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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Meir Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01553890
First received: March 5, 2012
Last updated: March 13, 2012
Last verified: January 2012
  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: 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) ] [ Designated as safety issue: No ]

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) ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01553890     History of Changes
Other Study ID Numbers: vitamin D and Scleroderma
Study First Received: March 5, 2012
Last Updated: March 13, 2012
Health Authority: Israel: Ministry of Health

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

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

ClinicalTrials.gov processed this record on July 20, 2014