| CTRI Number |
CTRI/2025/08/093525 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Vitamin D Supplementation In Allergic Rhinitis |
|
Scientific Title of Study
|
Efficacy of Vitamin D Supplementation In Allergic Rhinitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hardik Jashvantbhai Patel |
| Designation |
Resident Doctor ( MS ENT ) |
| Affiliation |
Gmers Medical College And Hospital Gotri, Vadodara |
| Address |
2nd Floor Department of ENT, Gmers Medical College And Hospital,Gotri,Vadodara
Gmers Medical College AND Hospital Gotri, Vadodara
Vadodara
GUJARAT
390021
India |
| Phone |
7990018859 |
| Fax |
|
| Email |
drhjp4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishala Pandya |
| Designation |
Professor And Dean ( MS ENT ) |
| Affiliation |
Gmers Medical College And Hospital Gotri, Vadodara |
| Address |
2nd Floor Department of ENT, Gmers Medical college and Hospital,Gotri,Vadodara
Gmers Medical College And Hospital Gotri, Vadodara
Vadodara
GUJARAT
390021
India |
| Phone |
9824040485 |
| Fax |
|
| Email |
vishala_pandya@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hardik Patel |
| Designation |
Resident Doctor ( MS ENT ) |
| Affiliation |
Gmers Medical College And Hospital Gotri , Vadodara |
| Address |
2nd Floor Department of ENT, Gmers Medical college and Hospital,Gotri,Vadodara
Gmers Medical College And Hospital Gotri , Vadodara
Vadodara
GUJARAT
390021
India |
| Phone |
9824040485 |
| Fax |
|
| Email |
drhjp4@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gmers Medical College And Hospital Gotri, Vadodara
Gujarat
390021
|
|
|
Primary Sponsor
|
| Name |
Gmers Medical College And Hospital Gotri Vadodara |
| Address |
Gmers Medical College And Hospital Gotri Vadodara Gujarat
390021 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Hardik Patel |
GMERS medical College And Hospital Gotri Vadodara |
2nd floor Department of ENT
Old TB Campus Gotri Main Road, Gotri, VADODARA
Vadodara
GUJARAT |
7990018859
drhjp4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IHEC GMERS medical college and hospital,gotri |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R798||Other specified abnormal findingsof blood chemistry, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
vitamin d supplementation in allergic rhinitis |
all patients underwent a total nasal symptom score assessement before treatment. vitamine d supplementation will be administered to all participants and serum vitamin d3 level measurement will be done. patients with low vitamin d levels continued to receive vitamin d supplementation along with steroidal nasal spray and antihistamines.however patients with normal vitamin d levels will be discontinued vitamin d supplementation and will receive only steroidal nasal sprays and antihistamines |
| Intervention |
vitamin D3 supplementation in allergic rhinitis |
all patients underwent a total nasal symptom score assessement before treatment. vitamine d supplementation will be administered to all participants and serum vitamin d3 level measurement will be done. patients with low vitamin d levels continued to receive vitamin d supplementation along with steroidal nasal spray and antihistamines.however patients with normal vitamin d levels will be discontinued vitamin d supplementation and will receive only steroidal nasal sprays and antihistamines.This study will be conducted in the span of 1 year |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Total nasal symptom score four or more than four |
|
| ExclusionCriteria |
| Details |
1.patients who are cases of rhinitis apart from allergic causes.
2.associated comorbidities affecting vitamin d levels
3.individuals who had received medications including barbiturates,omega 3,and vitamin d |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| symptoms improvement after vitamin d supplementation in allergic rhinitis patient after 4 weeks |
symptoms improvement after vitamin d supplementation in allergic rhinitis patient after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| vitamin D level association with allergic rhinitis |
After 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
03/09/2025 |
| 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 Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
Group A patients with low vitamin D levels will be on Fluticasone 50mcg nasal spray 2 puffs BD for 4 weeks, Anti histamines and oral vitamin D 60000IU once a week for 4 weeks and Group B patients with normal vitamin D levels will be on Fluticasone 50mcg nasal spray 2 puffs BD and Antihistamines.
Post treatment TNSS score will be recorded in both groups after a period 4 weeks and results will be compared with Pre treatment score.
|