search
Back to results

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

Primary Purpose

Psoriasis

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Methotrexate
Vitamin D
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis, Cardiovascular risk, Methotrexate, Vitamin D

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Methotrexate

    Methotrexate and Vitamin D

    Arm Description

    15 patients will take methotrexate weekly with the dose of 0.2-0.5 mg/kg/week for 3 months.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    Psoriasis Area and Severity index change (PASI)
    Change in PASI after 3 months of treatment from baseline

    Secondary Outcome Measures

    Full Information

    First Posted
    April 3, 2019
    Last Updated
    April 4, 2019
    Sponsor
    Cairo University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03904680
    Brief Title
    Studying the Effect of Methotrexate Alone Versus Methotrexate and Vitamin D on the Cardiovascular Risk of Psoriatic Patients
    Official Title
    Studying the Effect of Methotrexate Alone Versus Methotrexate and Vitamin D on the Cardiovascular Risk of Psoriatic Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2019 (Anticipated)
    Primary Completion Date
    October 2019 (Anticipated)
    Study Completion Date
    November 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    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

    5. Study Description

    Brief Summary
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psoriasis
    Keywords
    Psoriasis, Cardiovascular risk, Methotrexate, Vitamin D

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Methotrexate
    Arm Type
    Active Comparator
    Arm Description
    15 patients will take methotrexate weekly with the dose of 0.2-0.5 mg/kg/week for 3 months.
    Arm Title
    Methotrexate and Vitamin D
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Methotrexate
    Intervention Description
    Methotrexate 2.5 mg tablet
    Intervention Type
    Drug
    Intervention Name(s)
    Vitamin D
    Intervention Description
    Vitamin D 200,000 IU ampules
    Primary Outcome Measure Information:
    Title
    Change in Intima Media thickness of carotid arteries from baseline
    Description
    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.
    Time Frame
    Baseline and 12 weeks
    Title
    Change in high sensitive C- Reactive protein from baseline
    Description
    Change in high sensitivity C-reactive protein (hsCRP), a soluble biomarker of systemic inflammation, after 3 months of treatment from baseline.
    Time Frame
    Baseline and 12 weeks
    Title
    Psoriasis Area and Severity index change (PASI)
    Description
    Change in PASI after 3 months of treatment from baseline
    Time Frame
    Baseline and 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Eman R Said, MD
    Phone
    +201110066044
    Email
    dremy07@cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohamed HM El-Komy, MD
    Email
    komy_m@yahoo.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28674347
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    21747838
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    30457023
    Citation
    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.
    Results Reference
    background

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs