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OpenTrials
Completed

NCT Number: NCT00235586

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.

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Key information

Age range

50 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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".

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

10 vit. D deficient subjects take vit. D for 3 months.

Procedure

Primary outcomes

  1. to determine if differences exist in vascular 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.

Secondary outcomes

  1. Vitamin D at the end of 3 months of supplementation.

Sponsors and collaborators

Lead sponsor

University of Kansas

Other

Collaborators

  • National Osteoporosis Foundation

Registry information

Important dates

Study start
2004
Study completion
2007
First posted
Oct 10, 2005
Registry last updated
Sep 20, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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