A Study of Vitamin D in Subjects With Alopecia Areata | NCT01328678

Studies
A Study of Vitamin D in Subjects With Alopecia Areata

NCT01328678

Sponsor

Avera McKennan Hospital & University Health Center

Status

Completed

Last Update Posted

Jul 8, 2011Estimated

Enrollment

10Actual

Phase

Not provided

Conditions

Alopecia Areata

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Jul 2011Actual

Completion Date

Jul 2011Actual

First Submitted Date

Jan 6, 2011

First Submission Date that Met QC Criteria

Apr 4, 2011

First Posted Date

Apr 5, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2011

Last Update Posted Date

Jul 8, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of this study is to assess the parathyroid-vitamin D-calcium axis in subjects with alopecia areata. The hypothesis behind this study is that hypovitaminosis D might contribute to the pathogenesis of alopecia areata.

Detailed Description

Alopecia Areata (AA) is a T-Cell mediated, non-scarring, polygenic, autoimmune disease of the hair follicle. It has been reported to be associated with other autoimmune diseases, especially autoimmune thyroid disease and vitiligo. It is more common in females. Recently, vitamin D deficiency has been claimed to contribute to the pathogenesis of multiple autoimmune disease. There is a strong inverse correlation between the level of 25-hydroxyvitamin D levels and the autoimmune disease in adolescents.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

10Actual

Label	Type	Description	Intervention Names
Alopecia Areata		Individuals with Alopecia Areata (AA)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Vitamin D levels will be reported in subjects and correlated with the calcium and parathyroid levels.	This study consists of a single clinic visit. After subject has completed the informed consent process and meets eligibility criteria, a blood sample will be collected. Lab results from this one-time lab draw will be evaluated.	Initial clinic visit (day 1)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men and women who are at least 18 years old
Subjects with newly diagnosed with alopecia areata

Exclusion Criteria:

Subjects who take supplemental Vitamin D, by itself or as a part of a multivitamin

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Men and women in and around the Sioux Falls area

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wael Eid, MD	Avera McKennan Hospital & University Health Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Avera Research Institute		Sioux Falls	South Dakota	57105	United States

Condition Browse Module

MeSH Terms

ID	Term
D000506	Alopecia Areata

Ancestor Terms

ID	Term
D000505	Alopecia
D007039	Hypotrichosis
D006201	Hair Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided