Hypertensive DiseaseNCT01501916
Effect of Vitamin D3 on Cardiovascular Risk Factors
A study testing Vitamin D3 in people with Hypertensive Disease and Deficiency of Vitamin D3, run by Martin-Luther-Universität Halle-Wittenberg.
Trial summary
The aim of this study is to investigate whether a supplementation of Vitamin D3 can be used to reduce atherosclerotic risk factors. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertensive Disease, Deficiency of Vitamin D3
- What is being tested?
- Vitamin D3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to Dec 2013
- 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
- human volunteers with mild hypertension
Who cannot join
- use of antihypertensive medication
- use of vitamin d or calcium supplements
- known renal, inflammatory or malignant diseases
- hypercalcemia or hypercalciuria
- participation in other clinical studies
- use of tanning booths during the study
About this study
Official title: Effect of Vitamin D3 on Cardiovascular Risk Factors: a Randomized Trial in Human
The aim of this study is to investigate whether a supplementation of Vitamin D3 can be used to reduce atherosclerotic risk factors.
Read the detailed description
It is the objective of this study to investigate whether a supplementation with Vitamin D3 can be used to reduce atherosclerotic risk factors such as hypertension, inflammation and hyperlipidemia. The research question is whether Vitamin D3 can lower blood pressure in mildly hypertensive subjects who are naive to antihypertensive medication, whether Vitamin D reduces the level of systemic inflammation and whether Vitamin D3 has an effect on blood lipids.
major outcomes:
- decrease of systolic blood pressure in the treatment group in comparison with the placebo group
- Conditions
- Hypertensive Disease, Deficiency of Vitamin D3
- Being tested
- Vitamin D3, Placebo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
Also called cholecalciferol
daily dosage of 50 µg Vitamin D3 for 8 weeks
PlaceboDietary supplement
daily intake of placebo
| Study group | Role | What they receive |
|---|---|---|
| vitamin d | Experimental | Not described Receives: Dietary Supplement: Vitamin D3 |
| 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.
blood pressure
major outcome variable is the decrease oy systolic blood pressure in the treatment group in comparison with the placebo group.
Measured: after 8 weeks of supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2011 (estimated)
- Study startDec 2012
- Primary completionApr 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertensive DiseaseStudies 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Principal investigator, Ulf Schlegelmilch, Martin-Luther-Universität Halle-Wittenberg
- Investigators
- Jutta Dierkes, Prof. Dr., Study director, Institut für Agrar- und Ernährungswissenschaften
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501916
- Sponsor's protocol ID
- 0315668A
- Status last verified
- Oct 2018
- First submitted
- 4 Nov 2011
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D3 on Cardiovascular Risk Factors: a Randomized Trial in Human
- ClinicalTrials.gov ID
- NCT01501916
- Acronym / sponsor ID
- 0315668A
- Conditions
- Hypertensive Disease, Deficiency of Vitamin D3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Martin-Luther-Universität Halle-WittenbergUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Dec 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 30 Dec 2011 (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 aim of this study is to investigate whether a supplementation of Vitamin D3 can be used to reduce atherosclerotic risk factors.
Detailed description
It is the objective of this study to investigate whether a supplementation with Vitamin D3 can be used to reduce atherosclerotic risk factors such as hypertension, inflammation and hyperlipidemia. The research question is whether Vitamin D3 can lower blood pressure in mildly hypertensive subjects who are naive to antihypertensive medication, whether Vitamin D reduces the level of systemic inflammation and whether Vitamin D3 has an effect on blood lipids.
major outcomes:
- decrease of systolic blood pressure in the treatment group in comparison with the placebo group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin d | Experimental | Dietary Supplement: Vitamin D3 |
| 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 (1 listed)
- human volunteers with mild hypertension
Key exclusion criteria (6 listed)
- use of antihypertensive medication
- use of vitamin d or calcium supplements
- known renal, inflammatory or malignant diseases
- hypercalcemia or hypercalciuria
- participation in other clinical studies
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 D3Also: cholecalciferoldaily dosage of 50 µg Vitamin D3 for 8 weeks | Dietary supplement | vitamin d |
| Placebodaily intake of placebo | Dietary supplement | Placebo |
Primary outcome
blood pressure
Time frame: after 8 weeks of supplementation
major outcome variable is the decrease oy systolic blood pressure in the treatment group in comparison with the placebo group.
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 11 Oct 2018.
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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.
Jutta Dierkes, Prof. Dr. study director
Institut für Agrar- und Ernährungswissenschaften
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 in people with Hypertensive Disease and Deficiency of Vitamin D3, run by Martin-Luther-Universität Halle-Wittenberg.
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 1 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 11 Oct 2018. 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. 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?
blood pressure (time frame: after 8 weeks of supplementation). 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 11 Oct 2018.