Vitamin D Deficiency: Bone Loss and Vascular Dysfunction

This study has been completed.

Sponsor:

Collaborator:

National Osteoporosis Foundation

Information provided by:

University of Kansas Medical Center Research Institute

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:

MedlinePlus related topics: Vitamin D

Drug Information available for: Vitamin D

U.S. FDA Resources

Further study details as provided by University of Kansas Medical Center Research Institute:

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Kansas Medical Center Research Institute:


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 September 23, 2016

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