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

NCT03904680 | Unknown Phase 4

• 1 other identifier: Psoriasis
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.Fasting blood sugar, 2 hours postprandial and glycosylated hemoglobin
2. 2.Liver and Kidney function tests.
3. 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. 4.Lipid profile (HDL, LDL, cholesterol and triglycerides).
5. 5.Calculate body mass index and measure blood pressure
6. 6.Albumin /creatinine ratio
7. 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

Conditions

Psoriasis

Keywords

Psoriasis; Cardiovascular risk; Methotrexate; Vitamin D

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Methotrexate

ACTIVE COMPARATOR

15 patients will take methotrexate weekly with the dose of 0.2-0.5 mg/kg/week for 3 months.

Drug: Methotrexate

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.

Drug: Methotrexate; Drug: Vitamin D

Interventions

Methotrexate DRUG

Methotrexate 2.5 mg tablet

Methotrexate; Methotrexate and Vitamin D

Vitamin D DRUG

Vitamin D 200,000 IU ampules

Methotrexate and Vitamin D

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• PASI \>10

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Related Publications (3)

• 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.

  PMID: 28674347 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.

  PMID: 21747838 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.

  PMID: 30457023 BACKGROUND

MeSH Terms

Conditions

Psoriasis

Interventions

Methotrexate; Vitamin D

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Eman R Said, MD

CONTACT

+201110066044; dremy07@cu.edu.eg

Mohamed HM El-Komy, MD

CONTACT

komy_m@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Dermatology Department, Faculty of Medicine

Model Details: 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

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: April 5, 2019
• Study Start: April 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: November 1, 2019
• Last Updated: April 5, 2019

Record last verified: 2019-03