NCT01339741

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 21, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

April 21, 2011

Status Verified

April 1, 2011

Enrollment Period

11 months

First QC Date

April 20, 2011

Last Update Submit

April 20, 2011

Conditions

Psoriasis VulgarisVitamin D Deficiency

Keywords

Psoriasis VulgarisVitamin D DeficiencyVitamin D InsufficiencyVitamin D SupplementPsoriasis Area and Severity Index (PASI Score)Dermatologic Life Qualify Index (DLQI)

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Dermatologic Life Qualify Index (DLQI)

    12 weeks

Study Arms (2)

Vitamin D

ACTIVE COMPARATOR
Dietary Supplement: Vitamin D3

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Vitamin D3DIETARY_SUPPLEMENT

Vitamin D3, oral supplement, 12 weeks

Vitamin D
PlaceboDRUG

Placebo, oral route, 12 weeks

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chotinij Lertphanichkul, M.D.

Patumwan, Bangkok, 10330, Thailand

RECRUITING

Related Publications (20)

  • 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.

    PMID: 17658397BACKGROUND

  • 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.

    PMID: 20713823BACKGROUND

  • 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.

    PMID: 12894127BACKGROUND

  • 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.

    PMID: 18423260BACKGROUND

  • 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.

    PMID: 6196178BACKGROUND

  • 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.

    PMID: 4069059BACKGROUND

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

    PMID: 17634462BACKGROUND

  • 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.

    PMID: 19891376BACKGROUND

  • 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.

    PMID: 7910167BACKGROUND

  • 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.

    PMID: 8491153BACKGROUND

  • 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.

    PMID: 6332829BACKGROUND

  • 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.

    PMID: 11673504BACKGROUND

  • 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.

    PMID: 10679076BACKGROUND

  • 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.

    PMID: 15584887BACKGROUND

  • 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.

    PMID: 17576242BACKGROUND

  • 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.

    PMID: 18854395BACKGROUND

  • 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.

    PMID: 2164359BACKGROUND

  • 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.

    PMID: 8186106BACKGROUND

  • 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.

    PMID: 7929921BACKGROUND

  • 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.

    PMID: 3022784BACKGROUND

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Chotinij Lertphanichkul, M.D.

    Chulalongkorn University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chotinij Lertphanichkul, M.D.

CONTACT

662-256-4000sea_mile@hotmail.com

Marisa Pongprutthipan, M.D.

CONTACT

662-256-4000dr_marisa@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 20, 2011

First Posted

April 21, 2011

Study Start

March 1, 2011

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

April 21, 2011

Record last verified: 2011-04

Locations

TH(1)