NCT01770262

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

December 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 13, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 17, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 5, 2016

Status Verified

December 1, 2012

Enrollment Period

1 year

First QC Date

January 13, 2013

Last Update Submit

January 4, 2016

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • Vitamin D levels

    No followup will be performed.

    At baseline

Study Arms (2)

Osteoporosis

Hospitalized subjects diagnosed with osteoporosis

Healthy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may not qualify if:

  • Pregnant
  • Cannot understand or sign a consent form independently

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples for quantification of vitamin D levels

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Mordechi Hallak, MD, MPA

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

  • Sigal Portnoy, PhD

    Hadassah Medical Organization

    STUDY DIRECTOR

  • ben zion Dekel, PhD

    Rupin academic center

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2013

First Posted

January 17, 2013

Study Start

December 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 5, 2016

Record last verified: 2012-12

Locations

IL(1)