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.
• 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
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
Parallel
Vitamin D3
DrugThis 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
Name: Change in ESR Unit: mm/hr
Standard Westergren method
Name: Change in CRP Unit: mg/L
Measured by immunoturbidimetry
Name: Change in serum IL-6 Unit: pg/mL
Measured using ELISA
Change in fecal calprotectin concentration Unit: µg/g
Fecal calprotectin measured using quantitative ELISA.
Name: Change in serum 25-hydroxyvitamin D (25-OH Vitamin D) levels Unit: ng/mL
Serum 25-OH Vitamin D levels will be measured using chemiluminescent immunoassay
Click on the lead sponsor to view all of their trials.
