EFFECT OF THREE DIFFERENT DOSES OF ORAL CHOLECALCIFEROL (1000 IU, 3000 IU AND 6000 IU DAILY) ON SERUM 25-HYDROXYVITAMIN D CHANGES AMONG EPILEPSY PATIENTS WITH HYPOVITAMINOSIS D: A RANDOMIZED PROSPECTIVE STUDY
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 210
- 主要终点
- serum 25-hydroxyvitamin D changes in patients who received enzyme-inducing antiepileptic drugs (EIAEDs) versus patients receiving non enzyme-inducing antiepileptic drugs (non-EIAEDs) at the same dosage of cholecalciferal
研究概览
简要总结
To characterize the effect of three different doses of vitamin D3 supplementation on serum 25-hydroxyvitamin D (25(OH)D) changes in epilepsy patients receiving enzyme-inducing antiepileptic drugs (EIAEDs) versus patients receiving non enzyme-inducing antiepileptic drugs (non-EIAEDs), and to determine the prevalence of and risk factors for hypovitaminosis D among Thai patients with epilepsy.
详细描述
A single-blinded prospective, randomized study undertaken at epilepsy clinic of King Chulalongkorn Memorial Hospital. The patients with hypovitaminosis D were included and divided into two groups according to the type of AEDs use. Patients receiving each AEDs type were randomly assigned to receive vitamin D3 1000, 3000 or 6000 IU once daily. The mean increment in serum 25(OH)D levels were measured at 8 and 16 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Epilepsy patients, age ≥ 15 years, BMI18 - 30 kg/m2
- •Being treated with either enzyme inducing antiepileptic drugs (EIAEDs: phenytoin, phenobarbital, carbamazepine and topiramate) or non-enzyme inducing antiepileptic drugs (Non-EIAEDs: sodium valproate, levetiracetam, and lamotrigine) at a stable dosage regimen for at least a year.
- •Serum 25(OH)D <30ng/ml
排除标准
- •Patients with a history of hypercalcemia, nephrolithiasis, fractures, hepatic disease, kidney disease, granulomatous disease or currently supplemented with vitamin D.
研究组 & 干预措施
EIAEDs-1000
Patients receiving EIAEDs who were randomly assigned to receive vitamin D3 1000 IU once daily
干预措施: Cholecalciferol (Drug)
EIAEDs-3000
Patients receiving EIAEDs who were randomly assigned to receive vitamin D3 3000 IU once daily
干预措施: Cholecalciferol (Drug)
EIAEDs-6000
Patients receiving EIAEDs who were randomly assigned to receive vitamin D3 6000 IU once daily
干预措施: Cholecalciferol (Drug)
non-EIAEDs-1000
Patients receiving non-EIAEDs who were randomly assigned to receive vitamin D3 1000 IU once daily
干预措施: Cholecalciferol (Drug)
non-EIAEDs-3000
Patients receiving non-EIAEDs who were randomly assigned to receive vitamin D3 3000 IU once daily
干预措施: Cholecalciferol (Drug)
non-EIAEDs-6000
Patients receiving non-EIAEDs who were randomly assigned to receive vitamin D3 6000 IU once daily
干预措施: Cholecalciferol (Drug)
结局指标
主要结局
serum 25-hydroxyvitamin D changes in patients who received enzyme-inducing antiepileptic drugs (EIAEDs) versus patients receiving non enzyme-inducing antiepileptic drugs (non-EIAEDs) at the same dosage of cholecalciferal
时间窗: 8 and 16 months
次要结局
- Number (percentage) of the patients who have serum 25-hydroxyvitamin D levels more than 30ng/ml(16 months)