Vitamin D Deficiency: Bone Loss and Vascular Dysfunction

• Sponsor: University of Kansas (Other)
• Overall Status: Completed
• CT.gov ID: NCT00235586
• Collaborator: National Osteoporosis Foundation (Other)
• Enrollment: 40
• Location: 1
• Duration (Months): 41
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Postmenopausal Women	Procedure: 10 vit. D deficient subjects take vit. D for 3 months.	N/A

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 Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Vitamin D Deficiency: Bone Loss and Vascular Dysfunction
• Study Start Date: Apr 1, 2004
• Actual Study Completion Date: Sep 1, 2007

Outcome Measures

Primary Outcome Measures

1. to determine if differences exist in vascular compliance and carotid artery intima media thickness between individuals with normal and low vitamin D levels []

2. to evaluate correlation of markers of vascular disease and boen disease between individuals with normal and low vitamin D []

3. to quantify the effect of Vitamin D replacement on vascular compliance and markers of bone loss and vascular disease. []

Secondary Outcome Measures

1. Vitamin D at the end of 3 months of supplementation. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 90 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kansas Medical Center	Kansas City	Kansas	United States	66160

Sponsors and Collaborators

• University of Kansas
• National Osteoporosis Foundation

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00235586
• Other Study ID Numbers: 9248
• First Posted: Oct 10, 2005
• Last Update Posted: Sep 20, 2007
• Last Verified: Sep 1, 2007

• Keywords provided by , ,: vitamin D deficiency postmenopausal women
• Additional relevant MeSH terms: Vitamin D Deficiency

Study Results

No Results Posted as of Sep 20, 2007