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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Chulalongkorn University.
Recruitment status was  Recruiting
Information provided by:
Chulalongkorn University Identifier:
First received: April 20, 2011
Last updated: NA
Last verified: April 2011
History: No changes posted

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.

Condition Intervention
Psoriasis Vulgaris
Vitamin D Deficiency
Dietary Supplement: Vitamin D3
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Vitamin D3 for the Treatment of Chronic Plaque Type Psoriatic Patients With Vitamin D Deficiency and Insufficiency: a Randomized Controlled Trial

Resource links provided by NLM:

Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:
  • Psoriasis Area and Severity Index (PASI Score) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Normal vitamin D level after replacement correlate with improved clinical outcome (PASI Score) of psoriasis vulgaris.

Secondary Outcome Measures:
  • Dermatologic Life Qualify Index (DLQI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Normal vitamin D level after replacement correlates with better DLQI.

Estimated Enrollment: 30
Study Start Date: March 2011
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin D Dietary Supplement: Vitamin D3
Vitamin D3, oral supplement, 12 weeks
Placebo Comparator: Placebo Drug: Placebo
Placebo, oral route, 12 weeks

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.


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01339741

Contact: Chotinij Lertphanichkul, M.D. 662-256-4000 ext 4253
Contact: Marisa Pongprutthipan, M.D. 662-256-4000 ext 4253

Chotinij Lertphanichkul, M.D. Recruiting
Patumwan, Bangkok, Thailand, 10330
Contact: Chotinij Lertphanichkul, M.D.    662-256-4000 ext 4253   
Contact: Marisa Pongprutthipan, M.D.    662-256-4000 ext 4253   
Principal Investigator: Chotinij Lertphanichkul, M.D.         
Sponsors and Collaborators
Chulalongkorn University
Principal Investigator: Chotinij Lertphanichkul, M.D. Chulalongkorn University
  More Information


Responsible Party: Chotinij Lertphanichkul, M.D., Faculty of Medicine, Chulalongkorn University Identifier: NCT01339741     History of Changes
Other Study ID Numbers: PsoriasisVitaminD, COA No. 057/2011
Study First Received: April 20, 2011
Last Updated: April 20, 2011
Health Authority: Thailand: Ethical Committee

Keywords provided by Chulalongkorn University:
Psoriasis Vulgaris
Vitamin D Deficiency
Vitamin D Insufficiency
Vitamin D Supplement
Psoriasis Area and Severity Index (PASI Score)
Dermatologic Life Qualify Index (DLQI)

Additional relevant MeSH terms:
Vitamin D Deficiency
Deficiency Diseases
Nutrition Disorders
Vitamin D
Bone Density Conservation Agents
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs processed this record on March 03, 2015