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

This study is not yet open for participant recruitment.

Verified January 2012 by Meir Medical Center

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

History of Changes

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:

Genetics Home Reference related topics: systemic scleroderma

MedlinePlus related topics: Scleroderma Vitamin D

Drug Information available for: Vitamin D

U.S. FDA Resources

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

patients with SSc
age - 18 years old and older
sign ICF control group - healthy people

Contacts and Locations

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, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
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 May 23, 2013

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