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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 40
Healthy Volunteers: f
View:

• • 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

Locations
Other Locations
Pakistan
University of Veterinary & Animal Sciences, Lahore
RECRUITING
Lahore
Contact Information
Primary
Muhammad Barkaat Azam, PhD Scholar
barkaatazam@gmail.com
923336654554
Backup
Dr. Qaisar Raza, PhD
qaisar.raza@uvas.edu.pk
923002479044
Time Frame
Start Date: 2025-09-02
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 60
Treatments
Placebo_comparator: 1
Intervention Type: Drug Intervention Name: Placebo Capsule~Description:~An inactive oral placebo capsule that contains no Vitamin D3. It is matched in appearance and administration schedule to the active supplement and is used to maintain blinding.
Experimental: 2
Intervention Type: Drug Intervention Name: Vitamin D3~Description:~This intervention consists of oral Vitamin D3 (cholecalciferol) capsules administered every two weeks to improve vitamin D status. The dose is designed to raise serum 25(OH)D levels. Adherence will be monitored using supplement logs and follow-up visits.
Sponsors
Leads: University of Veterinary and Animal Sciences, Lahore - Pakistan

This content was sourced from clinicaltrials.gov