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Empirical Comparative Study of Variation Blood Level Antibody Vitamin D at Scleroderma (SSc) Patients Compared Healthy Peoples (SSc)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2012 by Meir Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01553890
First Posted: March 14, 2012
Last Update Posted: March 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Meir Medical Center
  Purpose
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.

Condition Intervention
Scleroderma Other: Blood sample

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Empirical Comparative Study of Variation Blood Level Antibody Vitamin D at SSc Patients Compared Healthy Peoples

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Presence of anti vitamin D antibodies in scleroderma patients compared with control [ Time Frame: March 2013 (up to one year) ]

Secondary Outcome Measures:
  • Anti vitamin D presence and levels in serum in relation to the clinical manifestations of scleroderma [ Time Frame: March 2013 (up to one year) ]

Estimated Enrollment: 30
Study Start Date: March 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

study group

  1. patients with SSc
  2. age - 18 years old and older
  3. sign ICF control group - healthy people
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01553890     History of Changes
Other Study ID Numbers: vitamin D and Scleroderma
First Submitted: March 5, 2012
First Posted: March 14, 2012
Last Update Posted: March 14, 2012
Last Verified: January 2012

Keywords provided by Meir Medical Center:
SSc= scleroderma
ICF+ informed consent form
age 18 to 85
healthy

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Connective Tissue Diseases
Skin Diseases
Vitamin D
Antibodies
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Immunologic Factors