Vitamin D Deficiency: Bone Loss and Vascular Dysfunction

Study Overview
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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.

Official Title
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Vitamin D Deficiency: Bone Loss and Vascular Dysfunction

Conditions
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Postmenopausal Women

Intervention / Treatment
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* Procedure: 10 vit. D deficient subjects take vit. D for 3 months.


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: 10 vit. D deficient subjects take vit. D for 3 months.|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D at the end of 3 months of supplementation. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin D deficiency postmenopausal women