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

Vitamin D Deficiency Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01339741
• Other study ID #: PsoriasisVitaminD
• Secondary ID: COA No. 057/2011
• Status: Recruiting
• Phase: N/A
• First received: April 20, 2011
• Last updated: April 20, 2011
• Start date: March 2011
• Est. completion date: February 2012

Study information

• Verified date: April 2011
• Source: Chulalongkorn University
• Contact: Chotinij Lertphanichkul, M.D.
• Phone: 662-256-4000
• Email: sea_mile[@]hotmail.com
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Vitamin D3
Vitamin D3, oral supplement, 12 weeks

Drug:
• Placebo
Placebo, oral route, 12 weeks

Locations

Country	Name	City	State
Thailand	Chotinij Lertphanichkul, M.D.	Patumwan	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

References & Publications (20)

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. — View 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. Review. — View Citation

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

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

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

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

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. — View 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. — View 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. — View 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. — View 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. — View Citation

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

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psoriasis Area and Severity Index (PASI Score)	Normal vitamin D level after replacement correlate with improved clinical outcome (PASI Score) of psoriasis vulgaris.	12 weeks	No
Secondary	Dermatologic Life Qualify Index (DLQI)	Normal vitamin D level after replacement correlates with better DLQI.	12 weeks	No