Effect of Thiamin Supplementation on Thiamin Status in Children With Heart Disease Receiving Diuretic Drugs: Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in thiamin pyrophosphate effect
研究概览
简要总结
The purpose of this study is to determine effect of thiamin supplementation on thiamin status by measuring thiamin pyrophosphate effect in children with heart disease receiving diuretic drugs.
详细描述
Children with heart disease receiving diuretic drugs are susceptible to thiamin deficiency due to increase renal loss. Thiamin deficiency causes abnormal cardiac contraction resulting in heart failure.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 1 month old to 15 years old diagnosed as heart disease
- •Receiving diuretic drugs at least 1 month
排除标准
- •Receiving thiamin-containing vitamins
- •Receiving hemodialysis or peritoneal dialysis
- •Having problems of intestinal malabsorption, chronic lung disease, red blood cell abnormality such as thalassemia , abnormal hemoglobin typing, G6PD deficiency
- •Receiving thiamin-producing probiotics
- •Receiving inotropic drugs
- •Severe anemia: Hb < 7 g/dL
研究组 & 干预措施
Low dose
Low dose of thiamin supplementation
干预措施: Thiamine Mononitrate (Drug)
High dose
High dose of thiamin supplementation
干预措施: Thiamine Mononitrate (Drug)
Placebo
placebo supplementation
干预措施: Thiamine Mononitrate (Drug)
结局指标
主要结局
Change in thiamin pyrophosphate effect
时间窗: 4 weeks
Compare percentage change in thiamin pyrophosphate effect before and after thiamin supplementation
次要结局
未报告次要终点
研究者
Narumon Densupsoontorn
Associate Professor
Mahidol University