| CTRI Number |
CTRI/2022/11/047299 [Registered on: 15/11/2022] Trial Registered Prospectively |
| Last Modified On: |
02/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
To Study the role of vitamin D in asthma |
|
Scientific Title of Study
|
EFFECT OF VITAMIN D ON ASTHMA CONTROL AND QUALITY OF LIFE IN PATIENTS OF MODERATE BRONCHIAL ASTHMA WITH VITAMIN D DEFICIENCY: A PROSPECTIVE STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vandana Tayal |
| Designation |
Professor |
| Affiliation |
Maulana azad medical college |
| Address |
Room no. 104, Department of pharmacology, Maulana azad medical college, New Delhi
Central
DELHI
110002
India |
| Phone |
|
| Fax |
|
| Email |
vandana_tayal@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Puneet |
| Designation |
PG 1 |
| Affiliation |
Maulana azad medical college |
| Address |
Room no. 162, Department of pharmacology, Maulana azad medical college, New Delhi
Central
DELHI
110002
India |
| Phone |
|
| Fax |
|
| Email |
puneetgoel96@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Puneet |
| Designation |
PG 1 |
| Affiliation |
Maulana azad medical college |
| Address |
Room no. 162, Department of pharmacology, Maulana azad medical college, New Delhi
Central
DELHI
110002
India |
| Phone |
|
| Fax |
|
| Email |
puneetgoel96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana azad medical college and associated Lok Nayak Hospital |
|
|
Primary Sponsor
|
| Name |
Maulana azad medical college and associated Lok Nayak Hospital |
| Address |
Bahadurshah zafar marg, New Delhi - 110002 |
| 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 |
| Puneet |
Maulana Azad medical college and associated hospitals |
Room no. 162, Department of Pharmacology
Central
DELHI |
9136621864
puneetgoel96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J454||Moderate persistent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Vitamin D |
Vitamin D 60,000 IU per week in sachet form for Vitamin D deficient patients (in asthmatics) for 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with moderate asthma diagnosed according to latest GINA guidelines [2022] for at least 1 month |
|
| ExclusionCriteria |
| Details |
1.History of any chronic disease other than asthma (like cancer, liver disease, gall bladder disease, diabetes, uncontrolled hypertension and GI disorders affecting vitamin D absorption).
2.Respiratory tract infection within past 4 weeks.
3.Known allergy to vitamin D or taking vitamin D supplements.
4.Hypercalcemia (>11mg/dl) or taking calcium supplements or history of recurrent kidney stones, Hyperparathyroidism (>65pg/ml) and deranged serum electrolytes.
5.Use of concomitant medications that alter vitamin D metabolism (e.g phenytoin, corticosteroids) or absorption (e.g cholestyramine) or those that interfere with study endpoints.
6.History of cigarette smoking (more than 10 packs a year).
7.Deranged LFT (Liver enzymes >3 times upper limit of normal) or KFT (serum creatinine >1.2mg/dl)
8.Pregnant and nursing mothers
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Asthma control test scores (ACT).
2)Frequency of asthma exacerbation.
|
0, 6weeks, 12weeks, 18weeks, 20weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Predictive percentage of forced expiratory volume in 1st second (FeV1), FEV1/FVC.
2)Serum eosinophils levels.
3)Quality of life (AQLQ- Asthma quality of life questionnaire).
4)Percentage of patients requiring change in asthma treatment (step up / step down).
5)No. of emergency visits and hospitalizations for asthma.
6)Adverse events.
|
0, 6weeks, 12weeks, 18weeks, 20weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/11/2022 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Bronchial asthma is one of the common chronic inflammatory diseases
affecting around 300 million people worldwide. Chronic nature of the disease and regular use of medications significantly
hampers the quality of life. Vitamin D deficiency prevails in epidemic proportions all over the
Indian subcontinent, with a prevalence of 70%–100% in the general population. Prevalence of vitamin D deficiency among
asthmatic patients has been found to be very high at 77.3%. Evidence suggests that vitamin D
plays a vital role in modulating the immune response and has
anti-inflammatory effect. Hence in the present study, we plan to determine the effect of vitamin D
supplementation on asthma control in patients with moderate asthma having vitamin
D deficiency and its effect on their quality of life
|