Pharmacokinetic Study: Effect of 25(OH)D and Vitamin D3 on Serum 25(OH)D
NCT ID: NCT00718276
Last Updated: 2011-12-23
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
PHASE1
35 participants
INTERVENTIONAL
2008-03-31
2008-09-30
Brief Summary
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* Trial with medicinal product
Detailed Description
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to compare 25(OH)D and vitamin D3 in equimolar doses over a 4 month pharmacokinetic trial. The dosing arms are daily, weekly, and bolus
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
25(OH)D
25(OH)D
daily (20ug), weekly (140 ug), Bolus (140 ug)
2
vitamin D3
vitamin D3
daily (800 IU), weekly (5600 IU), Bolus (5600 Iu)
Interventions
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25(OH)D
daily (20ug), weekly (140 ug), Bolus (140 ug)
vitamin D3
daily (800 IU), weekly (5600 IU), Bolus (5600 Iu)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 50 to 75 years
* Body mass index 18-29 kg/m2
* 25-hydroxyvitamin D levels 20 to 60 nmol/l
* Caucasian
* Generally healthy
Exclusion Criteria
* Use if dietary supplements (\> 400 IU vitamin D per day, \> 600 mg of calcium per day)
* Hypertension
* Diseases that carry the risk of hypercalcemia
* Use of any drug that interferes with bone metabolism in the last 12 months (bisphosphonates estrogen receptor modulators, PTH, calcitonin)
* Oral HRT in the last 6 months
* Extreme diets
* Fracture or fall in the last 3 months
* Current smoking or alcohol abuse
* Planning on a sunny vacation in the course of the trial
* Kidney stone history
* Creatinine clearance \< 30 ml/min
* Co-medications: anticoagulants, PTH, corticosteroids, thiazide diuretics, digoxin, anticonvulsants, malabsorption,z C
50 Years
75 Years
FEMALE
Yes
Sponsors
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University of Zurich
OTHER
Responsible Party
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Principal Investigators
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Heike Bischoff Ferrari, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University Hospital Zurich, Centre on Aging and Mobility
Locations
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University Hospital Zurich, Centre on Aging and Mobility
Zurich, Canton of Zurich, Switzerland
Countries
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Other Identifiers
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2007-09-13-HyD
Identifier Type: -
Identifier Source: org_study_id