Assessment of bone health and thyroid hormone function in children who are taking medications for epilepsy

Completed

• Conditions: Epilepsy, unspecified, Those who are on anti-epileptic drug for more than 1 year,

• Registration Number: CTRI/2019/01/017107
• Lead Sponsor: Bharati Vidyapeeth University Medical College Pune

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-30
• Study Completion: 2023-07-31
• Last Update Posted: 2023-09-18

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

On antiepileptic drug therapy for minimum period of 1 year.

Exclusion Criteria

• Children with cerebral palsy 2.
• Children not co-operative for DEXA scan-like mental subnormality 3.
• Children with contractures/orthopedic problems.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To estimate serum calcium,phosphorous, alkaline phosphatase, T4 and TSH levels	At enrolment
2. To estimate Bone mineral density using DEXA scan	At enrolment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Bharati hospital, Pune; 🇮🇳 Pune, MAHARASHTRA, India

Bharati hospital, Pune

🇮🇳Pune, MAHARASHTRA, India

Dr Kavita Srivastava

Principal investigator

9850825791

kavisri1970@gmail.com