Vitamin D Deficiency: Bone Loss and Vascular Dysfunction - Full Text View

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.

ChemIDplus related topics:

Vitamin D Ergocalciferol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study

Official Title:	Vitamin D Deficiency: Bone Loss and Vascular Dysfunction

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

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

Keywords provided by University of Kansas:

vitamin D deficiency postmenopausal women

Study placed in the following topic categories:

Vitamin D Deficiency

Vitamin D

Malnutrition

Avitaminosis

Ergocalciferols

Nutrition Disorders

Deficiency Diseases

Additional relevant MeSH terms:

Growth Substances

Vitamins

Physiological Effects of Drugs

Bone Density Conservation Agents

Micronutrients

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2008

Sponsors and Collaborators:	University of Kansas National Osteoporosis Foundation
Information provided by:	University of Kansas
ClinicalTrials.gov Identifier:	NCT00235586