Studying the Effect of Methotrexate Alone Versus Methotrexate and Vitamin D on the Cardiovascular Risk of Psoriatic Patients

Study Overview
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Brief Summary
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The prevalence of cardiovascular risk in psoriasis has been reported in previous studies.Various studies have also shown that systemic treatments for psoriasis, including methotrexate, may significantly decrease this cardiovascular risk. We proposed that the addition of vitamin D may not only improve the therapeutic effect of various treatment modalities but also increase its effect on decreasing the cardiovascular risk in psoriasis. So our aim of work is to assess the Clinical improvement and cardiovascular risks in psoriatic patients after treatment with methotrexate alone with the dose of 0.2-0.5 mg/kg/week for three months in comparison to combined methotrexate with the same dose and vitamin D injection with the dose of 200,000 IU per month for 3 months. Each patient will do the following before starting treatment& after 3 months: Fasting blood sugar, 2 hours postprandial and glycosylated hemoglobin Liver and Kidney function tests. Cardiovascular risk assessment by measuring the intima media thickness of carotid arteries using Carotid duplex and High sensitive C reactive protein measuring by particle-enhanced immunonephelometry on autoanalyzer. Lipid profile (HDL, LDL, cholesterol and triglycerides). Calculate body mass index and measure blood pressure Albumin /creatinine ratio Serum vitamin D level. Clinical response will be evaluated by Psoriasis Area and Severity index (PASI) & Psoriasis Disability Index (PDI) scores before and after 3 months of treatment

Official Title
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Studying the Effect of Methotrexate Alone Versus Methotrexate and Vitamin D on the Cardiovascular Risk of Psoriatic Patients

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Methotrexate
* Drug: Vitamin D


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Psoriasis patient not on systemic treatment at least for 3 months before inclusion in the study PASI >10 Exclusion Criteria: Patients with autoimmune diseases. Patients with liver disease or kidney diseases Patients with Diabetes mellitus Females in child bearing period not using methods of contraception Any associated dermatological disease Evidence of infection Pregnancy and lactation Patients taking vitamin D

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The patients will be randomly divided into 2 groups: Group A: 15 patients will take methotrexate weekly for 3 months for the treatment of psoriasis. Group B: will take methotrexate weekly in addition to Vitamin D injections monthly for 3 months for treatment of psoriasis
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Methotrexate<br>15 patients will take methotrexate weekly with the dose of 0.2-0.5 mg/kg/week for 3 months. | Drug: Methotrexate<br>* Methotrexate 2.5 mg tablet<br>|
| Active Comparator: Methotrexate and Vitamin D<br>15 patients will take methotrexate weekly with the dose of 0.2-0.5 mg/kg/week and Vitamin D intramuscular injections with the dose of 200,000 IU per month for 3 months. | Drug: Methotrexate<br>* Methotrexate 2.5 mg tablet<br>Drug: Vitamin D<br>* Vitamin D 200,000 IU ampules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Intima Media thickness of carotid arteries from baseline | Intima Media thickness of left and right common carotid arteries, bulb of common carotid arteries and internal carotid arteries as measured by carotid duplex before starting the treatment and after 3 months of treatment. | Baseline and 12 weeks | 
| Change in high sensitive C- Reactive protein from baseline | Change in high sensitivity C-reactive protein (hsCRP), a soluble biomarker of systemic inflammation, after 3 months of treatment from baseline. | Baseline and 12 weeks | 
| Psoriasis Area and Severity index change (PASI) | Change in PASI after 3 months of treatment from baseline | Baseline and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriasis, Cardiovascular risk, Methotrexate, Vitamin D