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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-30

Study Completion Date

2019-11-30

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:

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

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Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Methotrexate

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

Group Type ACTIVE_COMPARATOR

Methotrexate

Intervention Type DRUG

Methotrexate 2.5 mg tablet

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.

Group Type ACTIVE_COMPARATOR

Methotrexate

Intervention Type DRUG

Methotrexate 2.5 mg tablet

Vitamin D

Intervention Type DRUG

Vitamin D 200,000 IU ampules

Interventions

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Methotrexate

Methotrexate 2.5 mg tablet

Intervention Type DRUG

Vitamin D

Vitamin D 200,000 IU ampules

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No