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

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

Plain Language Summary

Simplified for easier understanding

This study is testing whether oral vitamin D3 supplements can reduce inflammation markers in people with moderate ulcerative colitis (a chronic bowel disease causing inflammation of the large intestine) who are severely deficient in vitamin D. **You may be eligible if...** - You are between 20 and 40 years old - You have been previously diagnosed with ulcerative colitis using clinical and endoscopic criteria - Your colitis is currently classified as moderate severity - You have not changed your ulcerative colitis medications in the past month - Your vitamin D level is severely low (below 10 ng/mL) **You may NOT be eligible if...** - You have been taking vitamin D supplements in the 3 months before the study - You have Crohn's disease or other autoimmune conditions - Your colitis is mild or severe (only moderate qualifies) - You have kidney or liver disease - You are pregnant or breastfeeding - Your medication type or dose changes during the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


Locations(1)

University of Veterinary & Animal Sciences, Lahore

Lahore, Punjab Province, Pakistan

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NCT07269223


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