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

NCT ID: NCT01339741

Last Updated: 2011-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-02-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Psoriasis Vulgaris Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Vitamin D

Group Type ACTIVE_COMPARATOR

Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Vitamin D3, oral supplement, 12 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo, oral route, 12 weeks

Interventions

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Vitamin D3

Vitamin D3, oral supplement, 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo, oral route, 12 weeks

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Faculty of Medicine, Chulalongkorn University

Principal Investigators

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Chotinij Lertphanichkul, M.D.

Role: PRINCIPAL_INVESTIGATOR

Chulalongkorn University

Locations

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Chotinij Lertphanichkul, M.D.

Patumwan, Bangkok, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Chotinij Lertphanichkul, M.D.

Role: CONTACT

662-256-4000 ext. 4253

Marisa Pongprutthipan, M.D.

Role: CONTACT

662-256-4000 ext. 4253

Facility Contacts

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Chotinij Lertphanichkul, M.D.

Role: primary

662-256-4000 ext. 4253

Marisa Pongprutthipan, M.D.

Role: backup

662-256-4000 ext. 4253

References

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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.

Reference Type BACKGROUND
PMID: 17658397 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20713823 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12894127 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18423260 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6196178 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 4069059 (View on PubMed)

Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.

Reference Type BACKGROUND
PMID: 17634462 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19891376 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7910167 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8491153 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6332829 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11673504 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10679076 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15584887 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17576242 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18854395 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2164359 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8186106 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7929921 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3022784 (View on PubMed)

Other Identifiers

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COA No. 057/2011

Identifier Type: OTHER

Identifier Source: secondary_id

PsoriasisVitaminD

Identifier Type: -

Identifier Source: org_study_id

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