Effect of Vitamin D3 on Cardiovascular Risk Factors | NCT01501916

Studies
Effect of Vitamin D3 on Cardiovascular Risk Factors

NCT01501916

Sponsor

Martin-Luther-Universität Halle-Wittenberg

Status

Completed

Last Update Posted

Oct 11, 2018Actual

Enrollment

250Actual

Phase

Not Applicable

Conditions

Hypertensive Disease
Deficiency of Vitamin D3

Interventions

Vitamin D3
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Apr 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Nov 4, 2011

First Submission Date that Met QC Criteria

Dec 27, 2011

First Posted Date

Dec 30, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2018

Last Update Posted Date

Oct 11, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ulf Schlegelmilch, Principal Investigator, Martin-Luther-Universität Halle-WittenbergPrincipal Investigator

Lead Sponsor

Martin-Luther-Universität Halle-WittenbergOTHER

Collaborators

Name	Class
German Federal Ministry of Education and Research	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

250Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
vitamin d	Experimental		Dietary Supplement: Vitamin D3
Placebo	Placebo Comparator		Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitamin D3	Dietary Supplement	daily dosage of 50 µg Vitamin D3 for 8 weeks	vitamin d

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
blood pressure	major outcome variable is the decrease oy systolic blood pressure in the treatment group in comparison with the placebo group.	after 8 weeks of supplementation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jutta Dierkes, Prof. Dr.	Institut für Agrar- und Ernährungswissenschaften	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002762	Cholecalciferol

Ancestor Terms

ID	Term
D002782	Cholestenes
D002776	Cholestanes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided