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

Overview

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: 1. Fasting blood sugar, 2 hours postprandial and glycosylated hemoglobin 2. Liver and Kidney function tests. 3. 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. 4. Lipid profile (HDL, LDL, cholesterol and triglycerides). 5. Calculate body mass index and measure blood pressure 6. Albumin /creatinine ratio 7. 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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2019

Interventions

  • Drug: Methotrexate
    • Methotrexate 2.5 mg tablet
  • Drug: Vitamin D
    • Vitamin D 200,000 IU ampules

Arms, Groups and Cohorts

  • Active Comparator: Methotrexate
    • 15 patients will take methotrexate weekly with the dose of 0.2-0.5 mg/kg/week for 3 months.
  • Active Comparator: Methotrexate and Vitamin D
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Change in Intima Media thickness of carotid arteries from baseline
    • Time Frame: Baseline and 12 weeks
    • 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.
  • Change in high sensitive C- Reactive protein from baseline
    • Time Frame: Baseline and 12 weeks
    • Change in high sensitivity C-reactive protein (hsCRP), a soluble biomarker of systemic inflammation, after 3 months of treatment from baseline.
  • Psoriasis Area and Severity index change (PASI)
    • Time Frame: Baseline and 12 weeks
    • Change in PASI after 3 months of treatment from baseline

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cairo University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Eman Raafat Said, Lecturer of Dermatology Department, Faculty of Medicine – Cairo University
  • Overall Contact(s)
    • Eman R Said, MD, +201110066044, dremy07@cu.edu.eg

References

Furue M, Tsuji G, Chiba T, Kadono T. Cardiovascular and Metabolic Diseases Comorbid with Psoriasis: Beyond the Skin. Intern Med. 2017;56(13):1613-1619. doi: 10.2169/internalmedicine.56.8209. Epub 2017 Jul 1.

Fu LW, Vender R. Systemic role for vitamin d in the treatment of psoriasis and metabolic syndrome. Dermatol Res Pract. 2011;2011:276079. doi: 10.1155/2011/276079. Epub 2011 Jun 5.

Manolis AA, Manolis TA, Melita H, Manolis AS. Psoriasis and cardiovascular disease: the elusive link. Int Rev Immunol. 2019;38(1):33-54. doi: 10.1080/08830185.2018.1539084. Epub 2018 Nov 20.

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