NCT01501916

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 30, 2011

Completed
11 months until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

4 months

First QC Date

November 4, 2011

Last Update Submit

October 10, 2018

Conditions

Hypertensive DiseaseDeficiency of Vitamin D3

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

vitamin d

EXPERIMENTAL
Dietary Supplement: Vitamin D3

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

Vitamin D3DIETARY_SUPPLEMENT

daily dosage of 50 µg Vitamin D3 for 8 weeks

Also known as: cholecalciferol
vitamin d
PlaceboDIETARY_SUPPLEMENT

daily intake of placebo

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • human volunteers with mild hypertension

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Jutta Dierkes, Prof. Dr.

    Institut für Agrar- und Ernährungswissenschaften

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 4, 2011

First Posted

December 30, 2011

Study Start

December 1, 2012

Primary Completion

April 1, 2013

Study Completion

December 1, 2013

Last Updated

October 11, 2018

Record last verified: 2018-10