Back to resultsEmpirical Comparative Study of Variation Blood Level Antibody Vitamin D at Scleroderma (SSc) Patients Compared Healthy Peoples (SSc)
Primary Purpose
Scleroderma
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Blood sample
Sponsored by
About this trial
This is an interventional diagnostic trial for Scleroderma focused on measuring SSc= scleroderma, ICF+ informed consent form, age 18 to 85, healthy
Eligibility Criteria
Inclusion Criteria:
study group
- patients with SSc
- age - 18 years old and older
- sign ICF control group - healthy people
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Patients diagnosed with scleroderma
No disease
Arm Description
patients diagnosed with scleroderma, clinical and lab support
Blood sample, venous blood, about 10 ml will be drawn from participants
Outcomes
Primary Outcome Measures
Presence of anti vitamin D antibodies in scleroderma patients compared with control
Secondary Outcome Measures
Anti vitamin D presence and levels in serum in relation to the clinical manifestations of scleroderma
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01553890
Brief Title
Empirical Comparative Study of Variation Blood Level Antibody Vitamin D at Scleroderma (SSc) Patients Compared Healthy Peoples
Acronym
SSc
Official Title
Empirical Comparative Study of Variation Blood Level Antibody Vitamin D at SSc Patients Compared Healthy Peoples
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
November 2012 (Anticipated)
Study Completion Date
March 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scleroderma
Keywords
SSc= scleroderma, ICF+ informed consent form, age 18 to 85, healthy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients diagnosed with scleroderma
Arm Type
Other
Arm Description
patients diagnosed with scleroderma, clinical and lab support
Arm Title
No disease
Arm Type
Other
Arm Description
Blood sample, venous blood, about 10 ml will be drawn from participants
Intervention Type
Other
Intervention Name(s)
Blood sample
Intervention Description
blood sample, venous blood, about 10 ml will be drawn from participants
Primary Outcome Measure Information:
Title
Presence of anti vitamin D antibodies in scleroderma patients compared with control
Time Frame
March 2013 (up to one year)
Secondary Outcome Measure Information:
Title
Anti vitamin D presence and levels in serum in relation to the clinical manifestations of scleroderma
Time Frame
March 2013 (up to one year)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
study group
patients with SSc
age - 18 years old and older
sign ICF control group - healthy people
12. IPD Sharing Statement
Learn more about this trial
Empirical Comparative Study of Variation Blood Level Antibody Vitamin D at Scleroderma (SSc) Patients Compared Healthy Peoples
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