NCT04610827终止4 期
Optimum Frequency and Timing of Oral Iron Administration for Childhood Restless Leg Syndrome/Periodic Limb Movement Disorder
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Ferritin Level
研究概览
简要总结
The purpose of this research study is to see if the level of serum ferritin differs based on how often oral iron (in the form of ferrous sulfate) is given to children with restless leg syndrome/periodic limb movement disorder.
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
- None
入排标准
- 年龄范围
- 2 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ferritin equal to or lower than 24 mcg/L drawn within the last 30 days.
- •Age 2 to 10 years.
- •Diagnosis of restless leg syndrome, periodic limb movement disorder, or sleep disturbance.
排除标准
- •Currently taking oral formulation of iron other than a multivitamin.
- •Untreated obstructive sleep apnea.
- •Gastrointestinal disorder, including gastroesophageal reflux disease and celiac disease.
- •Prior gastrointestinal surgery; e.g., gastrectomy, duodenal bypass, and presence of G-tube.
- •Use of H2 blocker, antacid, or proton pump inhibitor.
- •Inflammatory disorders, including juvenile idiopathic arthritis or inflammatory bowel disease.
- •Elevated CRP at time of initial ferritin or report of illness in past 4 weeks.
研究组 & 干预措施
Ferrous sulfate daily
Active Comparator
Subject will take 3 mg/kg oral iron in the morning
干预措施: Ferrous sulfate (Drug)
Ferrous sulfate twice daily
Active Comparator
Subjects will take 1.5 mg/kg oral iron twice daily
干预措施: Ferrous sulfate (Drug)
Ferrous sulfate every other day
Active Comparator
6 mg/kg oral iron every other day in the morning
干预措施: Ferrous sulfate (Drug)
结局指标
主要结局
Ferritin Level
时间窗: 2 months
Ferritin level in blood measured in micrograms per liter
Side Effects
时间窗: 2 months
Number of subjects to experience side effects effects (e.g., stool color change, nausea, constipation, teeth staining)
次要结局
未报告次要终点
研究者
Julie M. Baughn
Principal Investigator
Mayo Clinic
研究点 (1)
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