Pharmacokinetic Study: Effect of 25(OH)D and Vitamin D3 on Serum 25(OH)D - Full Text View

Sponsored by:	University of Zurich
Information provided by:	University of Zurich
ClinicalTrials.gov Identifier:	NCT00718276

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 I

MedlinePlus related topics: Dietary Supplements

Drug Information available for: Cholecalciferol Vitamin D

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Pharmacokinetics Study
Official Title:	Pharmacokinetic Study in Healthy Postmenopausal Women to Compare Supplementation of Vitamin D3 to 25(OH)D

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 ]

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

Arms	Assigned Interventions
1: Active Comparator 25(OH)D	Drug: 25(OH)D daily (20ug), weekly (140 ug), Bolus (140 ug)
2: Active Comparator vitamin D3	Dietary Supplement: vitamin D3 daily (800 IU), weekly (5600 IU), Bolus (5600 Iu)

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 of Zurich
Zurich, Switzerland, 8091

Sponsors and Collaborators

University of Zurich

Investigators

Study Director:

01 Studienregister MasterAdmins

UniversitaetsSpital Zuerich

More Information

No publications provided

Responsible Party:	University of Zurich ( Prof. Heike A: Bischoff-Ferrari, MPH )
Study ID Numbers:	2007-09-13-HyD
Study First Received:	July 17, 2008
Last Updated:	July 17, 2008
ClinicalTrials.gov Identifier:	NCT00718276 History of Changes
Health Authority:	Switzerland: Ethikkommission; Switzerland: Swissmedic

Keywords provided by University of Zurich:

Healthy postmenopausal women

Study placed in the following topic categories:

Cholecalciferol
Vitamin D
Vitamins
Bone Density Conservation Agents

Trace Elements
Micronutrients
Healthy

Additional relevant MeSH terms:

Cholecalciferol
Vitamin D
Growth Substances
Vitamins

Physiological Effects of Drugs
Bone Density Conservation Agents
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009