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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03904680
Other study ID # Psoriasis
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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