Status:
COMPLETED
Pharmacokinetic Study: Effect of 25(OH)D and Vitamin D3 on Serum 25(OH)D
Lead Sponsor:
University of Zurich
Conditions:
Healthy
Eligibility:
FEMALE
50-75 years
Phase:
PHASE1
Brief Summary
We compare the effect of HyD (25-hydroxyvitamin D) and vitamin D3 in their effect on 25-hydroxyvitamin D plasma levels over a course of 4 month. This is a pharmacokinetic study including 35 postmenopa...
Detailed Description
We include postmenopausal women age 50 to 75, race/ethnicity: Caucasian, serum 25(OH)D at baseline between 20 to 60 nmol/l, body mass index: \< 30 kg/m2 to compare 25(OH)D and vitamin D3 in equimolar...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Postmenopausal women
- 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:
- Serum calcium \> 2.6 nmol/L
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00718276
Start Date
March 1 2008
End Date
September 1 2008
Last Update
December 23 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital Zurich, Centre on Aging and Mobility
Zurich, Canton of Zurich, Switzerland, 8091