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Combined Oral Vitamin D and UVB Versus UVB Alone in Treatment of Psoriasis Vulgaris

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ClinicalTrials.gov Identifier: NCT03874975
Recruitment Status : Unknown
Verified March 2019 by Meryhan Ashraf Abdelazeem, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : March 14, 2019
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Meryhan Ashraf Abdelazeem, Assiut University

Study Description
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Brief Summary:
To compare the results of vitamin D plus UVB in treatment of psoriasis vulgaris with the results of UVB alone to study the relation between serum vitamin D and PASI score before and after treatment.

Condition or disease Intervention/treatment Phase
Psoriasis Vulgaris Drug: oral vitamin D Early Phase 1

Detailed Description:

Psoriasis is a chronic immune-mediated inflammatory skin disease, with a prevalence of about 2%-3% in the general population. The primary manifestation of psoriasis most commonly manifests on the skin, although inflammatory processes can occur also in other organs .

Vitamin D, also known as the sunshine vitamin, has long been known to be a hormone that regulates calcium-phosphorous homeostasis and safeguards the integrity of the skeletal system . The epidermis is the natural source of vitamin D synthesis by the action of ultraviolet light (UV) B of the sun or other UVB source . On the other hand, evidence is accumulating that vitamin D might represent a key modulator of immune and inflammation mechanisms . Recently, a role for vitamin D in the pathogenesis of different skin diseases, including psoriasis, has been reported.

Psoriasis lesions are characterized by hyper-proliferation with incomplete differentiation of epidermal keratinocytes and decreased keratinocyte apoptosis, associated with inflammatory cellular infiltrate in both dermis and epidermis . Psoriasis Area and Severity Index (PASI) score is currently the preferred method for the assessment of the disease severity and extent .

Physiologically, the active form of vitamin D and its receptor regulate the differentiation and proliferation of keratinocytes, the balance of the cutaneous immune system and the process of apoptosis.

Several studies identified an association between polymorphisms of vitamin D receptor (VDR) and psoriasis susceptibility .The 1,25(OH)D has been shown to exert anti-proliferative effects on keratinocytes .

The exact mechanism of action of NBUVB is not known. It is proposed that it acts in the following ways: (1) Cellular DNA is converted to pyrimidine dimers which interfere with cell cycle progression, (2) alteration in cytokine production, NBUVB phototherapy as the second-line treatment for psoriasis, recommended when the topical therapy fails, is contraindicated or impractical. UVB radia- tions of wavelength 311 nm may result in the clearance of disease symptoms after just 5-8 weeks.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: 40 patients divided into two groups : group 1 :20 patients underoral vitamin D and UVB group 2 : 20 patients under uvb alone in psoriatic patients
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Combined Oral Vitamin D and UVB Versus Alone in Treatment of Psoroasis Vulgaris
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis Vitamin D

Arms and Interventions
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Intervention Details:
  • Drug: oral vitamin D
    vitamin D and UVB versus UVB alone in psoriatic patients and evaluate patients by PASI score before and after treatment and measure serum vitamin D before and after treatment
    Other Name: narrow band UVB

Outcome Measures
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Primary Outcome Measures :
  1. measure serum vitamin D before and after treatment in psoriatic patients [ Time Frame: 1 year ]

    A 3ml blood sample will be collected from the patients, then allowed to clot for 10 minutes and then centrifuged .

    Group 1: 20 patients under oral vitamin D therapy ( oral alpha one for 3 months o.25 microgram / day ) in combination with narrow band UVB settings (twice/week) Group 2 : 20 patients under narrow band UVB therapy only . c) We evaluate psoriatic patient by PASI score before and after treatment :

    ) measurment vitamin D level before and after treatment.



Secondary Outcome Measures :
  1. We evaluate psoriatic patient by PASI score before and after treatment : [ Time Frame: 1 year ]

    The body is divided into four sections (head (H) (10% of a person's skin); arms (A) (20%); trunk (T) (30%); legs (L) (40%)).

    Each of these areas is scored by itself, and then the four scores are combined into the final PASI. For each section, the percent of area of skin involved, is estimated and then transformed into a grade from 0 to 6:

    0.0% of involved area

    1.< 10% of involved area 2.10-29% of involved area 3.30-49% of involved area 4.50-69% of involved area 5.70-89% of involved area 6.90-100% of involved area



Eligibility Criteria
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Ages Eligible for Study:   10 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • : patients from 10 to 60 diagnosed to have psoriasis vulgaris

Exclusion Criteria:

  1. concomitant chronic inflammatory disease or malignancy.
  2. pregnant and lactating women.
  3. renal dysfunction.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03874975


Contacts
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Contact: meryhan abdelazeem, master 01204425625 ashrafmeryhan7@gmail.com

Sponsors and Collaborators
Assiut University
More Information
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Responsible Party: Meryhan Ashraf Abdelazeem, principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03874975    
Other Study ID Numbers: vit D and UVB in psoriasis
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Vitamin D
 Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents