Assessment of malnutrition in patients with ulcerative colitis and effect of supplementation of Calcitriol in patients with active disease.
Phase 3
- Conditions
- Health Condition 1: K519- Ulcerative colitis, unspecified
- Registration Number
- CTRI/2021/03/031675
- Lead Sponsor
- Post Graduate Institute of Medical education and Research Chandigarh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Clinically diagnosed case of Ulcerative Colitis
Clinical indication for standard colonoscopy/sigmoidoscopy
Exclusion Criteria
•Unable to provide informed consent
Serious life-threatening co-morbidities
Pregnant and breastfeeding women
Patients with malignancy, serious life-threatening illnesses, renal or hepatic failure
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in Mayo score from baseline at 4 weeksTimepoint: 4 weeks <br/ ><br>
- Secondary Outcome Measures
Name Time Method i.â?¥ 3 point or â?¥ 30% Reduction in Mayo score from baseline at 4 weeks <br/ ><br>ii.â?¥ 2 Reduction in partial Mayo score at 2 weeks and 4 weeks. <br/ ><br>iii.Reduction from baseline in fecal calprotectin at 2 and 4 weeks <br/ ><br>iv.Reduction from baseline in CRP at 2 and 4 weeks <br/ ><br>v.Improvement in SIBDQ score at 4 weeks <br/ ><br>vi.Reduction from baseline in Robarts histopathological index (RHI) at 4 weeks <br/ ><br>vii.Failure of standard treatment requiring upgradation to steroids <br/ ><br>Timepoint: 4 weeks