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MelonCAC: Melatonin on Coronary Artery Calcification

Sponsor
Chinese PLA General Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03966235
Collaborator
(none)
74
Enrollment
1
Location
2
Arms
24
Anticipated Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Melatonin 3 mg
  • Drug: Placebo
 Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
74 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Effects of Melatonin on Progression of Coronary Artery Calcification
Anticipated Study Start Date :
Jun 1, 2019
Anticipated Primary Completion Date :
Jun 1, 2021
Anticipated Study Completion Date :
Jun 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Melatonin group

drug: melatonin tablets (Sigma-Aldrich Co. LLC, St. Louis, MO, USA); the frequency:3mg melatonin tablet was taken daily; duration: study treatment was maintained for 6 months.

Drug: Melatonin 3 mg
Melatonin was taken daily for 6 months.
Other Names:
  • melatonin

    		•
    Placebo Comparator: Control group

    drug: placebo tablet; the frequency: placebo tablet was taken daily; duration: study treatment was maintained for 6 months.

    Drug: Placebo
    Placebo tablet was taken daily for 6 months.

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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.

    2. malondialdehyde (MDA) level [at 6 months]

      a change in malondialdehyde (MDA) level at 6 months after treatment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 PLA general hospital Beijing China 100853

    Sponsors and Collaborators

    • Chinese PLA General Hospital

    Investigators

    • Principal Investigator: yu jie zhou, Beijing Anzhen Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Chen Wei Ren, MD, Prof., Chinese PLA General Hospital
    ClinicalTrials.gov Identifier:
    NCT03966235
    Other Study ID Numbers:
    • MelonCAC
    First Posted:
    May 29, 2019
    Last Update Posted:
    May 29, 2019
    Last Verified:
    May 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Chen Wei Ren, MD, Prof., Chinese PLA General Hospital
    melatonin
    coronary artery calcification
    adjuvant therapy
    Additional relevant MeSH terms:
    Arteriosclerosis
    Coronary Artery Disease
    Calcinosis
    Melatonin

    Study Results

    No Results Posted as of May 29, 2019