Oral Vitamin D3 Effect on Inflammatory Biomarkers in Ulcerative Colitis Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-40
SponsorUniversity of Veterinary and Animal Sciences, Lahore - Pakistan

About this trial

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 criteria

Qualifiers

• 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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Vitamin D3

Treatment groups

60 Participants
are divided into 2 treatment groups