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

NCT04631341 | Not Yet Recruiting DMC

• 1 other identifier: Melatonin Intervention Study
• Study Type: interventional
• Target: 10,000
• Locations: 0 countries
• Sites: N/A

Brief 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

Cardiovascular Diseases

Keywords

Cohort study; Natural Population; China

Outcome Measures

Primary Outcomes (1)

• Total cancer and cardiovascular disease incidence

  The primary cancer endpoint will be total cancer incidence (excluding non-melanoma skin cancer). For cardiovascular disease (CVD), the primary endpoint will be a composite endpoint of myocardial infarction, stroke, and CVD incidence.

  up to five years

Secondary Outcomes (1)

• Cancer mortality and a composite endpoint adding revascularization procedures of coronary artery bypass grafting and percutaneous coronary intervention

  up to five years

Study Arms (2)

Melatonin Group

EXPERIMENTAL

Take melatonin supplements

Dietary Supplement: Melatonin

Normal Control Group

NO INTERVENTION

Don't take melatonin supplements

Interventions

Melatonin DIETARY_SUPPLEMENT

Melatonin 5mg every night, for one year

Melatonin Group

Eligibility Criteria

• Age: 60 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Queue members;
• Han nationality;
• Between 60-74 years old, no gender limit;
• Women are in menopause;
• Patients without a history of malignant tumors (except for non-melanoma skin cancer), myocardial infarction, stroke, transient ischemic attack (TIA), angina, coronary artery bypass graft (CABG) or Percutaneous Coronary Intervention;
• No mental illness;
• No history of supplement allergy or supplement allergy;
• Subjects voluntarily participate in this study, sign an informed consent form, have good compliance, and cooperate with follow-up.

You may not qualify if:

• People who have difficulty swallowing or have known supplementary malabsorption;
• Have received any other clinical trial treatment within 1 year;
• The subject has a known, active or suspicious autoimmune disease;
• The subject has severe infections, including but not limited to infections requiring hospitalization, bacteremia, severe pneumonia, etc.;
• The subject has used a live attenuated vaccine in the past 30 days;
• The subject has been taking antidepressant medication before or is taking;
• Use of anticoagulants at baseline, history of kidney stones, renal failure or dialysis, hypercalcemia, hypoparathyroidism or hyperthyroidism, severe liver disease (cirrhosis), sarcoidosis or other granulomatous diseases, such as Active chronic tuberculosis or Wegener's granulomatosis, dementia, epilepsy, rheumatoid arthritis, sleep apnea syndrome, alcoholism;
• Situations deemed unsuitable by other researchers.

Sponsors & Collaborators

• RenJi Hospital: lead
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Tongji Hospital: collaborator
• Huadong Hospital: collaborator
• ShuGuang Hospital: collaborator

Related Publications (5)

• Xu L, Su Y, Zhao Y, Sheng X, Tong R, Ying X, Gao L, Ji Q, Gao Y, Yan Y, Yuan A, Wu F, Lan F, Pu J. Melatonin differentially regulates pathological and physiological cardiac hypertrophy: Crucial role of circadian nuclear receptor RORalpha signaling. J Pineal Res. 2019 Sep;67(2):e12579. doi: 10.1111/jpi.12579. Epub 2019 Apr 24.

  PMID: 30958896 BACKGROUND

• Ding S, Lin N, Sheng X, Zhao Y, Su Y, Xu L, Tong R, Yan Y, Fu Y, He J, Gao Y, Yuan A, Ye L, Reiter RJ, Pu J. Melatonin stabilizes rupture-prone vulnerable plaques via regulating macrophage polarization in a nuclear circadian receptor RORalpha-dependent manner. J Pineal Res. 2019 Sep;67(2):e12581. doi: 10.1111/jpi.12581. Epub 2019 May 14.

  PMID: 31009101 BACKGROUND

• Zhao Y, Xu L, Ding S, Lin N, Ji Q, Gao L, Su Y, He B, Pu J. Novel protective role of the circadian nuclear receptor retinoic acid-related orphan receptor-alpha in diabetic cardiomyopathy. J Pineal Res. 2017 Apr;62(3). doi: 10.1111/jpi.12378. Epub 2017 Feb 22.

  PMID: 27862268 BACKGROUND

• Zhao YC, Xu LW, Ding S, Ji QQ, Lin N, He Q, Gao LC, Su YY, Pu J, He B. Nuclear receptor retinoid-related orphan receptor alpha deficiency exacerbates high-fat diet-induced cardiac dysfunction despite improving metabolic abnormality. Biochim Biophys Acta Mol Basis Dis. 2017 Aug;1863(8):1991-2000. doi: 10.1016/j.bbadis.2016.10.029. Epub 2016 Nov 5.

  PMID: 27825849 BACKGROUND

• He B, Zhao Y, Xu L, Gao L, Su Y, Lin N, Pu J. The nuclear melatonin receptor RORalpha is a novel endogenous defender against myocardial ischemia/reperfusion injury. J Pineal Res. 2016 Apr;60(3):313-26. doi: 10.1111/jpi.12312. Epub 2016 Feb 16.

  PMID: 26797926 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Melatonin

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Jun Pu, MD,PhD

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Pu, MD,PhD

CONTACT

86-21-68383477; pujun310@hotmail.com

Song Ding, MD,PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiovascular Medicine

Study Record Dates

• First Submitted: August 16, 2020
• First Posted: November 17, 2020
• Study Start: January 1, 2021
• Primary Completion: January 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 17, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share