Atorvastatin in Patients With Ulcerative Colitis

NCT05561062 | Completed Phase 2

• 1 other identifier: 9/22021
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Ulcerative colitis (UC) is an idiopathic, chronic inflammatory disease characterized by diffused inflammation of the colon and rectum mucosa; however, the exact underlying mechanisms of UC remain poorly understood. Statins exert numerous pleiotropic effects including anti-inflammatory, antioxidant properties, endothelial function improvement, and immunomodulation independent of their basic lipid-lowering property.

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• Improvement in health related quality of life

  HRQL questionnaire will be assessed according to a short-form (SF-36) questionnaire. The SF-36 is an indicator of overall health status and contains 10 items. The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100.

  6 months

Secondary Outcomes (1)

• changes in the level of inflammatory biomarkers

  6 months

Study Arms (2)

Control Group

NO INTERVENTION

This group will take 1 g mesalamine three times daily

Atorvastatin group

ACTIVE COMPARATOR

This group will take 1 g mesalamine three times daily and atorvastatin 80 mg once daily

Drug: Atorvastatin 80mg

Interventions

Atorvastatin 80mg DRUG

Atorvastatin is one of the most effective drugs used to reduce intracellular cholesterol synthesis. it exerts numerous pleiotropic effects including anti-inflammatory, antioxidant properties, endothelial function improvement, and immunomodulation independent of its basic lipid-lowering properties

Atorvastatin group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Both male and female will be included
• Negative pregnancy test and effective contraception

You may not qualify if:

• Breastfeeding
• Significant liver and kidney function abnormalities
• Colorectal cancer patients
• Patients with severe UC
• Patients taking rectal or systemic steroids
• Patients taking immunosuppressives or biological therapies

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Medicine, Mansoura University

Al Mansurah, 35511, Egypt

Location

Related Publications (1)

• Alarfaj SJ, El-Haggar SM, Hegazy SK, Maher MM, Bahgat MM, Elmasry TA, Alrubia S, Alsegiani AS, Bahaa MM. Effect of a high dose atorvastatin as adjuvant therapy to mesalamine in attenuating inflammation and symptoms in patients with ulcerative colitis: a randomized controlled pilot study. Front Med (Lausanne). 2025 Jan 22;11:1490178. doi: 10.3389/fmed.2024.1490178. eCollection 2024.

  PMID: 39911672 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: September 30, 2022
• Study Start: December 1, 2022
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: August 11, 2025

Record last verified: 2025-08

Locations

EG (1)