Psoriasis Vulgaris, Vitamin D Deficiency
Conditions
Keywords
Psoriasis Vulgaris, Vitamin D Deficiency, Vitamin D Insufficiency, Vitamin D Supplement, Psoriasis Area and Severity Index (PASI Score), Dermatologic Life Qualify Index (DLQI)
Brief summary
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.
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.
Interventions
DIETARY_SUPPLEMENTVitamin D3
Vitamin D3, oral supplement, 12 weeks
DRUGPlacebo
Placebo, oral route, 12 weeks
Sponsors
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psoriasis Area and Severity Index (PASI Score) | 12 weeks | Normal vitamin D level after replacement correlate with improved clinical outcome (PASI Score) of psoriasis vulgaris. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dermatologic Life Qualify Index (DLQI) | 12 weeks | Normal vitamin D level after replacement correlates with better DLQI. |
Countries
Thailand
Contacts
Primary ContactChotinij Lertphanichkul, M.D.
Backup ContactMarisa Pongprutthipan, M.D.
Outcome results
None listed