Vitamin D Deficiency: Bone Loss and Vascular Dysfunction

Not Applicable

Completed

• Conditions: Postmenopausal Women

• Registration Number: NCT00235586
• Lead Sponsor: University of Kansas

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".

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2005-10-06
• Study First Submitted QC: 2005-10-07
• Study First Posted: 2005-10-10
• Status Verified: 2007-09
• Study Completion: 2007-09
• Last Update Submitted: 2007-09-18
• Last Update Posted: 2007-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Vitamin D at the end of 3 months of supplementation.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States