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

Not Applicable

• Conditions: Psoriasis Vulgaris; Vitamin D Deficiency
• Interventions: Dietary Supplement: Vitamin D3; Drug: Placebo

• Registration Number: NCT01339741
• Lead Sponsor: Chulalongkorn University

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.

Study Timeline

• Study Start: 2011-03
• Status Verified: 2011-04
• Study First Submitted: 2011-04-20
• Study First Submitted QC: 2011-04-20
• Last Update Submitted: 2011-04-20
• Study First Posted: 2011-04-21
• Last Update Posted: 2011-04-21
• Primary Completion: 2012-02
• Study Completion: 2012-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D	Vitamin D3	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Dermatologic Life Qualify Index (DLQI)	12 weeks	Normal vitamin D level after replacement correlates with better DLQI.

Trial Locations

Locations (1)

Chotinij Lertphanichkul, M.D.; 🇹🇭 Patumwan, Bangkok, Thailand