The Influence of Vitamin D on Mineral Metabolism, Blood Pressure and Pulse Wave Analysis in Healthy Individuals

NCT ID: NCT00952562

Last Updated: 2011-08-24

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A randomized placebo controlled trial evaluating the effect of the recently recommended high doses of cholecalciferol (3000 IU/day) on mineral metabolism, blood pressure and pulse wave analysis in healthy individuals.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

cholecalciferol

3000 IU cholecalciferol per day for 16 weeks

Group Type ACTIVE_COMPARATOR

cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

Capsule cholecalciferol 1000 IU, 3 capsules per day for 16 weeks

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

Empty capsules, 3 capsules per day for 16 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

cholecalciferol

Capsule cholecalciferol 1000 IU, 3 capsules per day for 16 weeks

Intervention Type DIETARY_SUPPLEMENT

placebo

Empty capsules, 3 capsules per day for 16 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

D3-Vitamin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* \> 18 years old
* p 25OH vitaminD\<50nmol/l
* signed informed consent

Exclusion Criteria

* receiving antihypertensive or antidiabetic treatment
* sarcoidoses
* history of kidney stones
* receiving 1-alfa-hydroxylated vitamin D treatment
* plasma creatinin \> 120 micromol/l
* ionised calcium \> 1,5 mmol/l
* treatment with calcimimetics
* active malignancy
* intestinal malabsorption
* active pancreatitis
* former hospitalisation due to alcoholic related disease
* using euphoriant drugs
* pregnancy or risk of being pregnant or lactating women
* Known allergy to cholecalciferol capsules
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Zealand University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ditte Hansen, MD

Role: PRINCIPAL_INVESTIGATOR

Zealand University Hospital

Niels Erik Frandsen, MD

Role: PRINCIPAL_INVESTIGATOR

Zealand University Hospital

Knud Rasmussen, DmSci

Role: PRINCIPAL_INVESTIGATOR

Zealand University Hospital

Lisbet Brandi, DmSci

Role: PRINCIPAL_INVESTIGATOR

Zealand University Hospital

Hans Christian Hoeck, DmSci

Role: PRINCIPAL_INVESTIGATOR

Center for clinical and basic research

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Roskilde Hospital

Roskilde, Roskilde, Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

References

Explore related publications, articles, or registry entries linked to this study.

Bressendorff I, Brandi L, Schou M, Nygaard B, Frandsen NE, Rasmussen K, Odum L, Ostergaard OV, Hansen D. The Effect of High Dose Cholecalciferol on Arterial Stiffness and Peripheral and Central Blood Pressure in Healthy Humans: A Randomized Controlled Trial. PLoS One. 2016 Aug 10;11(8):e0160905. doi: 10.1371/journal.pone.0160905. eCollection 2016.

Reference Type DERIVED
PMID: 27509187 (View on PubMed)

Nygaard B, Frandsen NE, Brandi L, Rasmussen K, Oestergaard OV, Oedum L, Hoeck HC, Hansen D. Effects of high doses of cholecalciferol in normal subjects: a randomized double-blinded, placebo-controlled trial. PLoS One. 2014 Aug 28;9(8):e102965. doi: 10.1371/journal.pone.0102965. eCollection 2014.

Reference Type DERIVED
PMID: 25166750 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

7. juli 2009, version 1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Styrian Vitamin D Hypertension Trial
NCT02136771 COMPLETED PHASE4
Effect of Vitamin D Treatment on Fatigue
NCT02022475 COMPLETED PHASE3