The Effects of Low Dose Naltrexone (LDN) on Diseases of Aging - A Retrospective Cross-sectional Study Into Off-label Use of LDN
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Quality of life score
研究概览
简要总结
This retrospective, observational study will assess the health status of short- and long-term low-dose naltrexone (LDN) users.
详细描述
Long-term (>5 years), intermediate-term (1-5 years), and short-term low-dose naltrexone (LDN) users (<12 months) will be contacted for a retrospective, observational assessment of their health status. Participants will be asked to complete a series of questionnaires assessing their quality of life, general physical and mental health, family history, the occurrence of age-related diseases, and immune status. Additionally, blood tests for immune and longevity markers will be optional for a subset of participants.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (aged 18-120)
- •Any ethnicity
- •Taking LDN
- •Willing to complete health questionnaires
- •Technologically competent to complete web forms
- •Subgroup: willing to undergo blood testing
排除标准
- •LDN doses over 20 mg/day
- •Terminal cancer patients (defined as stage IV and/or with a life expectancy of 12 months or less)
研究组 & 干预措施
Long-term (>5 years) LDN users
Participants who have been using LDN for over 5 years
干预措施: low-dose naltrexone (Drug)
intermediate-term (1-5 years) LDN users
Participants who have been using LDN for at least 1 year, but shorter than 5 years.
干预措施: low-dose naltrexone (Drug)
short-term (<12 months) LDN users
Participants who have been using LDN for less than a year. This group will serve as the control group.
干预措施: low-dose naltrexone (Drug)
结局指标
主要结局
Quality of life score
时间窗: At enrollment
The short-form (SF)-36 Questionnaire generates scores in the categories: physical function, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. Scores up to maximum 100, with higher scores representing better quality of life
Immune Status
时间窗: At enrollment
Immune Status Questionnaire (ISQ) to define a measure of perceived immune status, consists of seven representative immune-associated symptoms and diseases. The Immune Status Questionnaire scores respondents out of 10, with 10 being a better outcome and lower scores worse outcome.
次要结局
- CMV IgG(At enrollment)
- General health and family history(At enrollment)
- Levine's phenotypic age(At enrollment)
- CD4/CD8 ratio(At enrollment)
- hsCRP(At enrollment)
- IL-6(At enrollment)
- TNFɑ(At enrollment)
- Methylation age clock testing(At enrollment)