10 vit. D deficient subjects take vit. D for 3 months. in Postmenopausal Women - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Postmenopausal Women

Intervention / Treatment

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

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".

Study Type

Interventional

Enrollment

40

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Kansas
  - Kansas City, Kansas, United States, 66160
    - University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Factorial Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Vitamin D at the end of 3 months of supplementation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas

Collaborators

National Osteoporosis Foundation

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

October 6, 2005

First Submitted That Met QC Criteria

October 7, 2005

First Posted (Estimate)

October 10, 2005

Study Record Updates

Last Update Posted (Estimate)

September 20, 2007

Last Update Submitted That Met QC Criteria

September 18, 2007

Last Verified