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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
History of Changes
  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:

U.S. FDA Resources

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
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

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:
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
 Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 19, 2013