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

Status

Unknown

Conditions

Intervention / Treatment

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

  1. patients with SSc
  2. age - 18 years old and older
  3. 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
Other: Blood sample
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
Other: Blood sample
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

Meir Medical Center

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

Keywords

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.

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