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NCT01816711 Clinical Trial

Vitamin D Levels in Frail Elderly Patients With a Hip Fracture

Vitamin D Deficiency Clinical Trial

Official title:
Vitamin D Levels in Frail Elderly Patients With a Hip Fracture

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01816711
Other study ID # HFVD2012
Secondary ID 2007-58-0010
Status Completed
Phase
First received
Last updated
Start date January 2010
Est. completion date September 2012

Study information
Verified date April 2013
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to assess whether all frail elderly admitted with hip fracture has a vitamin D deficiency, and if s-25(OH)D deficiency increases the risk of hip fracture in frail elderly. Frail elderly are defined as being 65 years of age or older, and living in nursing homes or senior housings. The investigators' hypotheses state that: 1. Frail elderly with hip fractures will have a suboptimal level of vitamin D. 2. Frail elderly with hip fractures are more likely to have a suboptimal level of vitamin D than frail elderly without any hip fractures during the last ten years.

Description:

The study examined frail elderly patients, defined as 65 of age or older and living nursing homes or senior housings. Cases where taken from a Randomised Controlled Trial (NCT01102010), where the included where frail elderly admitted with a hip fractures to the Orthopaedic Surgery Ward at Aarhus University Hospital. Controls were frail elderly, without a hip fracture in the previous ten years, admitted to the Geriatric Ward at Aarhus University Hospital. The investigators will look at all eligible patients' files and record their serum-25(OH)D levels upon admission. According to sample size calculations 92 patients are needed in the case group, and 138 patients in the control group. The inclusion period will be from the 18th of January 2010 to the 1st of October 2012 for both groups.

Recruitment information / eligibility
Status Completed
Enrollment 447
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria, Cases: - Aged 65 or older - Living in nursing home or senior housing - Admitted with hip fracture to the Orthopaedic Ward, Aarhus University Hospital Exclusion Criteria, Cases: - No serum-25(OH)D measurement upon admission Inclusion Criteria, Controls: - Aged 65 or older - Living in nursing home or senior housing - Admitted to the Geriatric Ward, Aarhus University Hospital Exclusion Criteria, Controls: - No serum-25(OH)D measurement upon admission - Hip fracture in the previous ten years

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Reasearch Unit, Geriatric Department, Aarhus University Hospital Aarhus

Sponsors (1)
Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants With Suboptimal and Optimal Levels of Vitamin D (Serum-25(OH)D) Serum-25(OH)D was measured in a blood sample as an indicator of Vitamin D status Upon admission
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