NCT04336566已完成不适用
Renal Function in Chronic Kidney Disease and the Effect of Exogenous Melatonin Administration (REM TRIAL)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Change in Albuminuria
研究概览
简要总结
This will be a prospective, double blinded, randomized, controlled pilot study to determine if there is any correlation between melatonin administration and proteinuria.
详细描述
Investigators plan to enroll up to 100 eligible participants in this pilot trial with 50 participants randomized to receive melatonin and 50 patients randomized to receive a placebo. Participants will be randomized on a rolling basis; meaning, once participants agree to enroll in the study, the participant will be placed randomly into either group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participant, care provider, data manager/monitor, principle investigator all blinded
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are between ages 18 and up with chronic kidney disease (CKD) I-III (stage 3 kidney disease, kidney dysfunction)
- •Random urine microalbumin of 30 mcg or greater (protein in the urine)
- •Have ability to complete a sleep survey
- •Currently not on melatonin therapy.
排除标准
- •End Stage Renal Disease
- •CKD Stage IV (stage 4 with severe kidney dysfunction)
- •Severe liver disease
- •Chronic dialysis therapy
结局指标
主要结局
Change in Albuminuria
时间窗: 6 months
protein in urine
次要结局
- Potassium levels(6 months)
- Urinalysis(6 months)
- Creatinine levels(6 months)
- Blood Urea Nitrogen (BUN) levels(6 months)
- Surveys including Pittsburgh Sleep Quality Index (PSQI) questionnaire(6 months)
- Sodium levels(6 months)
- Bicarbonate levels(6 months)
- Chloride levels(6 months)
研究者
研究点 (2)
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