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
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis, Cardiovascular risk, Methotrexate, Vitamin D
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
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
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
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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
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Studying the Effect of Methotrexate Alone Versus Methotrexate and Vitamin D on the Cardiovascular Risk of Psoriatic Patients
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