RECRUITINGINTERVENTIONAL

Oral Vitamin D3 Effect on Inflammatory Biomarkers in Ulcerative Colitis Patients

Effect Of Oral Vitamin D3 Supplementation On Inflammatory Biomarkers In Patients With Ulcerative Colitis

About This Trial

This randomized controlled trial aims to evaluate the effect of oral vitamin D3 supplementation on inflammatory biomarkers and disease activity in Pakistani patients with moderate ulcerative colitis. Sixty patients will be randomized to receive either standard treatment alone/Placebo or standard treatment plus vitamin D3 (50,000 IU fortnightly) for 12 weeks. Primary outcomes include changes in blood (CRP, ESR, IL-6) and fecal (calprotectin) inflammatory biomarkers, and disease activity assessed by the partial Mayo score. Secondary outcomes include vitamin D status, dietary intake, and quality of life. The study will provide insights into the immune-modulating and anti-inflammatory role of vitamin D3 as an adjunct therapy in ulcerative colitis.

Who May Be Eligible (Plain English)

Who May Qualify: - • All patients diagnosed previously by standard clinical i.e Truelove and Witts and endoscopic/ colonoscopic criteria - Patients with moderate ulcerative colitis will be included - Both male and female patients will be included in the study - No change in the type and dosage of their medicine over the past month - Patient with severe vitamin D deficiency (\< 10 ng/mL) after screening - Patients who will provide written willing to sign a consent form - Age: 20-40 year Who Should NOT Join This Trial:• Patients using Vitamin D supplement in the 3 months before the study - Patients suffering from Crohn's disease or any known autoimmune conditions (where your immune system attacks your own body) - Patients with mild and severe ulcerative colitis - Changes in the type and dosage of the drug during the study - Pregnant and lactating women - Patients with known kidney disease - Patients with known liver disease Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * • All patients diagnosed previously by standard clinical i.e Truelove and Witts and endoscopic/ colonoscopic criteria * Patients with moderate ulcerative colitis will be included * Both male and female patients will be included in the study * No change in the type and dosage of their medicine over the past month * Patient with severe vitamin D deficiency (\< 10 ng/mL) after screening * Patients who will provide written informed consent * Age: 20-40 year Exclusion Criteria:• Patients using Vitamin D supplement in the 3 months before the study * Patients suffering from Crohn's disease or any known autoimmune disease * Patients with mild and severe ulcerative colitis * Changes in the type and dosage of the drug during the study * Pregnant and lactating women * Patients with known kidney disease * Patients with known liver disease

Treatments Being Tested

DRUG

Vitamin D3

This intervention consists of oral Vitamin D3 (cholecalciferol) capsules administered every two weeks for the duration of the study. The dose is designed to raise and maintain adequate serum 25-hydroxyvitamin D levels. Participants will receive the active supplement under supervised distribution, and adherence will be monitored through supplement logs and follow-up visits

Locations (1)

University of Veterinary & Animal Sciences, Lahore

Lahore, Punjab Province, Pakistan