A Phase 4 interventional study of Methotrexate and Vitamin D in Psoriasis, sponsored by Cairo University. Status unknown. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-04-05.
Sponsored by Cairo University · Phase 4, Interventional, and Treatment
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:
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's planned enrollment of 30 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
15 patients will take methotrexate weekly with the dose of 0.2-0.5 mg/kg/week for 3 months.
Drug: Methotrexate
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.
Drug: Methotrexate · Drug: Vitamin D
Methotrexate 2.5 mg tablet
Vitamin D 200,000 IU ampules
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.
Time frame: 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.
Time frame: Baseline and 12 weeks
Psoriasis Area and Severity index change (PASI)
Change in PASI after 3 months of treatment from baseline
Time frame: Baseline and 12 weeks
No study locations are listed for this record.
This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Cairo University