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
Sponsor:
Information provided by:
Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT01339741
First received: April 20, 2011
Last updated: NA
Last verified: April 2011
History: No changes posted

April 20, 2011
April 20, 2011
March 2011
February 2012   (final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
Dermatologic Life Qualify Index (DLQI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Normal vitamin D level after replacement correlates with better DLQI.
Same as current
Not Provided
Not Provided
 
Efficacy of Vitamin D3 for the Treatment of Psoriatic Patients With Vitamin D Deficiency and Insufficiency
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Psoriasis Vulgaris
  • Vitamin D Deficiency
  • Dietary Supplement: Vitamin D3
    Vitamin D3, oral supplement, 12 weeks
  • Drug: Placebo
    Placebo, oral route, 12 weeks
  • Active Comparator: Vitamin D
    Intervention: Dietary Supplement: Vitamin D3
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
February 2012
February 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact: Chotinij Lertphanichkul, M.D. 662-256-4000 ext 4253 sea_mile@hotmail.com
Contact: Marisa Pongprutthipan, M.D. 662-256-4000 ext 4253 dr_marisa@yahoo.com
Thailand
 
NCT01339741
PsoriasisVitaminD, COA No. 057/2011
Not Provided
Chotinij Lertphanichkul, M.D., Faculty of Medicine, Chulalongkorn University
Chulalongkorn University
Not Provided
Principal Investigator: Chotinij Lertphanichkul, M.D. Chulalongkorn University
Chulalongkorn University
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP