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Vitamin D Deficiency: Bone Loss and Vascular Dysfunction
This study has been completed.
Sponsor:
University of Kansas
Collaborator:
National Osteoporosis Foundation
Information provided by:
University of Kansas Medical Center
ClinicalTrials.gov Identifier:
NCT00235586
First received: October 6, 2005
Last updated: September 18, 2007
Last verified: September 2007
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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 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:
Further study details as provided by University of Kansas Medical Center:
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 |
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 (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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00235586
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 Medical Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00235586 History of Changes |
| Other Study ID Numbers: |
9248 |
| Study First Received: | October 6, 2005 |
| Last Updated: | September 18, 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 |
ClinicalTrials.gov processed this record on August 16, 2017