Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Skin Diseases
Skin Diseases, Papulosquamous
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014