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Oral Vitamin D3 Effect on Inflammatory Biomarkers in Ulcerative Colitis Patients

RecruitingNAAges 20 Years - 40 YearsAllUniversity of Veterinary and Animal Sciences, Lahโ€ฆ
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * โ€ข 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:โ€ข 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
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What it tests

  • Vitamin D3
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Where

1 site
University of Veterinary & Animal Sciences, Lahore
Lahore, Pakistan
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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