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Vitamin D Deficiency: Bone Loss and Vascular Dysfunction

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ClinicalTrials.gov Identifier: NCT00235586
Recruitment Status : Completed
First Posted : October 10, 2005
Last Update Posted : September 20, 2007
Sponsor:
Collaborator:
National Osteoporosis Foundation
Information provided by:
University of Kansas Medical Center

Study Description
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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. Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
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 : April 2004
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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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
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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00235586


Locations
United States, Kansas
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
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00235586     History of Changes
Other Study ID Numbers: 9248
First Posted: October 10, 2005    Key Record Dates
Last Update Posted: September 20, 2007
Last Verified: September 2007

Keywords provided by University of Kansas Medical Center:
vitamin D deficiency postmenopausal women

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
 Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents