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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roskilde County Hospital
ClinicalTrials.gov Identifier:
NCT00952562
First received: August 3, 2009
Last updated: August 23, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Healthy
Dietary Supplement: cholecalciferol
Dietary Supplement: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Influence of Vitamin D on Mineral Metabolism, Blood Pressure and Pulse Wave Analysis in Healthy Individuals. A Randomised Double Blinded Placebo Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Roskilde County Hospital:

Primary Outcome Measures:
  • urinary calcium excretion [ Time Frame: before and after 16 weeks of intervention ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 25 hydroxyvitamin D [ Time Frame: before and after 16 weeks og treatment ] [ Designated as safety issue: No ]
  • 1,25 dihydroxyvitamin D [ Time Frame: before and after 16 weeks of treatment ] [ Designated as safety issue: No ]
  • urinary creatinin [ Time Frame: before and after 16 weeks of treatment ] [ Designated as safety issue: No ]
  • urinary protein [ Time Frame: before and after 16 weeks of treatment ] [ Designated as safety issue: No ]
  • urinary phosphorous [ Time Frame: before and after 16 weeks of treatment ] [ Designated as safety issue: Yes ]
  • p-FGF23 [ Time Frame: before and after 16 weeks of treatment ] [ Designated as safety issue: No ]
  • blood pressure [ Time Frame: before and after 16 weeks of treatment ] [ Designated as safety issue: No ]
  • pulse wave velocity [ Time Frame: before and after 16 weeks of treatment ] [ Designated as safety issue: No ]
  • augmentation index [ Time Frame: before and after 16 weeks of treatment ] [ Designated as safety issue: No ]
  • central blood pressure [ Time Frame: before and after 16 weeks of treatment ] [ Designated as safety issue: No ]
  • p-phosphate [ Time Frame: before and after 16 weeks of treatment ] [ Designated as safety issue: Yes ]
  • ionised p-calcium [ Time Frame: before and after 16 weeks of treatment ] [ Designated as safety issue: Yes ]
  • p-iPTH [ Time Frame: before and after 16 weeks of treatment ] [ Designated as safety issue: Yes ]
  • alkalic phosphatase [ Time Frame: before and after 16 weeks of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: August 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: cholecalciferol
3000 IU cholecalciferol per day for 16 weeks
Dietary Supplement: cholecalciferol
Capsule cholecalciferol 1000 IU, 3 capsules per day for 16 weeks
Other Name: D3-Vitamin
Placebo Comparator: placebo Dietary Supplement: placebo
Empty capsules, 3 capsules per day for 16 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00952562

Locations
Denmark
Roskilde Hospital
Roskilde, Denmark, 4000
Sponsors and Collaborators
Roskilde County Hospital
Investigators
Principal Investigator: Ditte Hansen, MD Roskilde Hospital
Principal Investigator: Niels Erik Frandsen, MD Roskilde Hospital
Principal Investigator: Knud Rasmussen, DmSci Roskilde Hospital
Principal Investigator: Lisbet Brandi, DmSci Roskilde Hospital
Principal Investigator: Hans Christian Hoeck, DmSci Center for clinical and basic research
  More Information

No publications provided by Roskilde County Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Roskilde County Hospital
ClinicalTrials.gov Identifier: NCT00952562     History of Changes
Other Study ID Numbers: 7. juli 2009, version 1
Study First Received: August 3, 2009
Last Updated: August 23, 2011
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Roskilde County Hospital:
vitamin d
calcium
blood pressure

Additional relevant MeSH terms:
Vitamin D
Vitamins
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on October 20, 2014