Effects of Melatonin, as a Dietary Supplement, on Glycemic Parameters, Cardiovascular Disease Risk Factors, Bone Metabolism Markers and Quality of Life in Peritoneal Dialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 主要终点
- sICAM-1
研究概览
简要总结
The aim of this double-blind randomized clinical trial is to determine the effects of Melatonin on cardiovascular disease risk factors, bone metabolism markers, serum concentrations of advanced glycated end products and quality of life in peritoneal dialysis patients. Forty patients from peritoneal dialysis centers will randomly assign to either Melatonin or placebo group. The patients in Melatonin group will receive 5 mg Melatonin (as 1 tablet) daily for 10 weeks, while the placebo group will receive identical placebo. At the baseline and the end of the study,7 ml blood will be collected from each patient after a 12-14-hours fasting and Serum concentrations of malondialdehyde; high sensitivity c-reactive protein; Soluble intercellular adhesion molecule-1; glucose; pentosidine; carboxy-methyl lysine; Procollagen 1 Intact N-Terminal Propeptide; Tartrate-resistant acid phosphatase 5b; osteoprotegerin; Receptor activator of nuclear factor kappa-Β ligand; Intact parathyroid hormone; triglyceride; total cholesterol; High-density lipoprotein cholesterol; low-density lipoprotein cholesterol; lipoprotein-a; albumin; calcium; phosphorous; and also systolic blood pressure; diastolic blood pressure and questionnaires including quality of life; quality of sleep and depression will be assessed.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Continuous Ambulatory Peritoneal Dialysis for 6 months or more
- •Body mass index (BMI) below 35
排除标准
- •Infectious diseases (especially peritonitis) and inflammatory diseases Liver diseases
- •Past medical history of cancer Receiving glucocorticoid drugs, non-steroidal anti-inflammatory drugs
- •Receiving Melatonin supplements
结局指标
主要结局
sICAM-1
时间窗: 10 weeks
Serum concentrations of Soluble intercellular adhesion molecule-1
carboxy-methyl lysine
时间窗: 10 weeks
serum concentration of carboxy-methyl lysine
Osteoprotegerin
时间窗: 10 weeks
Serum concentrations of Osteoprotegerin
LDL-C
时间窗: 10 weeks
Serum concentrations of low-density lipoprotein cholesterol
the Beck depression test
时间窗: 10 weeks
Filling the Beck depression test
Lp (a)
时间窗: 10 weeks
Serum concentrations of lipoprotein-a
Diastolic blood pressure
时间窗: 10 weeks
Diastolic blood pressure (mmHg)
Total cholesterol
时间窗: 10 weeks
Serum concentrations of total cholesterol
MDA
时间窗: 10 weeks
Serum concentrations of malondialdehyde
hs-CRP
时间窗: 10 weeks
Serum concentrations of high sensitivity c-reactive protein
pentosidine
时间窗: 10 weeks
serum concentration of pentosidine
P1NP
时间窗: 10 weeks
serum concentration of Procollagen 1 Intact N-Terminal Propeptide
TRACP5b
时间窗: 10 weeks
Serum concentrations of Tartrate-resistant acid phosphatase 5b
triglyceride
时间窗: 10 weeks
Serum concentrations of triglyceride
glucose
时间窗: 10 weeks
serum concentration of fasting glucose
Systolic blood pressure
时间窗: 10 weeks
Systolic blood pressure (mmHg)
HDL-C
时间窗: 10 weeks
Serum concentrations of High-density lipoprotein cholesterol
RANKL
时间窗: 10 weeks
Serum concentrations of Receptor activator of nuclear factor kappa-Β ligand
Quality of life index (KDQOL) questionnaire
时间窗: 10 weeks
Filling the kidney disease quality of life index (KDQOL) questionnaire
Quality of sleep Pittsburgh Sleep Quality Index (PSQI) questionnaire
时间窗: 10 weeks
Filling the Pittsburgh Sleep Quality Index (PSQI) questionnaire
次要结局
- calcium(10 weeks)
- phosphorous(10 weeks)
- iPTH(10 weeks)
- albumin(10 weeks)
研究者
zahra yari
assistant professor
National Nutrition and Food Technology Institute