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临床试验/NCT03945955
NCT03945955已完成4 期

Melatonin Supplementation and Oxidative DNA Damage Repair Capacity Among Night Shift Workers: a Randomized Placebo-controlled Trial

University of British Columbia1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年6月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
40
试验地点
1
主要终点
Oxidative DNA damage repair capacity

研究概览

简要总结

This research aims to determine if melatonin supplementation, through improvements in sleep quality, increases the ability to repair oxidative DNA damage and reduce lipid peroxidation levels among nightshift workers.

详细描述

Administering a 3 mg melatonin supplement to nightshift workers prior to day sleep may significantly improve their oxidative DNA damage repair capacity and reduce the occurrence of lipid peroxidation [measured as increased excretion of urinary 8-hydroxydeoxyguanosine (8-OH-dG) and decreased excretion of urinary 8-isoprostane, respectively] through improvements in sleep quality (measured via actigraphy) and melatonin's direct antioxidative properties.

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, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Eligibility criteria included: 1) living and working in the Greater Vancouver area; 2) being between the ages of 18 and 50; 3) having a body mass index (BMI) between 18.5 and 30 kg/m2; 4) working at least two consecutive night shifts per week (≥7 hours per night ending no earlier than 06:00) for at least six months; 5) sleeping, on average, six hours during day sleep periods; 6) not currently using marijuana or illicit drugs; 7) no personal history of sleep disorders, hormone disorders, seizure disorders, or chronic medical conditions (e.g., cancer, diabetes, kidney disease, liver disease, asthma, cardiovascular disease, and infectious disease); 8) not currently pregnant or currently breast feeding; 9) no trans-meridian travel within fours weeks of data collection; and 10) not currently using melatonin supplements.

排除标准

  • 未提供

研究组 & 干预措施

Placebo

Placebo Comparator

干预措施: Placebo (Other)

Melatonin

Experimental

干预措施: Melatonin (Dietary Supplement)

结局指标

主要结局

Oxidative DNA damage repair capacity

时间窗: During day sleep and during night work at baseline and one month

Measured as urinary concentration of 8-hydroxydeoxyguanosine (ng/mg-Creatinine) between baseline and one month as measured using liquid chromatography tandem mass spectrometry

Sleep duration

时间窗: During day sleep at baseline and one month

Measured sleep duration (total minutes asleep) using wrist-based actigraphy device

Karolinska Sleepiness Scale

时间窗: During night shift work at baseline and one month

Self-reported level of sleepiness on 9 point scale

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Parveen Bhatti

Associate Professor

University of British Columbia

研究点 (1)

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