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
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2009-08-31
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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cholecalciferol
3000 IU cholecalciferol per day for 16 weeks
cholecalciferol
Capsule cholecalciferol 1000 IU, 3 capsules per day for 16 weeks
placebo
placebo
Empty capsules, 3 capsules per day for 16 weeks
Interventions
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cholecalciferol
Capsule cholecalciferol 1000 IU, 3 capsules per day for 16 weeks
placebo
Empty capsules, 3 capsules per day for 16 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* p 25OH vitaminD\<50nmol/l
* signed informed consent
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Zealand University Hospital
OTHER
Responsible Party
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Principal Investigators
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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
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Roskilde Hospital
Roskilde, Roskilde, Denmark
Countries
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References
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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.
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.
Other Identifiers
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7. juli 2009, version 1
Identifier Type: -
Identifier Source: org_study_id
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