Efficacy of Vitamin D3 for the Treatment of Psoriatic Patients With Vitamin D Deficiency and Insufficiency

April 20, 2011 updated by: Chulalongkorn University

The Efficacy of Vitamin D3 for the Treatment of Chronic Plaque Type Psoriatic Patients With Vitamin D Deficiency and Insufficiency: a Randomized Controlled Trial

The purpose of this research is to study whether vitamin D supplement can improve clinical outcome (PASI score) in psoriasis vulgaris with vitamin D insufficiency and deficiency.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

While psoriasis is not a lethal disease, the disease itself can impact patients' quality of life. Nowadays there are several researches on vitamin D functions. Recently review article of vitamin D deficiency by Holick MF., stated that vitamin D can play a role in decreasing the risk of osteoporosis and other chronic diseases such as malignancy, autoimmune disease, infectious disease, cardiovascular disease, and psoriasis. Moreover, vitamin D effects on keratinocyte by decreasing abnormal cell proliferation, differentiation, apoptosis and controlling immunological process via the suppression of T-cell activation, regulation of cytokine secretion patterns, induction of regulatory T-cell, modulation of T-cell proliferation and interference with T-cell apoptosis.

Thus, our objective is to look for other alternative treatment, which may have less side effects and acceptable clinical outcomes.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Patumwan, Bangkok, Thailand, 10330
        • Recruiting
        • Chotinij Lertphanichkul, M.D.
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chotinij Lertphanichkul, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Mild to moderately severe (PASI ≤ 10), chronic plaque type psoriasis vulgaris patient, who is a new case or has at least treatment-free period as following: 4 weeks for topical calcipotriol, topical corticosteroid or 8 weeks for systemic therapy (i.e. cyclosporine, acitretin, methotrexate) or 12 weeks for Psoralen Ultraviolet A (PUVA), phototherapy or biological treatment.
  • Age 18-year-old to 70-year-old.
  • Psoriasis vulgaris patient with vitamin D insufficiency or deficiency.

Exclusion Criteria:

  • Pregnancy or Lactating mother.
  • Subject with history of major gastrointestinal surgery or gastric bypass surgery.
  • Subject with history of pustular psoriasis.
  • Subject with active psoriatic arthritis.
  • Subject with prior phototherapy within the past 3 months.
  • Subject with history of hypocholesterolemia (serum cholesterol < 120 mg/dl) or primary hyperparathyroidism.
  • Subject who regularly takes vitamin D supplement exceed 3,000 iu/day and high vitamin D diet, for example cod liver oil.
  • Subject with liver disease, cystic fibrosis, Crohn's disease, celiac sprue, renal disease, pancreatic disease, and inflammatory bowel disease.
  • Subject taking following medication: corticosteroid, orlistat, rifampicin, isoniazid, ketoconazole, statin, and cholestyramine.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo, oral route, 12 weeks
Active Comparator: Vitamin D
Dietary supplement: Vitamin D3
Vitamin D3, oral supplement, 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psoriasis Area and Severity Index (PASI Score)
Time Frame: 12 weeks
Normal vitamin D level after replacement correlate with improved clinical outcome (PASI Score) of psoriasis vulgaris.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dermatologic Life Qualify Index (DLQI)
Time Frame: 12 weeks
Normal vitamin D level after replacement correlates with better DLQI.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Investigators

  • Principal Investigator: Chotinij Lertphanichkul, M.D., Chulalongkorn University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Anticipated)

February 1, 2012

Study Completion (Anticipated)

February 1, 2012

Study Registration Dates

First Submitted

April 20, 2011

First Submitted That Met QC Criteria

April 20, 2011

First Posted (Estimate)

April 21, 2011

Study Record Updates

Last Update Posted (Estimate)

April 21, 2011

Last Update Submitted That Met QC Criteria

April 20, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PsoriasisVitaminD
  • COA No. 057/2011 (Other Identifier: Faculty of Medicine, Chulalongkorn University)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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