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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03904680
• Other study ID #: Psoriasis
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: April 2019
• Est. completion date: November 2019

Study information

• Verified date: March 2019
• Source: Cairo University
• Contact: Eman R Said, MD
• Phone: +201110066044
• Email: dremy07[@]cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: November 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Methotrexate
Methotrexate 2.5 mg tablet
• Vitamin D
Vitamin D 200,000 IU ampules

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (3)

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. — View 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. Review. — View Citation

Manolis AA, Manolis TA, Melita H, Manolis AS. Psoriasis and cardiovascular disease: the elusive link. Int Rev Immunol. 2018 Nov 20:1-22. doi: 10.1080/08830185.2018.1539084. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Psoriasis Area and Severity index change (PASI)	Change in PASI after 3 months of treatment from baseline	Baseline and 12 weeks