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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT00718276
First received: July 17, 2008
Last updated: December 22, 2011
Last verified: December 2011
  Purpose

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 Intervention Phase
Healthy
Drug: 25(OH)D
Dietary Supplement: vitamin D3
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharmacokinetic Study in Healthy Postmenopausal Women to Compare Supplementation of Vitamin D3 to 25(OH)D

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • serum 25(OH)D levels [ Time Frame: repeated assessments over 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • muscle strength, blood pressure, blood glucose, bone markers [ Time Frame: repeated assessments over 4 months ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: March 2008
Study Completion Date: September 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT00718276     History of Changes
Other Study ID Numbers: 2007-09-13-HyD
Study First Received: July 17, 2008
Last Updated: December 22, 2011
Health Authority: Switzerland: Ethikkommission
Switzerland: Swissmedic

Keywords provided by University of Zurich:
Healthy postmenopausal women

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

ClinicalTrials.gov processed this record on April 17, 2014