NCT00781196已完成3 期
Effect of Low Dose Oral Folic Acid Supplementation on Phenytoin Induced Gingival Overgrowth: A Randomized Double Blind Controlled Trial.
All India Institute of Medical Sciences, New Delhi1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2008年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Occurrence of any grade of overgrowth in 2 groups after 6 mo of phenytoin therapy
研究概览
简要总结
Phenytoin, a common anti-seizure drug, leads to cosmetically unacceptable side effect of gingival overgrowth in a significant number of patients. There is some evidence of therapeutic effect of folic acid in cases of established phenytoin induced gingival overgrowth. In this study, the aim is to study the prospective preventive effect of low dose oral folic acid supplementation on phenytoin induced gingival overgrowth in epileptic children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 6-15 yr
- •Started on phenytoin within 1 mo of enrollment
排除标准
- •Not willing to participate
- •On other folic acid antagonists e.g. anti-neoplastic drugs for >/= 2 wks during last 3 months
- •Pre-existing gingival over-growth due to other cause
研究组 & 干预措施
1
Experimental
Oral folic acid
干预措施: folic acid (Drug)
2
Placebo Comparator
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Occurrence of any grade of overgrowth in 2 groups after 6 mo of phenytoin therapy
时间窗: 6 months
次要结局
- Occurrence of grade > 2 hyperplasia at the end of 6 mo(6 months)
- Time to occurrence of grade > 2 overgrowth(open)
- Correlation between following and occurrence of grade > 2 overgrowth *phenytoin dose (in mg/kg/d) *serum phenytoin levels *plaque index(6 months)
研究者
研究点 (1)
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