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

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ClinicalTrials.gov Identifier: NCT00952562
Recruitment Status : Completed
First Posted : August 6, 2009
Last Update Posted : August 24, 2011
Sponsor:
Information provided by (Responsible Party):
Zealand University Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Dietary Supplement: cholecalciferol Dietary Supplement: placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : August 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals Vitamin D

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. urinary calcium excretion [ Time Frame: before and after 16 weeks of intervention ]

Secondary Outcome Measures :
  1. 25 hydroxyvitamin D [ Time Frame: before and after 16 weeks og treatment ]
  2. 1,25 dihydroxyvitamin D [ Time Frame: before and after 16 weeks of treatment ]
  3. urinary creatinin [ Time Frame: before and after 16 weeks of treatment ]
  4. urinary protein [ Time Frame: before and after 16 weeks of treatment ]
  5. urinary phosphorous [ Time Frame: before and after 16 weeks of treatment ]
  6. p-FGF23 [ Time Frame: before and after 16 weeks of treatment ]
  7. blood pressure [ Time Frame: before and after 16 weeks of treatment ]
  8. pulse wave velocity [ Time Frame: before and after 16 weeks of treatment ]
  9. augmentation index [ Time Frame: before and after 16 weeks of treatment ]
  10. central blood pressure [ Time Frame: before and after 16 weeks of treatment ]
  11. p-phosphate [ Time Frame: before and after 16 weeks of treatment ]
  12. ionised p-calcium [ Time Frame: before and after 16 weeks of treatment ]
  13. p-iPTH [ Time Frame: before and after 16 weeks of treatment ]
  14. alkalic phosphatase [ Time Frame: before and after 16 weeks of treatment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00952562


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Zealand University Hospital
ClinicalTrials.gov Identifier: NCT00952562     History of Changes
Other Study ID Numbers: 7. juli 2009, version 1
First Posted: August 6, 2009    Key Record Dates
Last Update Posted: August 24, 2011
Last Verified: August 2011

Keywords provided by Zealand University Hospital:
vitamin d
calcium
blood pressure

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