Melatonin on Coronary Artery Calcification

Effects of Melatonin on Progression of Coronary Artery Calcification

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03966235

Acronym

MelonCAC

Enrollment

Registered

2019-05-29

Start date

2019-06-01

Completion date

2021-06-01

Last updated

2019-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Calcification

Keywords

melatonin, coronary artery calcification, adjuvant therapy

Brief summary

We planned to evaluate the effects of melatonin on progression of coronary artery calcification (CAC) in patients with moderate calcified coronary atherosclerosis.

Detailed description

CAC is prevalent in coronary artery disease (CHD), and the extent of CAC predicts cardiovascular risk. The causes of CAC include dysregulated matrix metabolism, epitaxial mineral deposition, inflammation, oxidative stress, and apoptosis. Melatonin is the main indoleamine produced by the pineal gland; it is known recently to have anti-inflammatory, anti-cancer and antioxidant activities. Several studies have shown that melatonin protects against inflammation and apoptosis in vascular calcification. Melatonin also inhibits oxidative stress-induced apoptosis and calcification in endplate chondrocytes. The investigators planned to determine the efficacy of melatonin on progression of coronary artery calcification (CAC) in patients with moderate calcified coronary atherosclerosis. This study may shed light as to whether oral melatonin supplementation can be an adjunct therapy in CAC patients.

Interventions

DRUGMelatonin 3 mg

Melatonin was taken daily for 6 months.

DRUGPlacebo

Placebo tablet was taken daily for 6 months.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

Patients with a documented Agatston score≥30 and moderate calcified coronary atherosclerosis (\<50% diameter lumen narrowing) were eligible for the study.

Exclusion criteria

1. unstable angina pectoris 2. symptomatic chronic heart failure and/or left ventricular ejection fraction (EF) \<40% 3. atrial fibrillation or other arrhythmias 4. type I diabetes mellitus or uncontrolled type II diabetes mellitus 5. renal failure 6. liver disease 7. gastrointestinal disease that affected absorption

Design outcomes

Primary

Measure	Time frame	Description
a change in CAC score at 6 months measured by coronary CTA	at 6 months	The primary efficacy endpoint was the effect of melatonin on the change in CAC score at 6 months compared with placebo.

Secondary

Measure	Time frame	Description
high-sensitivity C-reactive protein (hsCRP) level	at 6 months	a change in high-sensitivity C-reactive protein (hsCRP) level at 6 months after treatment.
malondialdehyde (MDA) level	at 6 months	a change in malondialdehyde (MDA) level at 6 months after treatment.

Countries

China

Contacts

Primary Contactwei ren chen, MD

chen_weiren@sina.com+8601066876231

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026