The Relationship Between Vitamin D, Fingernail Thickness and Bone Density
Primary Purpose
Osteoporosis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Vitamin D
Sponsored by
About this trial
This is an interventional diagnostic trial for Osteoporosis focused on measuring Vitamin D resistance
Eligibility Criteria
Inclusion Criteria: females 25-75 years of age with no known bone disorders Exclusion Criteria: history of vertebral fractures or nonvertebral fractures without trauma prescription medications for prevention of osteoporosis (including vitamin D other than multivitamin and estrogen) history of malignancy other than basal cell or squamous cell cancer of the skin use of steroids or anticonvulsants in the 6 months prior to enrollment
Sites / Locations
- 4488 Forest Park, Suite 201
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00006196
First Posted
September 7, 2000
Last Updated
June 23, 2005
Sponsor
National Center for Research Resources (NCRR)
1. Study Identification
Unique Protocol Identification Number
NCT00006196
Brief Title
The Relationship Between Vitamin D, Fingernail Thickness and Bone Density
Study Type
Interventional
2. Study Status
Record Verification Date
December 2003
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
National Center for Research Resources (NCRR)
4. Oversight
5. Study Description
Brief Summary
Vitamin D deficiency is common in the elderly and contributes to the increased incidence of falls, hip fracture and depression in this population. An unknown number of elderly have vitamin D resistance resulting in a functional vitamin D deficiency state. Because there are no simple procedures or blood tests that identify vitamin D resistance, its prevalence and contribution to disability in the elderly is unknown. Our inability to screen for this condition precludes our ability to initiate and monitor treatment.
Previous studies indicate that fingernail thickness correlates with vitamin D status and may therefore provide a simple cost effective procedure to not only identify patients with vitamin D deficiency but also, those with vitamin D resistance. This procedure may also provide a way to monitor an individual's response to treatment.
This study is designed to demonstrate the association between fingernail thickness and vitamin D status.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Vitamin D resistance
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Vitamin D
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
females 25-75 years of age with no known bone disorders
Exclusion Criteria:
history of vertebral fractures or nonvertebral fractures without trauma
prescription medications for prevention of osteoporosis (including vitamin D other than multivitamin and estrogen)
history of malignancy other than basal cell or squamous cell cancer of the skin
use of steroids or anticonvulsants in the 6 months prior to enrollment
Facility Information:
Facility Name
4488 Forest Park, Suite 201
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
12. IPD Sharing Statement
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The Relationship Between Vitamin D, Fingernail Thickness and Bone Density
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