NCT01553890

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2012

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 14, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

March 14, 2012

Status Verified

January 1, 2012

Enrollment Period

8 months

First QC Date

March 5, 2012

Last Update Submit

March 13, 2012

Conditions

Scleroderma

Keywords

SSc= sclerodermaICF+ informed consent formage 18 to 85healthy

Outcome Measures

Primary Outcomes (1)

  • Presence of anti vitamin D antibodies in scleroderma patients compared with control

    March 2013 (up to one year)

Secondary Outcomes (1)

  • Anti vitamin D presence and levels in serum in relation to the clinical manifestations of scleroderma

    March 2013 (up to one year)

Study Arms (2)

Patients diagnosed with scleroderma

OTHER

patients diagnosed with scleroderma, clinical and lab support

Other: Blood sample

No disease

OTHER

Blood sample, venous blood, about 10 ml will be drawn from participants

Other: Blood sample

Interventions

Blood sampleOTHER

blood sample, venous blood, about 10 ml will be drawn from participants

No diseasePatients diagnosed with scleroderma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Scleroderma, Diffuse

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Scleroderma, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2012

First Posted

March 14, 2012

Study Start

March 1, 2012

Primary Completion

November 1, 2012

Study Completion

March 1, 2013

Last Updated

March 14, 2012

Record last verified: 2012-01