Alopecia AreataNCT01328678
A Study of Vitamin D in Subjects With Alopecia Areata
An observational study of Alopecia Areata, run by Avera McKennan Hospital & University Health Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alopecia Areata
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Jul 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men and women in and around the Sioux Falls area
Who may be able to join
- Men and women who are at least 18 years old
- Subjects with newly diagnosed with alopecia areata
Who cannot join
- Subjects who take supplemental Vitamin D, by itself or as a part of a multivitamin
Trial locations and contacts
1 site in 1 country.
United States1 site
Avera Research Institute
Sioux Falls, South Dakota, 57105
About this study
Official title: A Pilot Study of Vitamin D in Subjects With Alopecia Areata
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.
Read the 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.
- Conditions
- Alopecia Areata
- Keywords
- Alopecia Areata, Vitamin D, Parathyroid, Calcium
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Alopecia Areata | Individuals with Alopecia Areata (AA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Initial clinic visit (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2011 (estimated)
- Study startAug 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avera McKennan Hospital & University Health Center
- Sponsor type
- University, hospital or other
- Investigators
- Wael Eid, MD, Principal investigator, Avera McKennan Hospital & University Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01328678
- Sponsor's protocol ID
- ARI-1270-Alopecia
- Status last verified
- Jul 2011
- First submitted
- 6 Jan 2011
- Last updated
- 8 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Vitamin D in Subjects With Alopecia Areata
- ClinicalTrials.gov ID
- NCT01328678
- Acronym / sponsor ID
- ARI-1270-Alopecia
- Conditions
- Alopecia Areata
- Keywords
- Alopecia Areata, Vitamin D, Parathyroid, Calcium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Avera McKennan Hospital & University Health CenterUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 5 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alopecia Areata | – | –Individuals with Alopecia Areata (AA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women in and around the Sioux Falls area
Key inclusion criteria (2 listed)
- Men and women who are at least 18 years old
- Subjects with newly diagnosed with alopecia areata
Key exclusion criteria (1 listed)
- Subjects who take supplemental Vitamin D, by itself or as a part of a multivitamin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vitamin D levels will be reported in subjects and correlated with the calcium and parathyroid levels.
Time frame: Initial clinic visit (day 1)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wael Eid, MD principal investigator
Avera McKennan Hospital & University Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alopecia Areata, run by Avera McKennan Hospital & University Health Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin D levels will be reported in subjects and correlated with the calcium and parathyroid levels. (time frame: Initial clinic visit (day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2011.