Comparison of effect of oral nano vitamin D3 versus placebo to reduce disease activity in patients suffering from ulcerative colitis.

Phase 3

Completed

• Conditions: patients suffering from active ulcerative colitis

• Registration Number: CTRI/2017/08/009232
• Lead Sponsor: PostGraduate Institute of Medical Education and Research

Brief Summary

This is a double blind randomized controlled trial aimed to study the effect of nano dose vitamin  D3 in patients suffering from active ulcerative colitis. Patients of ulcerative colitis presenting to our OPD with active disease will be screened for vitamin D deficiency and patients with vit D levels <40 ng/ml will be randomized into a drug arm and a placebo arm. Patients in the drug arm will be given 60000 I.U. of nano preparation of oral vitamin D once a day for 8 days and those in the placebo arm will be given 5 ml of similar looking placebo. Detailed history, clinical examination and investigations will be performed in all patients. Both serum and fecal markers of inflammation including ESR, CRP  and fecal calprotectin will be measured both at start and at 4 weeks. Endoscopy with biopsy, histopathological examination and scoring of disease severity will be done at the start of the study and at 4 weeks. we aim to study the effect of high dose vitamin D in reducing disease activity in patients of ulcerative colitis.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2017-01-08
• Study Start: 2017-04-01
• Study Completion: 2017-06-30

Recruitment & Eligibility

• Status: Completed
• Sex: All
• 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.
• 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.	4 weeks
ii.Reduction in the stool frequency by 2/day	4 weeks
iii.Improvement in stool consistency (Bristol score) by 2 points	4 weeks

Secondary Outcome Measures

Name	Time	Method
Remission	1. Remission is defined as achieving UCDAI score less than 3 at 4 weeks

Trial Locations

Locations (1)

PGIMER, Chandigarh; 🇮🇳 Chandigarh, CHANDIGARH, India

PGIMER, Chandigarh

🇮🇳Chandigarh, CHANDIGARH, India

Prof Usha Dutta

Principal investigator

8198877022

ushadutta@gmail.com