NCT00235586

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 6, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 10, 2005

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

September 20, 2007

Status Verified

September 1, 2007

First QC Date

October 6, 2005

Last Update Submit

September 18, 2007

Conditions

Postmenopausal Women

Keywords

vitamin D deficiency postmenopausal women

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

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

Interventions

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

Eligibility Criteria

Age50 Years - 90 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Females ages 50-70 with ability to give informed consent
  • One year past last menstrual period
  • women with Vitamin D levels \< 15 mg/ml
  • women with Vitamin D levels \> 30 mg/ml

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Study Officials

  • Leland Graves, III, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 6, 2005

First Posted

October 10, 2005

Study Start

April 1, 2004

Study Completion

September 1, 2007

Last Updated

September 20, 2007

Record last verified: 2007-09

Locations

US(1)