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| ID | Type | Description | Link |
|---|---|---|---|
| COA No. 057/2011 | Other Identifier | Faculty of Medicine, Chulalongkorn University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Dietary Supplement | Vitamin D3, oral supplement, 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Dermatologic Life Qualify Index (DLQI) | Normal vitamin D level after replacement correlates with better DLQI. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chotinij Lertphanichkul, M.D. | Contact | 662-256-4000 | 4253 | sea_mile@hotmail.com |
| Marisa Pongprutthipan, M.D. | Contact | 662-256-4000 | 4253 | dr_marisa@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Chotinij Lertphanichkul, M.D. | Chulalongkorn University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chotinij Lertphanichkul, M.D. | Recruiting | Patumwan | Bangkok | 10330 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17658397 | Background | 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. | |
| 20713823 | Background | 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. |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Placebo |
| Drug |
Placebo, oral route, 12 weeks |
|
| 12894127 | Background | 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. |
| 18423260 | Background | 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. |
| 6196178 | Background | 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. |
| 4069059 | Background | 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. |
| 17634462 | Background | Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available. |
| 19891376 | Background | 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. |
| 7910167 | Background | 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. |
| 8491153 | Background | 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. |
| 6332829 | Background | 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. |
| 11673504 | Background | 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. |
| 10679076 | Background | 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. |
| 15584887 | Background | 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. |
| 17576242 | Background | 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. |
| 18854395 | Background | 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. |
| 2164359 | Background | 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. |
| 8186106 | Background | 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. |
| 7929921 | Background | 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. |
| 3022784 | Background | 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. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |