Coronary Artery CalcificationPhase 4MelonCACNCT03966235
Melatonin on Coronary Artery Calcification
A Phase 4 study testing Melatonin 3 mg in people with Coronary Artery Calcification, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
We planned to evaluate the effects of melatonin on progression of coronary artery calcification (CAC) in patients with moderate calcified coronary atherosclerosis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Calcification
- What is being tested?
- Melatonin 3 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2019to 1 Jun 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a documented Agatston score≥30 and moderate calcified coronary atherosclerosis (<50% diameter lumen narrowing) were eligible for the study.
Who cannot join
- unstable angina pectoris
- symptomatic chronic heart failure and/or left ventricular ejection fraction (EF) <40%
- atrial fibrillation or other arrhythmias
- type I diabetes mellitus or uncontrolled type II diabetes mellitus
- renal failure
- liver disease
- gastrointestinal disease that affected absorption
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
PLA general hospital
Beijing, 100853
wei ren chen
About this study
Official title: 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.
Read the 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
- Being tested
- Melatonin 3 mg, Placebo
- Keywords
- melatonin, coronary artery calcification, adjuvant therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin 3 mgDrug
Also called melatonin
Melatonin was taken daily for 6 months.
PlaceboDrug
Placebo tablet was taken daily for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Melatonin group | Experimental | 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. Receives: Drug: Melatonin 3 mg |
| Control group | Placebo comparator | drug: placebo tablet; the frequency: placebo tablet was taken daily; duration: study treatment was maintained for 6 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
a 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.
Measured: at 6 months
Secondary outcomes (2)
high-sensitivity C-reactive protein (hsCRP) level
a change in high-sensitivity C-reactive protein (hsCRP) level at 6 months after treatment.
Measured: at 6 months
malondialdehyde (MDA) level
a change in malondialdehyde (MDA) level at 6 months after treatment.
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start1 Jun 2019 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery CalcificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Wei Ren, MD, Chinese PLA General Hospital
- Investigators
- yu jie zhou, Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966235
- Sponsor's protocol ID
- MelonCAC
- Acronym
- MelonCAC
- Status last verified
- May 2019
- First submitted
- 26 May 2019
- Last updated
- 29 May 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gilham D, Tsujikawa LM, Sarsons CD, Halliday C, Wasiak S, Stotz SC, Jahagirdar R, Sweeney M, Johansson JO, Wong NCW, Kalantar-Zadeh K, Kulikowski E. Apabetalone downregulates factors and pathways associated with vascular calcification. Atherosclerosis. 2019 Jan;280:75-84. doi: 10.1016/j.atherosclerosis.2018.11.002. Epub 2018 Nov 14.
PubMed 30476723Shobeiri N, Bendeck MP. Interleukin-1beta Is a Key Biomarker and Mediator of Inflammatory Vascular Calcification. Arterioscler Thromb Vasc Biol. 2017 Feb;37(2):179-180. doi: 10.1161/ATVBAHA.116.308724. No abstract available.
PubMed 28122774Fernandez A, Ordonez R, Reiter RJ, Gonzalez-Gallego J, Mauriz JL. Melatonin and endoplasmic reticulum stress: relation to autophagy and apoptosis. J Pineal Res. 2015 Oct;59(3):292-307. doi: 10.1111/jpi.12264. Epub 2015 Aug 9.
PubMed 26201382Dehdashtian E, Mehrzadi S, Yousefi B, Hosseinzadeh A, Reiter RJ, Safa M, Ghaznavi H, Naseripour M. Diabetic retinopathy pathogenesis and the ameliorating effects of melatonin; involvement of autophagy, inflammation and oxidative stress. Life Sci. 2018 Jan 15;193:20-33. doi: 10.1016/j.lfs.2017.12.001. Epub 2017 Dec 5.
PubMed 29203148Wang Z, Ni L, Wang J, Lu C, Ren M, Han W, Liu C. The protective effect of melatonin on smoke-induced vascular injury in rats and humans: a randomized controlled trial. J Pineal Res. 2016 Mar;60(2):217-27. doi: 10.1111/jpi.12305. Epub 2016 Jan 13.
PubMed 26681403
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Melatonin on Progression of Coronary Artery Calcification
- ClinicalTrials.gov ID
- NCT03966235
- Acronym / sponsor ID
- MelonCAC / MelonCAC
- Conditions
- Coronary Artery Calcification
- Keywords
- melatonin, coronary artery calcification, adjuvant therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Jun 2019 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 29 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin group | Experimental | Drug: Melatonin 3 mgdrug: 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. |
| Control group | Placebo comparator | Drug: Placebodrug: placebo tablet; the frequency: placebo tablet was taken daily; duration: study treatment was maintained for 6 months. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a documented Agatston score≥30 and moderate calcified coronary atherosclerosis (<50% diameter lumen narrowing) were eligible for the study.
Key exclusion criteria (7 listed)
- unstable angina pectoris
- symptomatic chronic heart failure and/or left ventricular ejection fraction (EF) <40%
- atrial fibrillation or other arrhythmias
- type I diabetes mellitus or uncontrolled type II diabetes mellitus
- renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin 3 mgAlso: melatoninMelatonin was taken daily for 6 months. | Drug | Melatonin group |
| PlaceboPlacebo tablet was taken daily for 6 months. | Drug | Control group |
Primary outcome
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.
2 secondary outcomes
high-sensitivity C-reactive protein (hsCRP) level
Time frame: at 6 months
malondialdehyde (MDA) level
Time frame: at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
- Background: PubMed 30476723Gilham D, Tsujikawa LM, Sarsons CD, Halliday C, Wasiak S, Stotz SC, Jahagirdar R, Sweeney M, Johansson JO, Wong NCW, Kalantar-Zadeh K, Kulikowski E. Apabetalone downregulates factors and pathways associated with vascular calcification. Atherosclerosis. 2019 Jan;280:75-84. doi: 10.1016/j.atherosclerosis.2018.11.002. Epub 2018 Nov 14.
- Background: PubMed 28122774Shobeiri N, Bendeck MP. Interleukin-1beta Is a Key Biomarker and Mediator of Inflammatory Vascular Calcification. Arterioscler Thromb Vasc Biol. 2017 Feb;37(2):179-180. doi: 10.1161/ATVBAHA.116.308724. No abstract available.
- Background: PubMed 26201382Fernandez A, Ordonez R, Reiter RJ, Gonzalez-Gallego J, Mauriz JL. Melatonin and endoplasmic reticulum stress: relation to autophagy and apoptosis. J Pineal Res. 2015 Oct;59(3):292-307. doi: 10.1111/jpi.12264. Epub 2015 Aug 9.
- Background: PubMed 29203148Dehdashtian E, Mehrzadi S, Yousefi B, Hosseinzadeh A, Reiter RJ, Safa M, Ghaznavi H, Naseripour M. Diabetic retinopathy pathogenesis and the ameliorating effects of melatonin; involvement of autophagy, inflammation and oxidative stress. Life Sci. 2018 Jan 15;193:20-33. doi: 10.1016/j.lfs.2017.12.001. Epub 2017 Dec 5.
- Results publication: PubMed 26681403Wang Z, Ni L, Wang J, Lu C, Ren M, Han W, Liu C. The protective effect of melatonin on smoke-induced vascular injury in rats and humans: a randomized controlled trial. J Pineal Res. 2016 Mar;60(2):217-27. doi: 10.1111/jpi.12305. Epub 2016 Jan 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yu jie zhou principal investigator
Beijing Anzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Melatonin 3 mg in people with Coronary Artery Calcification, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact wei ren chen, MD (+8601066876231, chen_weiren@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
a change in CAC score at 6 months measured by coronary CTA (time frame: at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03966235, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2019.