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Vitamin D Deficiency: Bone Loss and Vascular Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00235586
Recruitment Status : Completed
First Posted : October 10, 2005
Last Update Posted : September 20, 2007
Sponsor:
Collaborator:
Information provided by:

October 6, 2005
October 10, 2005
September 20, 2007
April 2004
Not Provided
  • 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.
  • 1. to determine if differences exist in vaxcular 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.
Complete list of historical versions of study NCT00235586 on ClinicalTrials.gov Archive Site
Vitamin D at the end of 3 months of supplementation.
Same as current
Not Provided
Not Provided
 
Vitamin D Deficiency: Bone Loss and Vascular Dysfunction
Vitamin D Deficiency: Bone Loss and Vascular Dysfunction
To learn if there is a connection between low vitamin D level and hardening of the arteries.
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".
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Postmenopausal Women
Procedure: 10 vit. D deficient subjects take vit. D for 3 months.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
September 2007
Not Provided

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
Sexes Eligible for Study: Female
50 Years to 90 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00235586
9248
No
Not Provided
Not Provided
Not Provided
University of Kansas
National Osteoporosis Foundation
Principal Investigator: Leland Graves, III, MD University of Kansas Medical Center
University of Kansas Medical Center
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP