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

Oral vitamin D3 supplementation is effective to improve blood and fecal inflammatory biomarkers in Pakistani patients with moderate ulcerative colitis Objectives i. To assess the effect of oral vitamin D3 supplementation on blood and fecal inflammatory biomarkers (i.e., ESR, CRP, IL-6, and calprotectin) in Pakistani patients with moderate ulcerative colitis ii. To evaluate the impact of oral vitamin D3 supplementation on disease activity in Pakistani patients with moderate ulcerative colitis using the partial Mayo score iii. To determine the risk of vitamin D deficiency in Pakistani patients with moderate ulcerative colitis using 24-hour dietary recalls Methodology: It will be a randomized controlled trial. The participants meeting study inclusion criteria will be enrolled. Total sixty (n=60) patients with moderately active condition ulcerative colitis (based on standard clinical i.e Truelove and Witts and colonoscopic criteria) will be recruited from the Department Gastroenterology and Hepatology, Sheikh Zayed Hospital, Lahore. The duration of this clinical will be 12 weeks. Both male and female patients will be included and any patient who has taken vitamin D supplements within three months prior to the study will be excluded. Convenient sampling technique will be used to obtain data. All the participants will be divided into 2 groups: Control group and Treatment group. The control group will be asked to take their medicines only as prescribed by physician and will also be given placebo. Meanwhile, patients in the treatment group will be provided with vitamin D3 capsules (50,000 IU) and advised to consume one capsule after every two weeks (fortnightly) in addition to their medicines. The drug type and its dosage will remain same throughout clinical trial in both groups. The baseline data will comprise of demographic profile, disease duration, blood inflammatory biomarker i.e CRP, ESR, and IL-6, fecal biomarker i.e calprotectin, anthropometric measurements (weight, height, BMI), Vitamin D status. Two 24-hour dietary recalls on two non-consecutive days will also be taken before and after the study. Data regarding stool frequency and blood in stool, and physician's assessment to calculate partial Mayo score will also be collected. Patient follow-up will be conducted through phone calls and in-person meetings. After 12 weeks, the same protocol as the baseline visit (excluding the demographic profile) will be followed.

Statistical Analysis Data will be analyzed through SPSS version 25.0. Results will be presented in the form of descriptive and inferential statistics. Quantitative variables like weight, ESR, CRP, IL-6, fecal calprotectin, vitamin D status and BMI will be reported by mean ± standard deviation. In addition, gender and study groups will be assessed by using frequency and percentages. Baseline and post-study results (before and after) of every group will be compared by paired sample t-test. Results of both groups will be compared by independent sample t-test. Results of drugs-based subgroups will be compared by using one-way ANOVA. P-value ≤ 0.05 will be considered significant. Multiple logistic regression analysis will be used to control for confounding variables in the 24-hour dietary recall data.

Expected Outcomes The current study will provide valuable insights regarding the beneficial role of vitamin D3. Oral vitamin D3 may improve inflammatory biomarkers, reduces disease activity, corrects vitamin D deficiency, and enhance drug response in Pakistani patients with moderate ulcerative colitis, supporting its role as a safe and cost-effective adjunct therapy. Thus, it is expected that patient's disease symptoms and quality of life will be improved.