| CTRI Number |
CTRI/2015/06/005844 [Registered on: 02/06/2015] Trial Registered Retrospectively |
| Last Modified On: |
04/02/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Vitamin D in Childhood Asthma |
|
Scientific Title of Study
|
Prospective controlled trial to evaluate the effect of vitamin D supplementation on asthma control in children
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof S K Kabra |
| Designation |
Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Division of Pulmonology and Intensive Care
Department of Pediatrics
AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
skkabra@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof S K Kabra |
| Designation |
Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Division of Pulmonology Intensive Care
Department of Pediatrics
AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
skkabra@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof S K Kabra |
| Designation |
Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Division of Pulmonology Intensive Care
Department of Pediatrics
AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
skkabra@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Council of scientific Industrial Research |
|
|
Primary Sponsor
|
| Name |
Council of scientific Industrial Research |
| Address |
Opp. Intitute of Hotel Management
Library Avenue, Pusa, New Delhi-12 |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Prof SK Kabra |
AIIMS, NEW DELHI |
Room No.3067
Department Of Pediatrics
AIIMS, New Delhi, India
South
DELHI |
01126594610
skkabra@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstituteEthicsCommittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
asthmatic children , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicabe |
Not applicabe |
| Intervention |
Vitamin D |
vitamin D along with calcium supplement will be given only to those children found to have Vitamin D deficiency.
Oral Vitamin D 60000/day BD for 5 days followed by maintenance dose of 400-800 IU/day for 6 months . Calcium supplentation also done in a dose of 30-70mg/kg/day peroral. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Age- Criteria: 5-16yrs
Intermittent Cough
Breathlessness
Recurrent Wheezing present
Response to bronchodilator present
|
|
| ExclusionCriteria |
| Details |
1.interstitial lung disease
2.congenital heart disease
3. tuberculosis / Cystic fibrosis / HIV infection
4.Bronchomalacia / Laryngomalacia
6.Tracheo-esophageal fistula
7.Medications inducing chronic cough (ACEI)
8.Chronic liver / renal disease
9.Residing outside Delhi or unlikely to come for follow up
10.Frank vitamin D deficiency viz.Harrison’s sulcus?
11.Patient have any chest wall deformity
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of vitamin D supplementation, on FEV1 in asthmatic children with vitamin D deficiency. |
To evaluate the effect of vitamin D supplementation, on FEV1 in asthmatic children with vitamin D deficiency.
FEV1 will be monitored at 3months & 6months follow up period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
i)To compare the following parameters (pre and post intervention ) asthmatic children with vitamin D deficiency on :
1.Change in quality of life after vitamin D supplementation.
2. Number of acute exacerbations
3. Hospital emergency visits
4. Number of hospitalisation
ii)To study the trend of FEV1 in children without vitamin d deficiency.
|
3 & 6 months post intervention |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
19/09/2013 |
| 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) |
Open to Recruitment |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
With growing economy, we spend more time indoors exacerbating the problem of vitamin D deficiency. The prevalence of both asthma, the most common chronic illness in children and vitamin D deficiency have dramatically increased in recent years, suggesting they may be linked and a causal relationship. Vitamin D serves many biological actions apart from its bone maintenance effect. Of relevance to asthma, vitamin D has effects on the immune system and on lung development and function . Preliminary epidemiologic studies hint at a possible role of vitamin D in asthma development and in decreasing exacerbations. However, because of potential confounding factors, well-designed clinical trials are needed to establish this causal relationship. There are paucity of prospective studies that have studied the effect of vitamin D supplementation on asthma control, pulmonary function tests and quality of life score. Given the above background, it would be rational to evaluate the effect of vitamin D supplementation in vitamin D deficient asthmatic children.With growing economy, we spend more time indoors exacerbating the problem of vitamin D deficiency. The prevalence of both asthma, the most common chronic illness in children and vitamin D deficiency have dramatically increased in recent years, suggesting they may be linked and a causal relationship. Vitamin D serves many biological actions apart from its bone maintenance effect. Of relevance to asthma, vitamin D has effects on the immune system and on lung development and function . Preliminary epidemiologic studies hint at a possible role of vitamin D in asthma development and in decreasing exacerbations. However, because of potential confounding factors, well-designed clinical trials are needed to establish this causal relationship. There are paucity of prospective studies that have studied the effect of vitamin D supplementation on asthma control, pulmonary function tests and quality of life score. Given the above background, it would be rational to evaluate the effect of vitamin D supplementation in vitamin D deficient asthmatic children.
|