Efficacy of Vitamin D3 for the Treatment of Psoriatic Patients With Vitamin D Deficiency and Insufficiency
Primary Purpose
Psoriasis Vulgaris, Vitamin D Deficiency
Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Vitamin D3
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis Vulgaris focused on measuring Psoriasis Vulgaris, Vitamin D Deficiency, Vitamin D Insufficiency, Vitamin D Supplement, Psoriasis Area and Severity Index (PASI Score), Dermatologic Life Qualify Index (DLQI)
Eligibility 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.
Sites / Locations
- Chotinij Lertphanichkul, M.D.Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Vitamin D
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Psoriasis Area and Severity Index (PASI Score)
Normal vitamin D level after replacement correlate with improved clinical outcome (PASI Score) of psoriasis vulgaris.
Secondary Outcome Measures
Dermatologic Life Qualify Index (DLQI)
Normal vitamin D level after replacement correlates with better DLQI.
Full Information
NCT ID
NCT01339741
First Posted
April 20, 2011
Last Updated
April 20, 2011
Sponsor
Chulalongkorn University
1. Study Identification
Unique Protocol Identification Number
NCT01339741
Brief Title
Efficacy of Vitamin D3 for the Treatment of Psoriatic Patients With Vitamin D Deficiency and Insufficiency
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 Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
February 2012 (Anticipated)
Study Completion Date
February 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Chulalongkorn University
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris, Vitamin D Deficiency
Keywords
Psoriasis Vulgaris, Vitamin D Deficiency, Vitamin D Insufficiency, Vitamin D Supplement, Psoriasis Area and Severity Index (PASI Score), Dermatologic Life Qualify Index (DLQI)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3
Intervention Description
Vitamin D3, oral supplement, 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, oral route, 12 weeks
Primary Outcome Measure Information:
Title
Psoriasis Area and Severity Index (PASI Score)
Description
Normal vitamin D level after replacement correlate with improved clinical outcome (PASI Score) of psoriasis vulgaris.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Dermatologic Life Qualify Index (DLQI)
Description
Normal vitamin D level after replacement correlates with better DLQI.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chotinij Lertphanichkul, M.D.
Phone
662-256-4000
Ext
4253
Email
sea_mile@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marisa Pongprutthipan, M.D.
Phone
662-256-4000
Ext
4253
Email
dr_marisa@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chotinij Lertphanichkul, M.D.
Organizational Affiliation
Chulalongkorn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chotinij Lertphanichkul, M.D.
City
Patumwan
State/Province
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chotinij Lertphanichkul, M.D.
Phone
662-256-4000
Ext
4253
Email
sea_mile@hotmail.com
First Name & Middle Initial & Last Name & Degree
Marisa Pongprutthipan, M.D.
Phone
662-256-4000
Ext
4253
Email
dr_marisa@yahoo.com
First Name & Middle Initial & Last Name & Degree
Chotinij Lertphanichkul, M.D.
12. IPD Sharing Statement
Citations:
PubMed Identifier
17658397
Citation
Griffiths CE, Barker JN. Pathogenesis and clinical features of psoriasis. Lancet. 2007 Jul 21;370(9583):263-271. doi: 10.1016/S0140-6736(07)61128-3.
Results Reference
background
PubMed Identifier
20713823
Citation
Kurd SK, Troxel AB, Crits-Christoph P, Gelfand JM. The risk of depression, anxiety, and suicidality in patients with psoriasis: a population-based cohort study. Arch Dermatol. 2010 Aug;146(8):891-5. doi: 10.1001/archdermatol.2010.186.
Results Reference
background
PubMed Identifier
12894127
Citation
Choi J, Koo JY. Quality of life issues in psoriasis. J Am Acad Dermatol. 2003 Aug;49(2 Suppl):S57-61. doi: 10.1016/s0190-9622(03)01136-8.
Results Reference
background
PubMed Identifier
18423260
Citation
Menter A, Gottlieb A, Feldman SR, Van Voorhees AS, Leonardi CL, Gordon KB, Lebwohl M, Koo JY, Elmets CA, Korman NJ, Beutner KR, Bhushan R. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol. 2008 May;58(5):826-50. doi: 10.1016/j.jaad.2008.02.039.
Results Reference
background
PubMed Identifier
6196178
Citation
Hosomi J, Hosoi J, Abe E, Suda T, Kuroki T. Regulation of terminal differentiation of cultured mouse epidermal cells by 1 alpha,25-dihydroxyvitamin D3. Endocrinology. 1983 Dec;113(6):1950-7. doi: 10.1210/endo-113-6-1950.
Results Reference
background
PubMed Identifier
4069059
Citation
Morimoto S, Kumahara Y. A patient with psoriasis cured by 1 alpha-hydroxyvitamin D3. Med J Osaka Univ. 1985 Mar;35(3-4):51-4. No abstract available.
Results Reference
background
PubMed Identifier
17634462
Citation
Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.
Results Reference
background
PubMed Identifier
19891376
Citation
Soontrapa S, Soontrapa S, Bunyaratavej N, Rojanasthien S, Kittimanon N, Lektrakul S. Vitamin D status of Thai premenopausal women. J Med Assoc Thai. 2009 Sep;92 Suppl5:S17-20.
Results Reference
background
PubMed Identifier
7910167
Citation
Su MJ, Bikle DD, Mancianti ML, Pillai S. 1,25-Dihydroxyvitamin D3 potentiates the keratinocyte response to calcium. J Biol Chem. 1994 May 20;269(20):14723-9.
Results Reference
background
PubMed Identifier
8491153
Citation
Bikle DD, Pillai S. Vitamin D, calcium, and epidermal differentiation. Endocr Rev. 1993 Feb;14(1):3-19. doi: 10.1210/edrv-14-1-3. No abstract available.
Results Reference
background
PubMed Identifier
6332829
Citation
Rigby WF, Stacy T, Fanger MW. Inhibition of T lymphocyte mitogenesis by 1,25-dihydroxyvitamin D3 (calcitriol). J Clin Invest. 1984 Oct;74(4):1451-5. doi: 10.1172/JCI111557.
Results Reference
background
PubMed Identifier
11673504
Citation
Boonstra A, Barrat FJ, Crain C, Heath VL, Savelkoul HF, O'Garra A. 1alpha,25-Dihydroxyvitamin d3 has a direct effect on naive CD4(+) T cells to enhance the development of Th2 cells. J Immunol. 2001 Nov 1;167(9):4974-80. doi: 10.4049/jimmunol.167.9.4974.
Results Reference
background
PubMed Identifier
10679076
Citation
Penna G, Adorini L. 1 Alpha,25-dihydroxyvitamin D3 inhibits differentiation, maturation, activation, and survival of dendritic cells leading to impaired alloreactive T cell activation. J Immunol. 2000 Mar 1;164(5):2405-11. doi: 10.4049/jimmunol.164.5.2405.
Results Reference
background
PubMed Identifier
15584887
Citation
May E, Asadullah K, Zugel U. Immunoregulation through 1,25-dihydroxyvitamin D3 and its analogs. Curr Drug Targets Inflamm Allergy. 2004 Dec;3(4):377-93. doi: 10.2174/1568010042634596.
Results Reference
background
PubMed Identifier
17576242
Citation
Reichrath J. Vitamin D and the skin: an ancient friend, revisited. Exp Dermatol. 2007 Jul;16(7):618-25. doi: 10.1111/j.1600-0625.2007.00570.x.
Results Reference
background
PubMed Identifier
18854395
Citation
Bikle D. Nonclassic actions of vitamin D. J Clin Endocrinol Metab. 2009 Jan;94(1):26-34. doi: 10.1210/jc.2008-1454. Epub 2008 Oct 14.
Results Reference
background
PubMed Identifier
2164359
Citation
Kragballe K, Wildfang IL. Calcipotriol (MC 903), a novel vitamin D3 analogue stimulates terminal differentiation and inhibits proliferation of cultured human keratinocytes. Arch Dermatol Res. 1990;282(3):164-7. doi: 10.1007/BF00372616.
Results Reference
background
PubMed Identifier
8186106
Citation
Bagot M, Charue D, Lescs MC, Pamphile RP, Revuz J. Immunosuppressive effects of 1,25-dihydroxyvitamin D3 and its analogue calcipotriol on epidermal cells. Br J Dermatol. 1994 Apr;130(4):424-31. doi: 10.1111/j.1365-2133.1994.tb03373.x.
Results Reference
background
PubMed Identifier
7929921
Citation
Bruce S, Epinette WW, Funicella T, Ison A, Jones EL, Loss R Jr, McPhee ME, Whitmore C. Comparative study of calcipotriene (MC 903) ointment and fluocinonide ointment in the treatment of psoriasis. J Am Acad Dermatol. 1994 Nov;31(5 Pt 1):755-9. doi: 10.1016/s0190-9622(94)70237-3.
Results Reference
background
PubMed Identifier
3022784
Citation
Morimoto S, Yoshikawa K, Kozuka T, Kitano Y, Imanaka S, Fukuo K, Koh E, Kumahara Y. An open study of vitamin D3 treatment in psoriasis vulgaris. Br J Dermatol. 1986 Oct;115(4):421-9. doi: 10.1111/j.1365-2133.1986.tb06236.x.
Results Reference
background
Learn more about this trial
Efficacy of Vitamin D3 for the Treatment of Psoriatic Patients With Vitamin D Deficiency and Insufficiency
We'll reach out to this number within 24 hrs