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CTRI Number  CTRI/2024/09/073462 [Registered on: 05/09/2024] Trial Registered Prospectively
Last Modified On: 26/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Quality of life improvement with vitamin D supplementation in allergic rhinitis patients. 
Scientific Title of Study   Effect of vitamin D supplementation on quality of life of patients with perennial Allergic Rhinitis: A Randomized Controlled Trial.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arindam Malik 
Designation  Resident 
Affiliation  Geetanjali Medical College and Hospital 
Address  Department of ENT, Geetanjali Medical College and Hospital, Manwakhera NH-8 bypass, Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  9972668490  
Fax    
Email  arindammalik1@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Nitin Sharma 
Designation  Professor 
Affiliation  Geetanjali Medical College and Hospital 
Address  ENT OPD, J-Block, 1st floor, Geetanjali Hospital

Udaipur
RAJASTHAN
313001
India 
Phone  9610089189  
Fax    
Email  drnitinz@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Arindam Malik 
Designation  Resident 
Affiliation  Geetanjali Medical College and Hospital 
Address  Department of E.N.T., Geetanjali Medical College and Hospital, Manwakhera NH-8 Bypass, Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  9972668490  
Fax    
Email  arindammalik1@gmail.com  
 
Source of Monetary or Material Support  
Department of E.N.T., Geetanjali Medical College and Hospital, Manwakhera NH-8 Bypass, Udaipur 
 
Primary Sponsor  
Name  Geetanjali Medical College and Hospital 
Address  Geetanjali Medical College and Hospital, Hiranmagri Extension, Manwakhera NH-8 Bypass, Udaipur, Rajasthan 313001 
Type of Sponsor  Private medical college 
 
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 
Arindam Malik  Geetanjali Medical College and Hospital  E.N.T. OPD, Department of E.N.T.
Udaipur
RAJASTHAN 
9972668490

arindammalik1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Research Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J30||Vasomotor and allergic rhinitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Cholecalciferol   Cholecalciferol 60,000 IU once a week for 8 weeks  
Comparator Agent  Fluticasone Furoate   Fluticasone Furoate 27.5mcg 2 puff BD for 8 weeks  
Intervention  To evaluate the effect of vitamin D supplementation on quality of life of patients with perennial allergic rhinitis.  • To evaluate quality of life in perennial allergic rhinitis patients with vitamin D supplementation in terms of: - Total Nasal Symptom Score (TNSS) - Rhinitis Control Assessment Test score (RCAT) - Total eosinophil count (TEC) • To evaluate serum vitamin D levels in patients of perennial allergic rhinitis. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  i. Perennial Allergic Rhinitis patients with serum 25 (OH)-Vitamin-D3 levels less than 20 ng/ml.
ii. Patients who will give informed consent for participation in the study.
 
 
ExclusionCriteria 
Details  i. Associated Nasal co-morbidities like Nasal Polyposis, Sinusitis, Deviated Nasal Septum, Autoimmune disease of nose.
ii. Associated Systemic co-morbidities affecting vitamin D levels like Juvenile Idiopathic Arthritis, Rickets, Cystic Fibrosis, Ulcerative Colitis, Crohn’s disease, Celiac disease, Thyroid dysfunction.
iii. Individuals who had received medications including corticosteroids, barbiturates, bisphosphonates, omega-3 fatty acids, anti-epileptics and vitamin D.
iv. Pregnant and breastfeeding women.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in TEC levels, TNSS score and RCAT score with Vitamin D supplementation   Baseline(at 0 weeks), 4 weeks and 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Better understanding of the relation between serum vitamin D levels & symptom severity of perennial allergic rhinitis.  Baseline(at 0 weeks), 4 weeks & 8 weeks 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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   Phase 2 
Date of First Enrollment (India)   10/09/2024 
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="6"
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [arindammalik1@gmail.com].

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 01-04-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

Allergic rhinitis (AR) is the most common type of chronic rhinitis, affecting 10–25% of the population worldwide and in India its incidence is 20–30% 1, and evidence suggests that the prevalence of the disorder is increasing 2. Severe allergic rhinitis has been associated with significant impairments in quality of life (QOL), sleep and work performance. Despite the recent epidemiologic evidence that the incidence of allergic rhinitis is increasing worldwide, less than 12% of allergy sufferers seek medical recommendations from a physician, resulting in allergic rhinitis being frequently under recognized, misdiagnosed, and ineffectively treated 3, 4. It poses psychosocial and financial burden on society. Allergic rhinitis is typically manifested by patients having nasal congestion, rhinorrhoea, sneezing, and nasal itching as well as ocular redness, tearing, and itching. Nearly 50% of allergic rhinitis patients will experience symptoms for at least 4 months of the year. Allergic rhinitis, as a non-life threatening disease, has not been regarded as a serious health problem, despite the evidence suggesting it has important short-term and long-term health consequences 5. The economic burden is further enhanced as allergic rhinitis and asthma are often comorbid conditions. Approximately 85% of asthmatic patients have allergic rhinitis, whereas up to 40% of allergic rhinitis patients have or will develop asthma 6, 7. Treatment options consist of drugs like anti-histamines, intranasal corticosteroids, decongestants, and more recently immunotherapy. In recent years, there has been worldwide increase in allergic diseases more so in developed countries and this has been associated with low vitamin D. Current lifestyle has led to people spending more times indoors, leading to less sun exposure and less cutaneous vitamin D production. In present study efficacy of vitamin d supplementation and serum vitamin d levels will be evaluated in patients suffering from moderate to severe allergic rhinitis in both seasonal and perennial cases.

 

It is an immune (IgE) mediated inflammatory reaction of upper airway after allergen exposure. Despite of being treated there is lack of satisfaction among patients. Thus, it is necessary to focus on other causes and treatment modalities of allergic rhinitis. In current scenario, Vitamin D deficiency is increasingly contributed as a potential etiologic or disease-modifying factor in various allergic conditions including allergic rhinitis. The US National Health and Nutritional Examination Survey (NHANES) revealed that mean serum 25-hydroxyvitamin D (25(OH)D) decreased from 30 ng/ mL in 1988–1994 to 24 ng/mL in 2001–2004. National population surveys found that both vitamin D deficiency and allergic diseases are increasing year by year possibly due to increased westernization 8. Previous literatures revealed that Vitamin D plays an important role in decreasing sensitivity to allergens and its deficiency is associated with increased serum IgE levels. Limited literature is there which delineate relationship between serum vitamin D level and allergic rhinitis and its use as a therapeutic agent for its treatment. Several studies have investigated the role of vitamin D in the treatment of allergic diseases and asthma, however the results are still controversial 9, 10.

 
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