Vitamin D Deficiency: Bone Loss and Vascular Dysfunction

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00235586

Enrollment

Registered

2005-10-10

Start date

2004-04-30

Completion date

2007-09-30

Last updated

2007-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postmenopausal Women

Keywords

vitamin D deficiency postmenopausal women

Brief summary

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

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.

Interventions

PROCEDURE10 vit. D deficient subjects take vit. D for 3 months.

Study design

Allocation

NON_RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

50 Years to 90 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Vitamin D at the end of 3 months of supplementation.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026