Arterial HypertensionPhase 4NCT02136771
Styrian Vitamin D Hypertension Trial
A Phase 4 study testing Vitamin D3 in people with Arterial Hypertension and Vitamin D Deficiency, run by Medical University of Graz at 1 site in Austria.
Trial summary
In this randomized, double-blind, placebo-controlled trial we plan to enrol 200 vitamin D deficient hypertensive patients. Our main objective is to evaluate whether vitamin D3 supplementation with 2,800 IU daily for 8 weeks has an effect on 24-hour systolic ambulatory blood pressure (ABP) compared to placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterial Hypertension, Vitamin D Deficiency
- What is being tested?
- Vitamin D3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2011to Aug 2014
- Phase
- Phase 4
- 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
- 25-hydroxyvitamin D levels below 30 ng/ml (75 nmol/L)
- Arterial hypertension defined according to recent guidelines as an average office blood pressure on at least two occasions of systolic ≥ 140 and/or diastolic ≥ 90 mmHg or a mean 24-hour ABP of systolic ≥ 125 and/or diastolic ≥ 80, or a home blood pressure of systolic ≥ 130 and/or diastolic ≥ 85 or ongoing antihypertensive treatment which was initiated due to arterial hypertension
- Age of ≥ 18 years
- Written informed consent.
Who cannot join
- Hypercalcemia defined a serum calcium >2.65 mmol/L
- Pregnancy or lactating women
- Drug intake as part of another clinical study
- Acute coronary syndrome or cerebrovascular events in the previous 2 weeks
- Glomerular filtration rate (GFR) according to the MDRD formula < 15 ml/min/1.73m²
- Systolic 24-hour ABP > 160 mm Hg or < 120 mm Hg
Show all 12Show fewer
- Diastolic 24-hour ABP > 100 mm Hg
- Change of antihypertensive treatment (drugs and/or lifestyle) in the previous 4 weeks or planned changes of antihypertensive treatment during the study
- Any disease with an estimated life expectancy below 1 year
- Any clinically significant acute disease requiring drug treatment
- Chemotherapy or radiation therapy during the study
- Regular intake of more than 880 International Units (IU) vitamin D per day in the last four weeks before study entry or during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Styrian Vitamin D Hypertension Trial: A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Effects of Vitamin D Supplementation on Systolic Ambulatory Blood Pressure in Vitamin D Deficient Hypertensive Patients
In this randomized, double-blind, placebo-controlled trial we plan to enrol 200 vitamin D deficient hypertensive patients. Our main objective is to evaluate whether vitamin D3 supplementation with 2,800 IU daily for 8 weeks has an effect on 24-hour systolic ambulatory blood pressure (ABP) compared to placebo. In addition, we also aim to evaluate whether vitamin D3 supplementation alters 24-hour diastolic ABP, pulse wave velocity, N-terminal-pro-brain natriuretic peptide (NT-pro-BNP), corrected QT interval (Bazett formula), renin, aldosterone, 24-hour urinary albumin excretion, HOMA-IR (HOmeostatic Model Assessment: Insulin Resistance), triglycerides and HDL-cholesterol.
- Conditions
- Arterial Hypertension, Vitamin D Deficiency
- Being tested
- Vitamin D3, Placebo
- 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.
Vitamin D3Dietary supplement
The treatment group receives 2,800 IU vitamin D3 per day as oily drops (Oleovit D3, producer: Fresenius Kabi Austria, A-8055 Graz) for 8 weeks
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 | Active comparator | The treatment group receives 2,800 IU vitamin D3 per day as oily drops (Oleovit D3; producer: Fresenius Kabi Austria, A-8055 Graz) for 8 weeks Receives: Dietary Supplement: Vitamin D3 |
| Placebo | Placebo comparator | Oily drops as placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour systolic ambulatory blood pressure
Measured: 8 weeks
Secondary outcomes (10)
24-hour diastolic ambulatory blood pressure
Measured: 8 weeks
N-terminal-pro-brain natriuretic peptide (NT-pro-BNP)
Measured: 8 weeks
corrected QT interval (Bazett formula)
Measured: 8 weeks
Renin
Plasma renin concentration
Measured: 8 weeks
Aldosterone
Plasma aldosterone concentration
Measured: 8 weeks
24-hour urinary albumin excretion
Measured: 8 weeks
HOMA-IR
HOMA-IR (HOmeostatic Model Assessment: Insulin Resistance)
Measured: 8 weeks
Triglycerides
Measured: 8 weeks
HDL-cholesterol
Measured: 8 weeks
Pulse wave velocity
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startJun 2011
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Arterial 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Pilz, MD, PhD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136771
- Sponsor's protocol ID
- EudraCT no:2009-018125-70
- Other IDs
- 2009-018125-70, 2009
- Status last verified
- Nov 2014
- First submitted
- 9 May 2014
- Last updated
- 25 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Grubler MR, Zittermann A, Verheyen ND, Trummer C, Theiler-Schwetz V, Keppel MH, Malle O, Richtig G, Gangler S, Bischoff-Ferrari H, Scharnagl H, Meinitzer A, Marz W, Tomaschitz A, Pilz S. Randomized trial of vitamin D versus placebo supplementation on markers of systemic inflammation in hypertensive patients. Nutr Metab Cardiovasc Dis. 2021 Oct 28;31(11):3202-3209. doi: 10.1016/j.numecd.2021.07.028. Epub 2021 Aug 18.
PubMed 34629245Grubler MR, Gaksch M, Kienreich K, Verheyen ND, Schmid J, Mullner C, Richtig G, Scharnagl H, Trummer C, Schwetz V, Meinitzer A, Pieske B, Marz W, Tomaschitz A, Pilz S. Effects of Vitamin D3 on asymmetric- and symmetric dimethylarginine in arterial hypertension. J Steroid Biochem Mol Biol. 2018 Jan;175:157-163. doi: 10.1016/j.jsbmb.2016.12.014. Epub 2016 Dec 24.
PubMed 28027911Grubler MR, Gaksch M, Kienreich K, Verheyen N, Schmid J, O Hartaigh BW, Richtig G, Scharnagl H, Meinitzer A, Pieske B, Fahrleitner-Pammer A, Marz W, Tomaschitz A, Pilz S. Effects of Vitamin D Supplementation on Plasma Aldosterone and Renin-A Randomized Placebo-Controlled Trial. J Clin Hypertens (Greenwich). 2016 Jul;18(7):608-13. doi: 10.1111/jch.12825. Epub 2016 Apr 21.
PubMed 27098193Ernst JB, Tomaschitz A, Grubler MR, Gaksch M, Kienreich K, Verheyen N, Marz W, Pilz S, Zittermann A. Vitamin D Supplementation and Hemoglobin Levels in Hypertensive Patients: A Randomized Controlled Trial. Int J Endocrinol. 2016;2016:6836402. doi: 10.1155/2016/6836402. Epub 2016 Feb 23.
PubMed 27006655Pilz S, Gaksch M, Kienreich K, Grubler M, Verheyen N, Fahrleitner-Pammer A, Treiber G, Drechsler C, O Hartaigh B, Obermayer-Pietsch B, Schwetz V, Aberer F, Mader J, Scharnagl H, Meinitzer A, Lerchbaum E, Dekker JM, Zittermann A, Marz W, Tomaschitz A. Effects of vitamin D on blood pressure and cardiovascular risk factors: a randomized controlled trial. Hypertension. 2015 Jun;65(6):1195-201. doi: 10.1161/HYPERTENSIONAHA.115.05319. Epub 2015 Mar 23.
PubMed 25801871
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Styrian Vitamin D Hypertension Trial: A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Effects of Vitamin D Supplementation on Systolic Ambulatory Blood Pressure in Vitamin D Deficient Hypertensive Patients
- ClinicalTrials.gov ID
- NCT02136771
- Acronym / sponsor ID
- EudraCT no:2009-018125-70
- Conditions
- Arterial Hypertension, Vitamin D Deficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 13 May 2014 (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.
In this randomized, double-blind, placebo-controlled trial we plan to enrol 200 vitamin D deficient hypertensive patients. Our main objective is to evaluate whether vitamin D3 supplementation with 2,800 IU daily for 8 weeks has an effect on 24-hour systolic ambulatory blood pressure (ABP) compared to placebo. In addition, we also aim to evaluate whether vitamin D3 supplementation alters 24-hour diastolic ABP, pulse wave velocity, N-terminal-pro-brain natriuretic peptide (NT-pro-BNP), corrected QT interval (Bazett formula), renin, aldosterone, 24-hour urinary albumin excretion, HOMA-IR (HOmeostatic Model Assessment: Insulin Resistance), triglycerides and HDL-cholesterol.
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 |
|---|---|---|
| Vitamin D3 | Active comparator | Dietary Supplement: Vitamin D3The treatment group receives 2,800 IU vitamin D3 per day as oily drops (Oleovit D3; producer: Fresenius Kabi Austria, A-8055 Graz) for 8 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboOily drops as placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 25-hydroxyvitamin D levels below 30 ng/ml (75 nmol/L)
- Arterial hypertension defined according to recent guidelines as an average office blood pressure on at least two occasions of systolic ≥ 140 and/or diastolic ≥ 90 mmHg or a mean 24-hour ABP of systolic ≥ 125 and/or diastolic ≥ 80, or a home blood pressure of systolic ≥ 130 and/or diastolic ≥ 85 or ongoing antihypertensive treatment which was initiated due to arterial hypertension
- Age of ≥ 18 years
- Written informed consent.
Key exclusion criteria (12 listed)
- Hypercalcemia defined a serum calcium >2.65 mmol/L
- Pregnancy or lactating women
- Drug intake as part of another clinical study
- Acute coronary syndrome or cerebrovascular events in the previous 2 weeks
- Glomerular filtration rate (GFR) according to the MDRD formula < 15 ml/min/1.73m²
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 |
|---|---|---|
| Vitamin D3The treatment group receives 2,800 IU vitamin D3 per day as oily drops (Oleovit D3, producer: Fresenius Kabi Austria, A-8055 Graz) for 8 weeks | Dietary supplement | Vitamin D3 |
| Placebo | Dietary supplement | Placebo |
Primary outcome
24-hour systolic ambulatory blood pressure
Time frame: 8 weeks
10 secondary outcomes
24-hour diastolic ambulatory blood pressure
Time frame: 8 weeks
N-terminal-pro-brain natriuretic peptide (NT-pro-BNP)
Time frame: 8 weeks
corrected QT interval (Bazett formula)
Time frame: 8 weeks
Renin
Time frame: 8 weeks
Aldosterone
Time frame: 8 weeks
24-hour urinary albumin excretion
Time frame: 8 weeks
HOMA-IR
Time frame: 8 weeks
Triglycerides
Time frame: 8 weeks
HDL-cholesterol
Time frame: 8 weeks
Pulse wave velocity
Time frame: 8 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 25 Nov 2014.
- Derived from this study: PubMed 34629245Grubler MR, Zittermann A, Verheyen ND, Trummer C, Theiler-Schwetz V, Keppel MH, Malle O, Richtig G, Gangler S, Bischoff-Ferrari H, Scharnagl H, Meinitzer A, Marz W, Tomaschitz A, Pilz S. Randomized trial of vitamin D versus placebo supplementation on markers of systemic inflammation in hypertensive patients. Nutr Metab Cardiovasc Dis. 2021 Oct 28;31(11):3202-3209. doi: 10.1016/j.numecd.2021.07.028. Epub 2021 Aug 18.
- Derived from this study: PubMed 28027911Grubler MR, Gaksch M, Kienreich K, Verheyen ND, Schmid J, Mullner C, Richtig G, Scharnagl H, Trummer C, Schwetz V, Meinitzer A, Pieske B, Marz W, Tomaschitz A, Pilz S. Effects of Vitamin D3 on asymmetric- and symmetric dimethylarginine in arterial hypertension. J Steroid Biochem Mol Biol. 2018 Jan;175:157-163. doi: 10.1016/j.jsbmb.2016.12.014. Epub 2016 Dec 24.
- Derived from this study: PubMed 27098193Grubler MR, Gaksch M, Kienreich K, Verheyen N, Schmid J, O Hartaigh BW, Richtig G, Scharnagl H, Meinitzer A, Pieske B, Fahrleitner-Pammer A, Marz W, Tomaschitz A, Pilz S. Effects of Vitamin D Supplementation on Plasma Aldosterone and Renin-A Randomized Placebo-Controlled Trial. J Clin Hypertens (Greenwich). 2016 Jul;18(7):608-13. doi: 10.1111/jch.12825. Epub 2016 Apr 21.
- Derived from this study: PubMed 27006655Ernst JB, Tomaschitz A, Grubler MR, Gaksch M, Kienreich K, Verheyen N, Marz W, Pilz S, Zittermann A. Vitamin D Supplementation and Hemoglobin Levels in Hypertensive Patients: A Randomized Controlled Trial. Int J Endocrinol. 2016;2016:6836402. doi: 10.1155/2016/6836402. Epub 2016 Feb 23.
- Derived from this study: PubMed 25801871Pilz S, Gaksch M, Kienreich K, Grubler M, Verheyen N, Fahrleitner-Pammer A, Treiber G, Drechsler C, O Hartaigh B, Obermayer-Pietsch B, Schwetz V, Aberer F, Mader J, Scharnagl H, Meinitzer A, Lerchbaum E, Dekker JM, Zittermann A, Marz W, Tomaschitz A. Effects of vitamin D on blood pressure and cardiovascular risk factors: a randomized controlled trial. Hypertension. 2015 Jun;65(6):1195-201. doi: 10.1161/HYPERTENSIONAHA.115.05319. Epub 2015 Mar 23.
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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.
Stefan Pilz, MD, PhD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D3 in people with Arterial Hypertension and Vitamin D Deficiency, run by Medical University of Graz at 1 site in Austria.
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 4 inclusion and 12 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 25 Nov 2014. 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 Austria. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 ambulatory blood pressure (time frame: 8 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 NCT02136771, which also lists 5 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 25 Nov 2014.