Efficacy of Vitamin D3 for the Treatment of Psoriatic Patients With Vitamin D Deficiency and Insufficiency - Full Text View

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 Intervention Model: Parallel Assignment Masking: Double Blind (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

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis Vitamin D Vitamin D Deficiency

Drug Information available for: Cholecalciferol Vitamin D

U.S. FDA Resources

Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:

Psoriasis Area and Severity Index (PASI Score) [ Time Frame: 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) [ Time Frame: 12 weeks ]
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 (Adult, Senior)
Sexes Eligible for Study:	All
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:

Griffiths CE, Barker JN. Pathogenesis and clinical features of psoriasis. Lancet. 2007 Jul 21;370(9583):263-71. Review.

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.

Choi J, Koo JY. Quality of life issues in psoriasis. J Am Acad Dermatol. 2003 Aug;49(2 Suppl):S57-61. Review.

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.

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.

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.

Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. Review.

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.

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.

Bikle DD, Pillai S. Vitamin D, calcium, and epidermal differentiation. Endocr Rev. 1993 Feb;14(1):3-19. Review.

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.

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.

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.

May E, Asadullah K, Zügel U. Immunoregulation through 1,25-dihydroxyvitamin D3 and its analogs. Curr Drug Targets Inflamm Allergy. 2004 Dec;3(4):377-93. Review.

Reichrath J. Vitamin D and the skin: an ancient friend, revisited. Exp Dermatol. 2007 Jul;16(7):618-25. Review.

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. Review.

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.

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.

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.

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.


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 ( Other Identifier: Faculty of Medicine, Chulalongkorn University )
Study First Received:	April 20, 2011
Last Updated:	April 20, 2011

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	Vitamins Vitamin D Ergocalciferols Cholecalciferol Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents

ClinicalTrials.gov processed this record on July 07, 2017