Effect of prolonged anti-epileptic drug therapy on calcium profile, thyroid profile and bone mineral density in Indian children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 1. To estimate serum calcium,phosphorous, alkaline phosphatase, T4 and TSH levels
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 5.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •On antiepileptic drug therapy for minimum period of 1 year.
排除标准
- •Children with cerebral palsy
- •Children not co-operative for DEXA scan-like mental subnormality
- •Children with contractures/orthopedic problems.
结局指标
主要结局
1. To estimate serum calcium,phosphorous, alkaline phosphatase, T4 and TSH levels
时间窗: At enrolment
2. To estimate Bone mineral density using DEXA scan
时间窗: At enrolment
次要结局
- 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)