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

Healthy Clinical Trial

Official title:

Pharmacokinetic Study in Healthy Postmenopausal Women to Compare Supplementation of Vitamin D3 to 25(OH)D

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00718276
• Other study ID #: 2007-09-13-HyD
• Status: Completed
• Phase: Phase 1
• First received: July 17, 2008
• Last updated: December 22, 2011
• Start date: March 2008
• Est. completion date: September 2008

Study information

• Verified date: December 2011
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: EthikkommissionSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• 25(OH)D
daily (20ug), weekly (140 ug), Bolus (140 ug)

Dietary Supplement:
• vitamin D3
daily (800 IU), weekly (5600 IU), Bolus (5600 Iu)

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Centre on Aging and Mobility	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum 25(OH)D levels		repeated assessments over 4 months	No
Secondary	muscle strength, blood pressure, blood glucose, bone markers		repeated assessments over 4 months	No