Pharmacokinetic Study: Effect of 25(OH)D and Vitamin D3 o... | NCT00718276

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

NCT00718276

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Dec 23, 2011Estimated

Enrollment

35Actual

Phase

Phase 1

Conditions

Healthy

Interventions

25(OH)D
vitamin D3

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Aug 2008Actual

Completion Date

Sep 2008Actual

First Submitted Date

Jul 17, 2008

First Submission Date that Met QC Criteria

Jul 17, 2008

First Posted Date

Jul 18, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 22, 2011

Last Update Posted Date

Dec 23, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	25(OH)D	Drug: 25(OH)D
2	Active Comparator	vitamin D3	Dietary Supplement: vitamin D3

Interventions

Name	Type	Description	Arm Group Labels	Other Names
25(OH)D	Drug	daily (20ug), weekly (140 ug), Bolus (140 ug)	1	HyD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
serum 25(OH)D levels		repeated assessments over 4 months

Secondary Outcomes

Measure	Description	Time Frame
muscle strength, blood pressure, blood glucose, bone markers		repeated assessments over 4 months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Heike Bischoff Ferrari, MD, MPH	University Hospital Zurich, Centre on Aging and Mobility	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Zurich, Centre on Aging and Mobility		Zurich	Canton of Zurich	8091	Switzerland

Intervention Browse Module

MeSH Terms

ID	Term
D002762	Cholecalciferol

Ancestor Terms

ID	Term
D002782	Cholestenes
D002776	Cholestanes
D013256	Steroids
D000072473	Fused-Ring Compounds

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