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Vitamin D Deficiency: Bone Loss and Vascular Dysfunction

NCT ID: NCT00235586

Last Updated: 2007-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2007-09-30

Brief Summary

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

Detailed Description

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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".

Conditions

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Postmenopausal Women

Keywords

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vitamin D deficiency postmenopausal women

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Osteoporosis Foundation

OTHER

Sponsor Role collaborator

University of Kansas

OTHER

Sponsor Role lead

Principal Investigators

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Leland Graves, III, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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9248

Identifier Type: -

Identifier Source: org_study_id