Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014