supplementation during winter months in patients with hypertension: a randomized, placebo-controlled trial. Am J Hypertens. 2012 Nov;25(11):1215-22. doi: 10.1038/ajh.2012.111. Epub 2012 Aug 2.
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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.
Thomas Larsen, M.D. principal investigator
Departments of Medical Research, Holstebro Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cholecalciferol in people with Hypertension and Vitamin D Deficiency, run by Regional Hospital Holstebro 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 2 inclusion and 6 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 19 Jun 2012. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
24-hour systolic blood pressure (time frame: 20 weeks). 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 NCT01166165, 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 19 Jun 2012.