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Oral Vitamin D3 Effect on Inflammatory Biomarkers in Ulcerative Colitis Patients

NCT07269223 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-12-17

No results posted yet for this study

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.

Conditions

  • Ulcerative Colitis (UC)

Interventions

DRUG

Vitamin D3

This 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

Sponsors & Collaborators

  • University of Veterinary and Animal Sciences, Lahore - Pakistan

    lead OTHER

Principal Investigators

  • Dr. Qaisar Raza, PhD · UNIVERSITY OF VETERINARY & ANIMAL SCIENCES, LAHORE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-02
Primary Completion
2025-12-15
Completion
2025-12-30

Countries

  • Pakistan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07269223 on ClinicalTrials.gov