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NCT04631341

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

Not yet recruiting NA Last updated 17 November 2020
What this trial tests

NA trial testing Melatonin in Cardiovascular Diseases in 10,000 participants. Not yet recruiting.

Timeline
1 January 2021
Primary endpoint
1 January 2026
31 December 2026

Quick facts

Lead sponsorRenJi Hospital
PhaseNA
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment10,000
Start date1 January 2021
Primary completion1 January 2026
Estimated completion31 December 2026

Drugs / interventions tested

Conditions studied

Sponsor

RenJi Hospital

Who can join

Adults 60 to 74, any sex, with Cardiovascular Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Nuclear receptors in health and disease: signaling pathways, biological functions and pharmaceutical interventions.
    Jin P, Duan X, Huang Z, Dong Y, et al · · 2025 · cited 21× · PMID 40717128 · DOI 10.1038/s41392-025-02270-3
  2. Oxidative Stress Management in Cardiorenal Diseases: Focus on Novel Antidiabetic Agents, Finerenone, and Melatonin.
    Theofilis P, Vordoni A, Kalaitzidis RG. · · 2022 · cited 11× · PMID 36295098 · DOI 10.3390/life12101663
  3. Effect of Cellular Senescence in Disease Progression and Transplantation: Immune Cells and Solid Organs.
    Kirchner VA, Badshah JS, Hong SK, Martinez O, et al · · 2024 · cited 8× · PMID 37953486 · DOI 10.1097/tp.0000000000004838
  4. Potential of melatonin to reverse epigenetic aberrations in oral cancer: new findings.
    Gil-Martín E, Ramos E, López-Muñoz F, Egea J, et al · · 2023 · PMID 38234969 · DOI 10.17179/excli2023-6624

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Other trials of Melatonin

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