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Development of Non-invasive Method for Quantifying Vitamin D Levels in the Body Using Spectroscopy

This study is currently recruiting participants.
Verified December 2012 by Hadassah Medical Organization
Sponsor:
Collaborator:
Ruppin Academic Center
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01770262
First received: January 13, 2013
Last updated: January 15, 2013
Last verified: December 2012
History of Changes
  Purpose

Lack in vitamin D reduces the absorption of calcium in the body, accelerates bone loss and may increase the risk of fractures due to osteoporosis. An algorithm that will allow immediate and non-invasive quantification of vitamin D levels will shorten the time of diagnosis, reduce lab costs and prevent hazards or discomfort to the patient associated with a blood test.

The goal of the study is therefore to develop a non-invasive method for quantifying vitamin D levels in the body using spectroscopy.

40 subjects will be recruited: 20 hospitalized patients in the rehabilitation department, diagnosed with osteoporosis and 20 healthy subjects. Spectroscopy will be used with visible light on the subject's skin and middle infrared (MIR) on the blood sample to find correlation with the chemical lab test results.


Condition
Osteoporosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Vitamin D levels [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    No followup will be performed.


Biospecimen Retention:   Samples Without DNA

Blood samples for quantification of vitamin D levels


Estimated Enrollment: 40
Study Start Date: December 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Osteoporosis
Hospitalized subjects diagnosed with osteoporosis
Healthy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

40 subjects aged 18 years and above will be recruited for this research: 20 patients be recruited from the population of patients in the rehabilitation department who were diagnosed with osteoporosis. Also, we will recruit 20 healthy subjects.

All participants will be able to understand the study protocol and sign a consent form independently.

Criteria

Inclusion Criteria:

-

Exclusion Criteria:

  • Pregnant
  • Cannot understand or sign a consent form independently
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01770262

Contacts
Contact: Arik Tzukert, DMD 00 972 2 6776095 arik@hadassah.org.il
Contact: Hadas Lemberg, PhD 00 972 2 6777572 lhadas@hadassah.org.il

Locations
Israel
Hadassah mount scopus Recruiting
Jerusalem, Israel, 91240
Contact: Sigal Portnoy, PhD     0097225844492     sigalp@hadassah.org.il    
Sub-Investigator: Sigal Portnoy, MSc, PhD            
Sponsors and Collaborators
Hadassah Medical Organization
Ruppin Academic Center
Investigators
Principal Investigator: Isabela Schwartz, MD Hadassah Medical Center
Study Director: Sigal Portnoy, PhD Hadassah Medical Center
Study Director: ben zion Dekel, PhD Rupin academic center
  More Information

No publications provided

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01770262     History of Changes
Other Study ID Numbers: DVitamin-HMO-CTIL
Study First Received: January 13, 2013
Last Updated: January 15, 2013
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 22, 2013