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

Sponsor

Chulalongkorn University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01339741

Collaborator

(none)

Enrollment

Location

Arms

11.1

Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis Vulgaris Vitamin D Deficiency	Dietary Supplement: Vitamin D3 Drug: Placebo	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, 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

Study Start Date :

Mar 1, 2011

Anticipated Primary Completion Date :

Feb 1, 2012

Anticipated Study Completion Date :

Feb 1, 2012

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Vitamin D

Dietary Supplement: Vitamin D3

Vitamin D3, oral supplement, 12 weeks

Placebo Comparator: Placebo

Drug: Placebo

Placebo, oral route, 12 weeks

Outcome Measures

Primary Outcome Measures

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

Dermatologic Life Qualify Index (DLQI) [12 weeks]
Normal vitamin D level after replacement correlates with better DLQI.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.