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

C

Chulalongkorn University

Status

Unknown

Conditions

Vitamin D Deficiency
Psoriasis Vulgaris

Treatments

Drug: Placebo
Dietary Supplement: Vitamin D3

Study type

Interventional

Funder types

Other

Identifiers

NCT01339741
COA No. 057/2011 (Other Identifier)
PsoriasisVitaminD

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

30 participants in 2 patient groups, including a placebo group

Vitamin D
Active Comparator group
Treatment:
Dietary Supplement: Vitamin D3
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Central trial contact

Chotinij Lertphanichkul, M.D.; Marisa Pongprutthipan, M.D.

Data sourced from clinicaltrials.gov

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