We planned to evaluate the effects of melatonin on progression of coronary artery calcification (CAC) in patients with moderate calcified coronary atherosclerosis.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
74
Melatonin was taken daily for 6 months.
Placebo tablet was taken daily for 6 months.
PLA general hospital
Beijing, China
RECRUITINGa change in CAC score at 6 months measured by coronary CTA
The primary efficacy endpoint was the effect of melatonin on the change in CAC score at 6 months compared with placebo.
Time frame: at 6 months
high-sensitivity C-reactive protein (hsCRP) level
a change in high-sensitivity C-reactive protein (hsCRP) level at 6 months after treatment.
Time frame: at 6 months
malondialdehyde (MDA) level
a change in malondialdehyde (MDA) level at 6 months after treatment.
Time frame: at 6 months
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