Oral vitamin D3 to reduce inflammation in ulcerative colitis
Effect Of Oral Vitamin D3 Supplementation On Inflammatory Biomarkers In Patients With Ulcerative Colitis
This trial will try giving fortnightly oral vitamin D3 alongside usual care to adults aged 20–40 with moderate ulcerative colitis in Pakistan to see if it lowers blood and stool markers of inflammation and improves symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 20 Years to 40 Years |
| Sex | All |
| Sponsor | University of Veterinary and Animal Sciences, Lahore - Pakistan Academic / other |
| Locations | 1 site (Lahore, Punjab Province) |
| Trial ID | NCT07269223 on ClinicalTrials.gov |
What this trial studies
This is a randomized, placebo-controlled trial enrolling 60 adults (age 20–40) with moderate ulcerative colitis and severe vitamin D deficiency to receive either standard treatment plus oral vitamin D3 (50,000 IU every two weeks) or standard treatment with placebo for 12 weeks. Primary outcomes are changes in blood inflammatory markers (CRP, ESR, IL‑6), fecal calprotectin, and disease activity by the partial Mayo score. Secondary outcomes include serum vitamin D status, dietary intake, and quality of life measures. The trial is being conducted at the University of Veterinary & Animal Sciences in Lahore and focuses on the immune‑modulating, anti‑inflammatory effects of vitamin D3 as an adjunct to usual therapy.
Who should consider this trial
Good fit: Ideal candidates are adults 20–40 years old with moderate ulcerative colitis, severe vitamin D deficiency (<10 ng/mL), on stable medication for at least one month, able to consent, and able to attend visits at the Lahore site.
Not a fit: Patients with mild or severe UC, Crohn's disease or other autoimmune disorders, recent vitamin D supplementation, known kidney or liver disease, pregnant or breastfeeding women, or those outside the 20–40 age range are unlikely to benefit from this specific protocol.
Why it matters
Potential benefit: If successful, adding vitamin D3 to usual treatment could reduce intestinal inflammation and improve symptoms and quality of life for adults with moderate ulcerative colitis who are vitamin D deficient.
How similar studies have performed: Prior observational studies and some interventional trials suggest vitamin D can affect inflammation in IBD, but randomized evidence is mixed and trials specifically in severely deficient moderate UC patients are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Lahore, Punjab Province
- University of Veterinary & Animal Sciences, Lahore — Lahore, Punjab Province, Pakistan (Recruiting)
Study contacts
- Principal investigator: Dr. Qaisar Raza, PhD — University of Veterinary & Animal Sciences, Lahore
- Study coordinator: Muhammad Barkaat Azam, PhD Scholar
- Email: barkaatazam@gmail.com
- Phone: 923336654554
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.