Melatonin on Coronary Artery Calcification (MelonCAC)

May 28, 2019 updated by: Chen Wei Ren, MD, Chinese PLA General Hospital

Effects of Melatonin on Progression of Coronary Artery Calcification

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

74

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100853
        • Recruiting
        • PLA General Hospital
        • Contact:
          • wei ren chen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Investigators

  • Principal Investigator: yu jie zhou, Beijing Anzhen Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2019

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

May 26, 2019

First Submitted That Met QC Criteria

May 28, 2019

First Posted (Actual)

May 29, 2019

Study Record Updates

Last Update Posted (Actual)

May 29, 2019

Last Update Submitted That Met QC Criteria

May 28, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MelonCAC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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