Studying the Effect of Methotrexate Alone Versus Methotrexate and Vitamin D on the Cardiovascular Risk of Psoriatic Patients
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
Timeline
- Start
- 2019-04
- Primary completion
- 2019-10
- Completion
- 2019-11
Publications
- Background 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.
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Methotrexate | Small molecule | 0.2 mg/kg | — |
| Comparator | Methotrexate | Small molecule | 0.5 mg/kg | — |
| Comparator | Vitamin D | Other / unclassified | 200000 iu | Intramuscular |