Sucrosomial Iron on Insomnia in Non-dialysis Chronic Kidney Disease Patients With Iron Deficiency Anemia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Insomnia Severity Index (ISI)
研究概览
简要总结
Insomnia or sleep disturbance is a common disorder in patients with chronic kidney disease (CKD), but is often unrecognized and undertreated. It is known that sleep disorders may indirectly cause a variety of diseases and affect quality of life. The most common sleep disorders that occur in CKD are insomnia, excessive daytime sleepiness, obstructive or central sleep apnea (SA), and sleep disorders. This study evaluates the effectiveness and safety of Sideral® Sucrosomial Iron and iron chewable tablets 100mg commonly used in health insurance on sleep disorders in patients with CKD and iron deficiency anemia.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 20-
- •Chronic kidney disease (CKD) patients.
- •Iron deficiency anemia (male haemoglobin (Hb) ≤13 g/dL; female haemoglobin (Hb) ≤12 g/dL, ferritin ≤100 ng/mL, transferrin saturation ≤25%).
- •Patients diagnosed as chronic insomnia by doctors according to international classification of sleep disorders-third edition (ICSD-3).
- •Subjects who voluntarily participate in the trial plan and complete the consent form after explanation by doctors or project personnel.
排除标准
- •Patients taking iron supplements.
- •Patients with non-chronic insomnia.
- •Patients with alcoholism within one year.
- •People with other serious diseases.
- •Pregnant women or women who are still breastfeeding.
- •Those who are unable to cooperate with the test progress.
- •Patients with autoimmune abnormalities (ex. inflammatory bowel disease).
- •People with non-iron deficiency anemia (ex. thalassemia).
- •Those who are taking sleeping pills or sedatives.
研究组 & 干预措施
Sideral® Sucrosomial Iron
The study subjects continued to take Sucrosomial Iron 30mg supplements every day, 2 capsules a day, one 30 minutes after breakfast and dinner, for 12 consecutive weeks. During the study period, none of them used erythropoiesis stimulating agent (ESA).
干预措施: Sideral® Sucrosomial Iron (Dietary Supplement)
Placebo
The study subjects continued to take Iron chewable tablet 100mg supplements every day, 2 capsules a day, one 30 minutes after breakfast and dinner, for 12 consecutive weeks. During the study period, none of them used erythropoiesis stimulating agent (ESA).
干预措施: Iron chewable tablet (Dietary Supplement)
结局指标
主要结局
Insomnia Severity Index (ISI)
时间窗: week 0, 12
A sleep-related questionnaire, ranging from 0 to 28, where higher scores indicate more acute symptoms of insomnia.
Hemoglobin
时间窗: week 0, 12
Concentration of serum hemoglobin
Ferritin
时间窗: week 0, 12
Concentration of serum ferritin
Serum Iron
时间窗: week 0, 12
Concentration of serum Iron
Pittsburgh Sleep Quality Index (PSQI)
时间窗: week 0, 12
A sleep-related questionnaire, ranging from 0 to 21 with the higher total score indicating worse sleep quality.
Epworth sleepiness Scale (ESS)
时间窗: week 0, 12
A sleep-related questionnaire, ranging from 0 to 24. Scores from 0 to 10 reflect normal levels of daytime sleepiness, and scores over 10 are considered to reflect excessive daytime sleepiness.
Transferrin Saturation
时间窗: week 0, 12
Concentration of serum transferrin Saturation
Erythrocyte sedimentation rate
时间窗: week 0, 12
Concentration of serum erythrocyte sedimentation rate
次要结局
未报告次要终点
研究者
Chun-pai Yang, MD
Chief, Department of Neurology
Kuang Tien General Hospital