Effect of Vitamin D3 on Cardiovascular Risk Factors

NCT ID: NCT01501916

Last Updated: 2018-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-12-31

Brief Summary

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The aim of this study is to investigate whether a supplementation of Vitamin D3 can be used to reduce atherosclerotic risk factors.

Detailed Description

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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

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Hypertensive Disease Deficiency of Vitamin D3

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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vitamin d

Group Type EXPERIMENTAL

Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

daily dosage of 50 µg Vitamin D3 for 8 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

daily intake of placebo

Interventions

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Vitamin D3

daily dosage of 50 µg Vitamin D3 for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

daily intake of placebo

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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cholecalciferol

Eligibility Criteria

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Inclusion Criteria

* human volunteers with mild hypertension

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role collaborator

Martin-Luther-Universität Halle-Wittenberg

OTHER

Sponsor Role lead

Responsible Party

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Ulf Schlegelmilch

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jutta Dierkes, Prof. Dr.

Role: STUDY_DIRECTOR

Institut für Agrar- und Ernährungswissenschaften

Other Identifiers

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0315668A

Identifier Type: -

Identifier Source: org_study_id

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