| CTRI Number |
CTRI/2017/10/010274 [Registered on: 31/10/2017] Trial Registered Prospectively |
| Last Modified On: |
28/10/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Vitamin D3 intake and decrease in Respiratory infections. |
|
Scientific Title of Study
|
Randomised Trial of Two Different Doses of Vitamin D Supplementation And Risk of Acute Respiratory Infection in Childrens in Rural Kolar, Karnataka. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kanak N Venkateshwara Prasad |
| Designation |
Professor |
| Affiliation |
Sri Devraj Urs Medical College |
| Address |
Department of Pediatrics, Sri Devraj Urs Medical College, SDUAHER,Tamaka, Kolar, Karnataka.
Kolar KARNATAKA 563101 India |
| Phone |
9740551490 |
| Fax |
|
| Email |
drknvp@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Kanak N Venkateshwara Prasad |
| Designation |
Professor |
| Affiliation |
Sri Devraj Urs Medical College |
| Address |
Department of Pediatrics, Sri Devraj Urs Medical College, SDUAHER,Tamaka, Kolar, Karnataka.
Kolar KARNATAKA 563101 India |
| Phone |
9740551490 |
| Fax |
|
| Email |
drknvp@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Kanak N Venkateshwara Prasad |
| Designation |
Professor |
| Affiliation |
Sri Devraj Urs Medical College |
| Address |
Department of Pediatrics, Sri Devraj Urs Medical College, SDUAHER,Tamaka, Kolar, Karnataka.
Kolar KARNATAKA 563101 India |
| Phone |
9740551490 |
| Fax |
|
| Email |
drknvp@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Devaraj Urs Academy of Higher Education and Research, Tamaka(Pin 563103), Kolar, karnataka, India |
|
|
Primary Sponsor
|
| Name |
Sri Devaraj Urs Academy of Higher Education and Research |
| Address |
Sri Devaraj Urs Academy of Higher Education and Research, Tamaka, Kolar |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Kanak N Venkateshwara Prasad |
Sri Devaraj Urs Medical College |
Department of Pediatrics, Sri Devraj Urs Medical College, SDUAHER,Tamaka, Kolar, Karnataka. Kolar KARNATAKA |
9740551490
drknvp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central ethics Committee of Sri Devaraj Urs Academy of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
3 years to 6 years age grouped healthy childrens are participated without Vitamin D deficiency |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Large Vitamin D3 supplimentary dose |
Dose-3000IU, Every Day Once for 3 Months, same Dose and Frequency for another 3 months after a Intervention free period of 6 Months |
| Comparator Agent |
Normal Vitamin D3 supplimentary dose |
Dose-600IU, Every Day Once for 3 Months, same Dose and Frequency for another 3 months after a Drug free period of 6 Months |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Healthy children by parental report. Age group of completed 3 years – 6th year running.
Present to RL Jallappaschool in Kolar. Parents provide informed consent to participate
|
|
| ExclusionCriteria |
| Details |
Children with chronic illness (except for asthma) on parental report which is known to interfere with vitamin D metabolism and increase the risk of respiratory infection. Child having clinical rickets. Child already on vitamin supplementation
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of Parent reported and Class teacher detected acute respiratory tract infections |
upto 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Serum vitamin D levels. |
Serum vitamin D levels at the time of Recuriment and at the end of each 3 Months of Vitamin D3 supplimentation. |
|
|
Target Sample Size
|
Total Sample Size="170" Sample Size from India="170"
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)
|
12/01/2018 |
| 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
|
1.AUTHORS: YC Manjunatha, KNV Prasad, YC Beeregowda, A
Bhaskaran
TITLE: Multiple Splenic Artery Aneurysms Secondary to
Extra Hepatic Portal Vein Obstruction
JOURNAL: J ClinDiagn Res.
YEAR: 2013.
2. KNV Prasad, A Rajha, PK Vegi.
A Case of Monozygotic Twins: The Value of Discordant Monozygotic Twins in Goldenhar Syndrome—OMIM%164210.
Case reports in pediatrics Hindawi Publishing Corporation.
2013.
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Vitamin D is known to be of physiological importance outside of bone health and calcium homeostasis, and there is mounting evidence that it plays a beneficial role in the prevention and/or treatment of a wide range of diseases. Vitamin D appears capable of inhibiting pulmonary inflammatory responses while enhancing innate defence mechanisms against respiratory pathogens. Epidemiological studies have shown that low serum 25-hydroxyvitamin D levels are associated with a higher risk of upper and lower respiratory infections in children. This knowledge is particularly relevant and timely, because infants and children appear more susceptible to viral rather than bacterial infections in the face of vitamin D deficiency. The connection between vitamin D, infections and immune function in the paediatric population indicates a possible role for vitamin D supplementation in potential interventions and adjuvant therapies. The ideal amount of vitamin D intake needed to prevent the adverse health conditions associated with vitamin D insufficiency/deficiency remains unclear. Disagreements on cut-off values for vitamin D sufficiency in the pediatric population likewise complicate interpretation of the recommendations. Furthermore, recommendations for increased sunlight exposure to promote adequate cutaneous vitamin D3 synthesis will need to be balanced with concerns for the risks associated with the increased time spent in the sun exposed to UV radiation. Based on currently available research, however, support for supplementation greater than what prevents the most adverse outcomes (i.e. Severe rickets) is strongly advocated. Population-based studies showing an association between circulating vitamin D levels and lung function provide strong justification for randomized controlled clinical trials of vitamin D supplementation in patients with respiratory diseases to assess both efficacy and optimal dosage. |