Empirical Comparative Study of Variation Blood Level Antibody Vitamin D at Scleroderma (SSc) Patients Compared Healthy Peoples (SSc)
March 13, 2012 updated by: Meir Medical Center
Empirical Comparative Study of Variation Blood Level Antibody Vitamin D at SSc Patients Compared Healthy Peoples
The aim is to find the presence of anti vitamin D antibodies in scleroderma patients and compare with control.
A second goal is anti vitamin D levels in serum of scleroderma patients in relation to the clinical manifestations of the disease.
Study Overview
Detailed Description
Blood samples from 30 scleroderma patients compared to 30 healthy peoples to reach the target of variation of the blood level vitamin D antibody between this groups
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
study group
- patients with SSc
- age - 18 years old and older
- sign ICF control group - healthy people
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Patients diagnosed with scleroderma
patients diagnosed with scleroderma, clinical and lab support
|
blood sample, venous blood, about 10 ml will be drawn from participants
|
|
Other: No disease
Blood sample, venous blood, about 10 ml will be drawn from participants
|
blood sample, venous blood, about 10 ml will be drawn from participants
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Presence of anti vitamin D antibodies in scleroderma patients compared with control
Time Frame: March 2013 (up to one year)
|
March 2013 (up to one year)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Anti vitamin D presence and levels in serum in relation to the clinical manifestations of scleroderma
Time Frame: March 2013 (up to one year)
|
March 2013 (up to one year)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (Anticipated)
November 1, 2012
Study Completion (Anticipated)
March 1, 2013
Study Registration Dates
First Submitted
March 5, 2012
First Submitted That Met QC Criteria
March 13, 2012
First Posted (Estimate)
March 14, 2012
Study Record Updates
Last Update Posted (Estimate)
March 14, 2012
Last Update Submitted That Met QC Criteria
March 13, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- vitamin D and Scleroderma
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.