Evaluation of Vitamin D Levels in Psoriasis Patients

NCT01903317 | Withdrawn

• 1 other identifier: 20139554
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• The relationship between level of vitamin D and psoriasis severity

  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.

  52 Weeks

Study Arms (3)

Topical Therapy

Subjects who use topical therapy as the standard treatment of care for their psoriasis.

Other: Topical Therapy

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

Biologic Therapy

Subjects who use biologic therapy as the standard treatment of care for their psoriasis.

Other: Biologic Therapy

Interventions

Topical Therapy OTHER

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.

Topical Therapy

Phototherapy and Systemic Therapy OTHER

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.

Phototherapy and Systemic Therapy

Biologic Therapy OTHER

Subjects will continue use of biologic therapy (e.g. etanercept, adalimumab, ustekinumab) for their psoriasis as if they were not participating in this study.

Biologic Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California Irvine, Dermatology

Irvine, California, 92697, United States

Location

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.

MeSH Terms

Conditions

Psoriasis

Interventions

Therapeutics; Phototherapy; Biological Therapy

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jennifer Soung, M.D.

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lead Researcher

Study Record Dates

• First Submitted: July 3, 2013
• First Posted: July 19, 2013
• Study Start: June 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

US (1)