Oral Vitamin D3 Effect on Inflammatory Biomarkers in Ulcerative Colitis Patients

NCT07269223 | Recruiting

• 2 other identifiers: UniversityUVASUVAS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Ulcerative Colitis; Vitamin D; Immune modulation

Outcome Measures

Primary Outcomes (4)

• Name: Change in ESR Unit: mm/hr

  Standard Westergren method

  Baseline and week 12

• Name: Change in CRP Unit: mg/L

  Measured by immunoturbidimetry

  Baseline to 12 weeks

• Name: Change in serum IL-6 Unit: pg/mL

  Measured using ELISA

  Baseline to 12 weeks

• Change in fecal calprotectin concentration Unit: µg/g

  Fecal calprotectin measured using quantitative ELISA.

  Baseline and 12 weeks

Secondary Outcomes (1)

• Name: Change in serum 25-hydroxyvitamin D (25-OH Vitamin D) levels Unit: ng/mL

  Baseline and 12 weeks

Study Arms (2)

1

PLACEBO COMPARATOR

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."

Drug: Vitamin D3

2

EXPERIMENTAL

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."

Drug: Vitamin D3

Interventions

Vitamin D3 DRUG

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

1; 2

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Veterinary and Animal Sciences, Lahore - Pakistan: lead

Study Sites (1)

University of Veterinary & Animal Sciences, Lahore

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Dr. Qaisar Raza, PhD

  UNIVERSITY OF VETERINARY & ANIMAL SCIENCES, LAHORE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Barkaat Azam, PhD Scholar

CONTACT

923336654554; barkaatazam@gmail.com

Dr. Qaisar Raza, PhD

CONTACT

923002479044; qaisar.raza@uvas.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomly assigned in a 1:1 ratio to either the treatment group (Vitamin D3 supplementation plus standard care) or the control group (standard care only). Both groups will be followed concurrently for 12 weeks to assess changes in inflammatory biomarkers, disease activity, and vitamin D status.

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 8, 2025
• Study Start: September 2, 2025
• Primary Completion: December 15, 2025
• Study Completion: December 30, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)