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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: 25(OH)D; Dietary Supplement: vitamin D3

• Registration Number: NCT00718276
• Lead Sponsor: 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

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 Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-07-17
• Study First Submitted QC: 2008-07-17
• Study First Posted: 2008-07-18
• Primary Completion: 2008-08
• Study Completion: 2008-09
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-22
• Last Update Posted: 2011-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	25(OH)D	25(OH)D
2	vitamin D3	vitamin D3

Primary Outcome Measures

Name	Time	Method
serum 25(OH)D levels	repeated assessments over 4 months

Secondary Outcome Measures

Name	Time	Method
muscle strength, blood pressure, blood glucose, bone markers	repeated assessments over 4 months

Trial Locations

Locations (1)

University Hospital Zurich, Centre on Aging and Mobility; 🇨🇭 Zurich, ZH, Switzerland