Vitamin D Deficiency: Bone Loss and Vascular Dysfunction | NCT00235586

Studies
Vitamin D Deficiency: Bone Loss and Vascular Dysfunction

NCT00235586

Sponsor

University of Kansas

Status

Completed

Last Update Posted

Sep 20, 2007Estimated

Enrollment

Phase

Not Applicable

Conditions

Postmenopausal Women

Interventions

10 vit. D deficient subjects take vit. D for 3 months.

Countries

United States

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

Sep 2007

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

Apr 2004

Primary Completion Date

Not provided

Completion Date

Sep 2007Actual

First Submitted Date

Oct 6, 2005

First Submission Date that Met QC Criteria

Oct 7, 2005

First Posted Date

Oct 10, 2005Estimated

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

Sep 18, 2007

Last Update Posted Date

Sep 20, 2007Estimated

Name	Class
National Osteoporosis Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

To learn if there is a connection between low vitamin D level and hardening of the arteries.

Detailed Description

Osteoporosis and vascular disease are two of the most common disorders affecting postmenopausal women. A potential association, beyond aging, has long been speculated. Our previous study revealed evidence of loss of vascular compliance in postmenopausal women with lower bone density, suggesting women with lower bone density had "stiffer" blood vessels. This proposal further investigates that association and a potential role of vitamin D deficiency as a possible common link between both bone loss and "hardening of the arteries".

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
10 vit. D deficient subjects take vit. D for 3 months.	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
to determine if differences exist in vascular compliance and carotid artery intima media thickness between individuals with normal and low vitamin D levels
to evaluate correlation of markers of vascular disease and boen disease between individuals with normal and low vitamin D
to quantify the effect of Vitamin D replacement on vascular compliance and markers of bone loss and vascular disease.

Secondary Outcomes

Measure	Description	Time Frame
Vitamin D at the end of 3 months of supplementation.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Females ages 50-70 with ability to give informed consent
One year past last menstrual period
20 women with Vitamin D levels < 15 mg/ml
20 women with Vitamin D levels > 30 mg/ml

Exclusion Criteria:

women receiving hormone replacement therapy
women receiving medication known to effect vascular compliance, including anti-hypertension medications
subjects receiving therapy for osteoporosis
hyperthyroidism
untreated hypothyroidism
history of metabolic bone disease
current or previous use of medications known to accelerate bone loss
chronic liver disease
chronic renal disease
diabetes mellitus
obesity, BMI > 24

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

90 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
Leland Graves, III, MD	University of Kansas Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Kansas Medical Center		Kansas City	Kansas	66160	United States