RecruitingNot ApplicableNCT07269223

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

Sponsor

University of Veterinary and Animal Sciences, Lahore - Pakistan

Enrollment

60 participants

Start Date

Sep 2, 2025

Study Type

INTERVENTIONAL

Conditions

Ulcerative Colitis (UC)

Summary

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.

Eligibility

Min Age: 20 YearsMax Age: 40 Years

Inclusion Criteria7

• 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 Criteria6

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

Interventions

DRUGVitamin 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