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

Phase 4

• Conditions: Psoriasis
• Interventions: Drug: Methotrexate; Drug: Vitamin D

• Registration Number: NCT03904680
• Lead Sponsor: Cairo University

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:

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-03
• Study Start: 2019-04
• Study First Submitted: 2019-04-03
• Study First Submitted QC: 2019-04-04
• Last Update Submitted: 2019-04-04
• Study First Posted: 2019-04-05
• Last Update Posted: 2019-04-05
• Primary Completion: 2019-10
• Study Completion: 2019-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methotrexate and Vitamin D	Methotrexate	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.
Methotrexate and Vitamin D	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.
Methotrexate	Methotrexate	15 patients will take methotrexate weekly with the dose of 0.2-0.5 mg/kg/week for 3 months.

Primary Outcome Measures

Name	Time	Method
Change in Intima Media thickness of carotid arteries from baseline	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.
Psoriasis Area and Severity index change (PASI)	Baseline and 12 weeks	Change in PASI after 3 months of treatment from baseline
Change in high sensitive C- Reactive protein from baseline	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.