Comparison of effect of oral nano vitamin D3 versus placebo to reduce disease activity in patients suffering from ulcerative colitis.
Phase 3
Completed
- Conditions
- Health Condition 1: null- patients suffering from active ulcerative colitis
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
Patients suffering from active ulcerative colitis
Exclusion Criteria
1.Inability to obtain written informed consent
2.Pregnant or lactating women
3.Patients with life threatening, cardiac, renal or pulmonary disease.
4.Severe disease requiring hospitalization.
5. Patients already supplemented with vitamin D
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method i.Response is defined as reduction of at least 3 points in the disease activity index (UCDAI) from the baseline value at 4 weeks. <br/ ><br>ii.Reduction in the stool frequency by 2/day <br/ ><br>iii.Improvement in stool consistency (Bristol score) by 2 points <br/ ><br>Timepoint: 4 weeks
- Secondary Outcome Measures
Name Time Method Remission <br/ ><br>1. Remission is defined as achieving UCDAI score less than 3 at 4 weeks <br/ ><br>2. Reduction of Fecal Calprotectin by 50 units <br/ ><br>3. Reduction of endoscopic and histological markers of inflammation <br/ ><br>4. Improvement in quality of lifeTimepoint: 4 weeks