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Vitamin D Deficiency: Bone Loss and Vascular Dysfunction

This study has been completed.
Sponsor:
Collaborator:
National Osteoporosis Foundation
Information provided by:
University of Kansas
ClinicalTrials.gov Identifier:
NCT00235586
First received: October 6, 2005
Last updated: September 18, 2007
Last verified: September 2007
History of Changes
  Purpose

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


Condition Intervention
Postmenopausal Women
 Procedure: 10 vit. D deficient subjects take vit. D for 3 months.

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vitamin D Deficiency: Bone Loss and Vascular Dysfunction

Resource links provided by NLM:

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

Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • 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:
  • Vitamin D at the end of 3 months of supplementation.

Estimated Enrollment: 40
Study Start Date: April 2004
Study Completion Date: September 2007
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".

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00235586     History of Changes
Other Study ID Numbers: 9248
Study First Received: October 6, 2005
Last Updated: September 18, 2007
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 23, 2013