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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methotrexate | Active Comparator | 15 patients will take methotrexate weekly with the dose of 0.2-0.5 mg/kg/week for 3 months. |
|
| Methotrexate and Vitamin D | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methotrexate | Drug | Methotrexate 2.5 mg tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Intima Media thickness of carotid arteries from baseline | 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. | Baseline and 12 weeks |
| Change in high sensitive C- Reactive protein from baseline | Change in high sensitivity C-reactive protein (hsCRP), a soluble biomarker of systemic inflammation, after 3 months of treatment from baseline. | Baseline and 12 weeks |
| Psoriasis Area and Severity index change (PASI) | Change in PASI after 3 months of treatment from baseline | Baseline and 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eman R Said, MD | Contact | +201110066044 | dremy07@cu.edu.eg | |
| Mohamed HM El-Komy, MD | Contact | komy_m@yahoo.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28674347 | 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. | |
| 21747838 | 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. |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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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
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| Vitamin D |
| Drug |
Vitamin D 200,000 IU ampules |
|
| 30457023 | 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. |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |