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
  Purpose

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.

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01339741

Contacts
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

Locations
Thailand
Chotinij Lertphanichkul, M.D. Recruiting
Patumwan, Bangkok, Thailand, 10330
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   
Principal Investigator: Chotinij Lertphanichkul, M.D.         
Sponsors and Collaborators
Chulalongkorn University
Investigators
Principal Investigator: Chotinij Lertphanichkul, M.D. Chulalongkorn University
  More Information

Publications:

Responsible Party: Chotinij Lertphanichkul, M.D., Faculty of Medicine, Chulalongkorn University
ClinicalTrials.gov 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:
Psoriasis
Vitamin D Deficiency
Skin Diseases, Papulosquamous
Skin Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 17, 2014