| CTRI Number |
CTRI/2019/01/017107 [Registered on: 16/01/2019] Trial Registered Prospectively |
| Last Modified On: |
18/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of bone health and thyroid hormone function in children who are taking medications for epilepsy |
|
Scientific Title of Study
|
Effect of prolonged anti-epileptic drug therapy on calcium profile, thyroid profile and bone mineral density in Indian children |
| Trial Acronym |
None |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kavita Srivastava |
| Designation |
Professor in Pediatrics |
| Affiliation |
Bharati Vidyapeeth Medical College, Pune |
| Address |
Department of pediatrics, 3rd floor, Bharati Hospital, Katraj, Pune.
Pune
MAHARASHTRA
411043
India |
| Phone |
020-24375541 |
| Fax |
020-24375541 |
| Email |
kavisri1970@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita Srivastava |
| Designation |
Professor in Pediatrics |
| Affiliation |
Bharati Vidyapeeth Medical College, Pune |
| Address |
Department of pediatrics, 3rd floor, Bharati Hospital, Katraj, Pune.
Pune
MAHARASHTRA
411043
India |
| Phone |
020-24375541 |
| Fax |
020-24375541 |
| Email |
kavisri1970@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavita Srivastava |
| Designation |
Professor in Pediatrics |
| Affiliation |
Bharati Vidyapeeth Medical College, Pune |
| Address |
Department of pediatrics, 3rd floor, Bharati Hospital, Katraj, Pune.
Pune
MAHARASHTRA
411043
India |
| Phone |
020-24375541 |
| Fax |
020-24375541 |
| Email |
kavisri1970@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Bharati Vidyapeeth University Medical College Pune |
| Address |
3rd floor, Bharati Hospital, Katraj-Dhankavadi campus, Pune |
| Type of Sponsor |
Private 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 Kavita Srivastava |
Bharati hospital, Pune |
Room No. 10, Pediatric OPD, Bharati hospital, Pune
Pune
MAHARASHTRA |
9850825791
020-24375541
kavisri1970@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth Deemed University Medical College, Pune Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G409||Epilepsy, unspecified, Those who are on anti-epileptic drug for more than 1 year, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. On antiepileptic drug therapy for minimum period of 1 year |
|
| ExclusionCriteria |
| Details |
1. Children with cerebral palsy
2. Children not co-operative for DEXA scan-like mental subnormality
3. Children with contractures/orthopedic problems |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To estimate serum calcium,phosphorous, alkaline phosphatase, T4 and TSH levels
2. To estimate Bone mineral density using DEXA scan |
At enrolment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To correlate parameters of bone health and thyroid profile with number, type and duration of anti-epileptic drugs
2. To compare the same in healthy controls who are not on anti-epileptic drug therapy |
At enrolment |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/01/2019 |
| Date of Study Completion (India) |
31/07/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Children between the age of 5 to 18 years, who are on anti-epileptic drug/s will be recruited into the study. Anthropometry, puberty signs, nutritional intake, physical activity, vitamin supplementation and sunlight exposure etc. will be recorded on the case record form. Their blood samples will be taken and serum calcium, phosphorus, Alkaline phosphatase, T4 and TSH will be estimated. They will be subjected to DEXA scan to measure the bone mineral density (BMD). The healthy controls will be mostly siblings in the same age group whose serum and BMD values will be taken for comparison. The outcomes will be compared in both the groups and the effect of duration of therapy, type of drug used, physical activity and sunlight exposure etc. will be studied.
|