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Completed

NCT Number: NCT00952562

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

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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Roskilde Hospital

Roskilde, 4000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholecalciferol

Dietary Supplement

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

Other names: D3-Vitamin

Placebo

Dietary Supplement

Empty capsules, 3 capsules per day for 16 weeks

Primary outcomes

  1. urinary calcium excretion

    Time frame: before and after 16 weeks of intervention

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Registry information

Official study 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.

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Aug 6, 2009
Registry last updated
Aug 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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