Oral Vitamin D3 Effect on Inflammatory Biomarkers in Ulcerative Colitis Patients
Recruiting · NCT07269223 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Veterinary and Animal Sciences, Lahore - Pakistan
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- • 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
- 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
Where it is running
1 location listed.
- University of Veterinary & Animal Sciences, Lahore - Lahore, Punjab Province, Pakistan