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Pharmacokinetic Study: Effect of 25(OH)D and Vitamin D3 on Serum 25(OH)D

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ClinicalTrials.gov Identifier: NCT00718276
Recruitment Status : Completed
First Posted : July 18, 2008
Last Update Posted : December 23, 2011
Sponsor:
Information provided by (Responsible Party):
University of Zurich

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 postmenopausal women.

  • Trial with medicinal product

Condition or disease Intervention/treatment Phase
Healthy Drug: 25(OH)D Dietary Supplement: vitamin D3 Phase 1

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 doses over a 4 month pharmacokinetic trial. The dosing arms are daily, weekly, and bolus


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharmacokinetic Study in Healthy Postmenopausal Women to Compare Supplementation of Vitamin D3 to 25(OH)D
Study Start Date : March 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
25(OH)D
Drug: 25(OH)D
daily (20ug), weekly (140 ug), Bolus (140 ug)
Other Name: HyD
Active Comparator: 2
vitamin D3
Dietary Supplement: vitamin D3
daily (800 IU), weekly (5600 IU), Bolus (5600 Iu)
Other Name: Cholecalciferol



Primary Outcome Measures :
  1. serum 25(OH)D levels [ Time Frame: repeated assessments over 4 months ]

Secondary Outcome Measures :
  1. muscle strength, blood pressure, blood glucose, bone markers [ Time Frame: repeated assessments over 4 months ]


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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT00718276


Locations
Switzerland
University Hospital Zurich, Centre on Aging and Mobility
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Heike Bischoff Ferrari, MD, MPH University Hospital Zurich, Centre on Aging and Mobility

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT00718276     History of Changes
Other Study ID Numbers: 2007-09-13-HyD
First Posted: July 18, 2008    Key Record Dates
Last Update Posted: December 23, 2011
Last Verified: December 2011

Keywords provided by University of Zurich:
Healthy postmenopausal women

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