Melatonin and Risk Of Cardiovascular Events And Malignant Tumors In The Elderly

NCT04631341 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10000

Last updated 2020-11-17

No results posted yet for this study

Summary

Cardiovascular diseases and tumors seriously threaten human health. There are many risk factors that affect the occurrence and death of cardiovascular diseases and malignant tumors. In addition to genetic and congenital factors, it also includes bad lifestyles, such as smoking, drinking, abnormal metabolism, excessive stress, etc. Many factors such as excessive stress and staying up late can cause abnormal circadian rhythms. The regulation of circadian rhythm is likely to be a key key to the early prevention of cardiovascular diseases and tumors.

Melatonin has an important role in regulating the circadian rhythm of the human body. The latest research of our research group confirmed that melatonin can reduce the level of oxidative stress through the retinoic acid-related orphan nuclear receptor alpha (RORα) and thereby inhibit pathological cardiac hypertrophy; melatonin can regulate the polarization and polarization of macrophages RORα receptor stabilizes vulnerable plaque in arteries and prevents plaque rupture.

In China, melatonin is widely used in the market as a health product. However, the protective mechanism of melatonin in cardiovascular diseases and tumors is still unclear, and large-scale population intervention studies are still lacking. The level of melatonin in the daytime changes little with age, but the peak at night gradually decreases with age. In people aged 60 and above, the peak of melatonin at night decreased significantly. We speculate that melatonin supplementation may be able to reduce the oxidative damage of mitochondria by maintaining the level of melatonin at night in the body, delay cell decay, and delay this physiological process.

Therefore, the project team intends to combine the developed new cardiovascular disease and tumor risk prediction models in the Shanghai elderly cohort established in the early stage, and randomize groups of healthy people in the same risk stratification, according to whether or not to supplement melatonin. There are two cohorts: the melatonin intervention cohort and the parallel control cohort. By observing the efficacy indicators of cardiovascular disease and tumor incidence in the two groups during the follow-up period, it provides evidence-based medical evidence for the future clinical application of melatonin.

Conditions

Interventions

DIETARY_SUPPLEMENT

Melatonin

Melatonin 5mg every night, for one year

Sponsors & Collaborators

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    collaborator OTHER
  • Tongji Hospital

    collaborator OTHER
  • Huadong Hospital

    collaborator OTHER
  • ShuGuang Hospital

    collaborator OTHER
  • RenJi Hospital

    lead OTHER

Principal Investigators

  • Jun Pu, MD,PhD · RenJi Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2026-01-01
Completion
2026-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04631341 on ClinicalTrials.gov