Vitamin D Deficiency: Bone Loss and Vascular Dysfunction

Postmenopausal Women Clinical Trial

Official title:

Vitamin D Deficiency: Bone Loss and Vascular Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00235586
• Other study ID #: 9248
• Status: Completed
• Phase: N/A
• First received: October 6, 2005
• Last updated: September 18, 2007
• Start date: April 2004
• Est. completion date: September 2007

Study information

• Verified date: September 2007
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 90 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postmenopausal Women
• Vitamin D Deficiency

Intervention

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

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	National Osteoporosis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to determine if differences exist in vascular compliance and carotid artery intima media thickness between individuals with normal and low vitamin D levels
Primary	to evaluate correlation of markers of vascular disease and boen disease between individuals with normal and low vitamin D
Primary	to quantify the effect of Vitamin D replacement on vascular compliance and markers of bone loss and vascular disease.
Secondary	Vitamin D at the end of 3 months of supplementation.