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CTRI Number  CTRI/2017/08/009232 [Registered on: 02/08/2017] Trial Registered Retrospectively
Last Modified On: 01/08/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Comparison of effect of oral nano vitamin D3 versus placebo to reduce disease activity in patients suffering from ulcerative colitis. 
Scientific Title of Study   A double blind randomized control trial to study the effect of oral 25-hydroxy vitamin D versus placebo in addition to standard therapy in patients with active ulcerative colitis on clinical/endoscopic response and markers of mucosal inflammation. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Usha Dutta 
Designation  Professor of Gastroenterology 
Affiliation  PostGraduate Institute of Medical Education and Research, Chandigarh 
Address  Department of Gastroenterology PGIMER Sector 12

Chandigarh
CHANDIGARH
160012
India 
Phone  8198877022  
Fax  0172-2744401  
Email  ushadutta@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Usha Dutta 
Designation  Professor of Gastroenterology 
Affiliation  PostGraduate Institute of Medical Education and Research, Chandigarh 
Address  Department of Gastroenterology PGIMER Sector 12

Chandigarh
CHANDIGARH
160012
India 
Phone  8198877022  
Fax  0172-2744401  
Email  ushadutta@gmail.com  
 
Details of Contact Person
Public Query  
Name  Rizwan Ahamed Z 
Designation  Doctor/(DM)senior resident in gastroenterology 
Affiliation  PostGraduate Institute of Medical Education and Research, Chandigarh 
Address  Department of Gastroenterology PGIMER Sector 12 Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  7087217776  
Fax    
Email  rizwiz87@gmail.com  
 
Source of Monetary or Material Support  
Postgraduate Institute of Medical Education and Research sector 12 Chandigarh 160012 
 
Primary Sponsor  
Name  PostGraduate Institute of Medical Education and Research 
Address  PGIMER,Chandigarh Sector 12 160012 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prof Usha Dutta  PGIMER, Chandigarh  Department Of Gastroenterology Level 1 F block Nehru hospital
Chandigarh
CHANDIGARH 		 8198877022

ushadutta@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
InstitutionalEthicsCommittee,PGIMER,CHANDIGARH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  patients suffering from active ulcerative colitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nano solution oral Vitamin D3  Nano preparation of oral vitamin D3. 5ml of this solution which contains 60,000 I.U.will be taken orally on empty stomach once daily for 8 days only. 
Comparator Agent  similar placebo  the placebo solution looks and tastes like the active drug. 5 ml of this solution once a day on an empty stomach orally for 8 days 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients suffering from active ulcerative colitis 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
i. Response is defined as reduction of at least 3 points in the disease activity index (UCDAI) from the baseline value at 4 weeks.
ii. Reduction in the stool frequency by 2/day
iii. Improvement in stool consistency (Bristol score) by 2 points
 		 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Remission
1. Remission is defined as achieving UCDAI score less than 3 at 4 weeks
2. Reduction of Fecal Calprotectin by 50 units
3. Reduction of endoscopic and histological markers of inflammation
4. Improvement in quality of life 		 4 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   04/01/2017 
Date of Study Completion (India) 30/06/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none as of now 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

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. 
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