CTRI

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CTRI Number

CTRI/2026/02/103074 [Registered on: 05/02/2026] Trial Registered Prospectively

Last Modified On:

28/01/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Other (Specify)

Study Design

Single Arm Study

Public Title of Study

Study on the role of Vitamin D in patients wit Inflammatory Bowel Disease

Scientific Title of Study

Investigating the Role of Vitamin D in INFLAMMATORY BOWEL DISEASE: Exploring the Pathophysiological Insights,Immunomodulatory and anti inflammatory effects in a tertiary health centre of Uttar Pradesh

Trial Acronym

Nil

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Anil Kumar
Designation	Associate Professor and Nodal Head
Affiliation	Baba Raghav Das Government Medical College
Address	Department of Pharmacology Baba Raghav Das Medical College 273013 Gorakhpur UTTAR PRADESH 273013 India
Phone	8303060884
Fax
Email	dranilk194@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Mohamed Fiyas Konnola
Designation	Junior Resident
Affiliation	BRD medical college
Address	Department of Pharmacology Baba Raghav Das Medical College 273013 Gorakhpur UTTAR PRADESH 273013 India
Phone	8089999846
Fax
Email	talk2fiyas@hotmail.co.uk

Details of Contact Person
Public Query

Name	Dr Mohamed Fiyas Konnola
Designation	Junior resident
Affiliation	BRD medical college
Address	Department of Pharmacology Baba Raghav Das Medical College 273013 Gorakhpur UTTAR PRADESH 273013 India
Phone	8089999846
Fax
Email	talk2fiyas@hotmail.co.uk

Source of Monetary or Material Support

NIL

Primary Sponsor

Name	Dr Mohamed Fiyas Konnola
Address	Department of Pharmacology,BRD Medical College,Gorakhpur,Uttar Pradesh,India 273013
Type of Sponsor	Other [Self]

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
Dr Mohamed Fiyas	Nehru hospital of Baba Raghav Das government medical college	Resident room,Department of pharmacology,Baba Raghav Das Government Medical College Gorakhpur UTTAR PRADESH	8089999846 talk2fiyas@hotmail.co.uk

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
INSTITUTIONAL HUMAN ETHICAL COMMITTEE Baba Raghav Das Medical College	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: K509\|\|Crohns disease, unspecified,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Nil	Nil
Intervention	Vitamin D	Vitamin D is given to all the participant patients having IBD and evaluated the vitamin D level periodically every 3 months up to 1 year of time

Inclusion Criteria

Age From	14.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	Patients diagnosed with Crohns disease or ulcerative colitis based on clinical, endoscopic histological or radiological findings Participants aged between 14 and 65 years regardless of disease activity who have been receiving treatment for at least six months Willingness to undergo serum vitamin D level assessment Patients with or without ongoing treatment for IBD Both active disease and remission phases can be included as per validated activity indices Written informed consent to participate in the study Willingness to comply with followup visits and further assessments as per study protocol

ExclusionCriteria

Details

Patients with chronic illnesses or autoimmune diseases unrelated to IBD
Current or recent use of high-dose vitamin D supplements or other medications affecting vitamin D metabolism
Patients with primary bone disorders like osteoporosis or osteomalacia not related to IBD.
Presence of significant liver disease, renal disease, or cardiovascular conditions that could confound results.
Pregnant or lactating women due to altered vitamin D metabolism.
Conditions unrelated to IBD that may cause malabsorption (e.g., celiac disease, short bowel syndrome).
Patients who have undergone major gastrointestinal surgery in the past 3 months.
Patients unable to comply with the study protocol, follow-up visits, or assessments.
History of alcohol or substance abuse that could interfere with study participation or data accuracy.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

An Open list of random numbers

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Impact of Vitamin D supplementation on IBD	Baseline,12 weeks,24 weeks

Secondary Outcome

Outcome	TimePoints
Adverse drug reaction of drugs	Every two weeks for six weeks

Target Sample Size

Total Sample Size="102"
Sample Size from India="102"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

N/A

Date of First Enrollment (India)

09/02/2026

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

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

Response - YES

What data in particular will be shared?
Response (Others) - De-identified aggregate data may be shared upon reasonable request after publication

What additional supporting information will be shared?
Response - None of the above
Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.

For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.

By what mechanism will data be made available?
Response (Others) - Data will be available by the principal investigator upon the reasonable request via email

For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Beginning 3 months and ending 5 years following article publication.

Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL

Brief Summary

A single arm,Open label interventional study to understant the levels of Vitamin D in IBD patients in a tertiary health center of Uttar Pradesh,To evaluate the immunomodulatory effects of Vitamin D in IBD patients,To analyze the anti-inflammatory effects of Vitamin D supplementation in IBD,To investigate the relationship between Vitamin D deficiency and the severity of IBD symptoms and To assess the role of Vitamin D in the clinical management and progression of IBD.