NCT03966235

Melatonin on Coronary Artery Calcification

Effects of Melatonin on Progression of Coronary Artery Calcification

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Calcification

Interventions

Type	Name	Description
DRUG	Melatonin 3 mg	Melatonin was taken daily for 6 months.
DRUG	Placebo	Placebo tablet was taken daily for 6 months.

Timeline

• Start date: 2019-06-01
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2019-05-29
• Last updated: 2019-05-29

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study