Effect Of Melatonin On The Clinical Outcome In Pediatric Hemodialysis Patients
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in baseline Malondialdehyde (MDA) level.
研究概览
简要总结
A Prospective, randomized, double-blinded, placebo-controlled trial will be conducted at the pediatric dialysis unit, Children's Hospital, Ain Shams University in order to investigate the benefits of melatonin supplementation on oxidative stress, inflammation and to assess sleep quality by using PSQI questionnaire in pediatric hemodialysis patients.
详细描述
- Patients will be recruited and evaluated for eligibility.
- Patients who meet the eligibility criteria will be randomly assigned to either placebo or intervention group.
- Patient demographics, clinical characteristics and full medical and medication history: will be obtained at baseline and every 4 weeks after the beginning of the study.
- Blood samples will be withdrawn from each patient before the dialysis session for assay of each of the following:
1.Oxidative stress marker malondialdehyde (MDA) by ELISA assay. 2. Inflammatory marker level nuclear factor kappa B (NF-KB) by ELISA assay 3. Complete blood picture (CBC). 4. Lipid profile (total cholesterol(TC), triglycerides(TG), high-density lipoprotein (HDL) and low-density lipoprotein (LDL) 5)Safety will be assessed weekly after the beginning of the study by monitoring the side effects or any adverse drug reactions.
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A total of (40) patients on regular HD will be enrolled in the study. These patients will be randomly assigned in a 1:1 ratio into two groups:
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The first group (n=20):The patients in the first group will receive a total daily dose of 5mg of melatonin tablets 1-hour before bedtime for 12 weeks.
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The second group (n=20): The patients will receive one tablet of placebo for the same duration.
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All subjects will sign an informed consent statement prior to inclusion in the study.
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All subjects will be followed up weekly for 12 weeks and blood samples will be withdrawn at baseline and the end of the study.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients age from 6-18 years old.
- •Undergoing regular HD for at least 6 months prior to enrollment
- •Not enrolled in any other clinical trial.
- •Judged by the physician to be physically stable
排除标准
- •Patients receiving anti-epileptics.
- •Patients with some autoimmune conditions as SLE, RA or post-organ transplant
- •Patients taking immunosuppressants.
- •Patients taking warfarin.
- •Patients receiving vitamin E, green tea or zinc during the past 3 months
- •Patients with malignancy and/or active inflammatory disease
- •Patients with mal absorption, mental retardation or psychiatric illness.
- •Patients who had hemorrhagic episodes or received blood transfusion in the past 3 months prior to the enrollment.
结局指标
主要结局
Change in baseline Malondialdehyde (MDA) level.
时间窗: At baseline and at 12 weeks.
Oxidative stress marker
次要结局
- Change in baseline nuclear factor kappa B (NF-KB) level.(At baseline and at 12 weeks.)
- Change in sleep quality by using Pittsburgh Sleep Quality Index (PSQI) questionnaire(At baseline and at 12 weeks.)
研究者
Ghadeer Amged
Demonstrator of clinical pharmacy
Ain Shams University