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Vitamin D Deficiency: Bone Loss and Vascular Dysfunction

Primary Purpose

Postmenopausal Women

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
10 vit. D deficient subjects take vit. D for 3 months.
Sponsored by
University of Kansas
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postmenopausal Women focused on measuring vitamin D deficiency postmenopausal women

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Kansas Medical Center

Outcomes

Primary Outcome Measures

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 Outcome Measures

Vitamin D at the end of 3 months of supplementation.

Full Information

First Posted
October 6, 2005
Last Updated
September 18, 2007
Sponsor
University of Kansas
Collaborators
National Osteoporosis Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00235586
Brief Title
Vitamin D Deficiency: Bone Loss and Vascular Dysfunction
Official Title
Vitamin D Deficiency: Bone Loss and Vascular Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Kansas
Collaborators
National Osteoporosis Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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".

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Women
Keywords
vitamin D deficiency postmenopausal women

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
10 vit. D deficient subjects take vit. D for 3 months.
Primary Outcome Measure Information:
Title
to determine if differences exist in vascular compliance and carotid artery intima media thickness between individuals with normal and low vitamin D levels
Title
to evaluate correlation of markers of vascular disease and boen disease between individuals with normal and low vitamin D
Title
to quantify the effect of Vitamin D replacement on vascular compliance and markers of bone loss and vascular disease.
Secondary Outcome Measure Information:
Title
Vitamin D at the end of 3 months of supplementation.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leland Graves, III, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

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Vitamin D Deficiency: Bone Loss and Vascular Dysfunction

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