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

Cairo University (CU)

Status and phase: Unknown; Phase 4

Conditions: Psoriasis

Treatments: Drug: Vitamin D; Drug: Methotrexate

Study type: Interventional

Funder types: Other

Identifiers

NCT03904680

Psoriasis

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Methotrexate

Active Comparator group

Description:

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

Treatment:

Drug: Methotrexate

Methotrexate and Vitamin D

Active Comparator group

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.

Treatment:

Drug: Vitamin D

Drug: Methotrexate