Clinical trial NCT03904680: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Psoriasis
Keywords: Psoriasis
Cardiovascular risk
Methotrexate
Vitamin D
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-04-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Change in Intima Media thickness of carotid arteries from baseline
timeFrame: Baseline and 12 weeks
measure: Change in high sensitive C- Reactive protein from baseline
timeFrame: Baseline and 12 weeks
measure: Psoriasis Area and Severity index change (PASI)
timeFrame: Baseline and 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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.
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.
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.