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Evaluation of Vitamin D Levels in Psoriasis Patients

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ClinicalTrials.gov Identifier: NCT01903317
Recruitment Status : Withdrawn (No subjects enrolled)
First Posted : July 19, 2013
Last Update Posted : October 12, 2015
Sponsor:
Information provided by (Responsible Party):
Patty Summerville, University of California, Irvine

Brief Summary:
The purpose of this research study is to find out more about the relationship between vitamin D and psoriasis.

Condition or disease Intervention/treatment
Psoriasis Other: Topical Therapy Other: Phototherapy and Systemic Therapy Other: Biologic Therapy

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Vitamin D Levels in Psoriasis Patients
Study Start Date : June 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis Vitamin D
Drug Information available for: Vitamin D

Group/Cohort Intervention/treatment
Topical Therapy
Subjects who use topical therapy as the standard treatment of care for their psoriasis.
Other: Topical Therapy
Subjects will continue use of topical therapy (e.g. topical corticosteroids, keratolytic agents, anthralin, coal tar, vitamin D analogs, retinoids) for their psoriasis as if they were not participating in this study.

Phototherapy and Systemic Therapy
Subjects who use phototherapy and systemic therapy as the standard treatment of care for their psoriasis.
Other: Phototherapy and Systemic Therapy
Subjects will continue use of phototherapy (e.g. ultraviolet B [UVB] or ultraviolet A and psoralen [PUVA]) and systemic therapy (e.g. methotrexate, cyclosporine) for their psoriasis as if they were not participating in this study.

Biologic Therapy
Subjects who use biologic therapy as the standard treatment of care for their psoriasis.
Other: Biologic Therapy
Subjects will continue use of biologic therapy (e.g. etanercept, adalimumab, ustekinumab) for their psoriasis as if they were not participating in this study.




Primary Outcome Measures :
  1. The relationship between level of vitamin D and psoriasis severity [ Time Frame: 52 Weeks ]
    Subjects will have their disease severity evaluated and a vitamin D level drawn at Baseline (prior to initiating treatment), Week 12, Week 24, and Week 52.


Biospecimen Retention:   Samples Without DNA
For all Vitamin D level testing in this protocol, the Vitamin D 25-hydroxy level will be drawn, which involves 0.5mL of blood per draw.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be recruited from an outpatient population of subjects with psoriasis from Dr. Jennifer Soung's clinic at the Gottschalk Medical Plaza at the University of California, Irvine.
Criteria

Inclusion Criteria:

  1. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.
  2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  3. Be at least 18 years of age at time of informed consent.
  4. Have had a diagnosis of plaque-type psoriasis (psoriasis vulgaris).
  5. Subject is about to start a new kind of therapeutic treatment, either topical, phototherapy, systemic, or biologic agent.

Exclusion Criteria:

  1. Subject is not over 18 years of age.
  2. Subject cannot understand or follow directions.
  3. Subject is a female of child-bearing potential and unwilling to use a form of highly effective birth control.
  4. Subject is pregnant or planning to get pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903317


Locations
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United States, California
University of California Irvine, Dermatology
Irvine, California, United States, 92697
Sponsors and Collaborators
University of California, Irvine
Investigators
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Principal Investigator: Jennifer Soung, M.D. University of California, Irvine

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Responsible Party: Patty Summerville, Lead Researcher, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01903317     History of Changes
Other Study ID Numbers: 2013-9554
First Posted: July 19, 2013    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents