Trial Outcomes & Findings for Melatonin in Smoke-induced Vascular Injury (NCT NCT02591238)
NCT ID: NCT02591238
Last Updated: 2016-03-03
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
68 participants
Primary outcome timeframe
Three months
Results posted on
2016-03-03
Participant Flow
Time: Jun 10,2015 -Jun 24,2015. Address: factory clinic of Heilongjiang Airports Managements Group Co., Ltd and village clinic of Xinfa village Daoli district, Haerbin city, Heilongjiang province, China. Medical staff: 3 Registered medical practitioner and 4 registered nurse.
First in included 96 participants of both genders, 28 participants excluded (refused to randomly assigned n=9, not meeting inclusion criteria n=9, time improper n=8, unknown n=2). 5 participants withdraw during the trial (pregnant n=1, influenza n=1, personal circumstance n=2, unknown reason n=1).
Participant milestones
| Measure |
IV Non-smoker + Placebo
non-smoker oral placebo
non-smoker oral placebo: Participants oral placebo last 2 weeks.
|
III Non-smoker + Melatonin
non-smoker oral melatonin
non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks.
|
II Smoker + Placebo
smoker oral placebo
smoker oral placebo: Participants oral placebo last 2 weeks.
|
I Smoker + Melatonin
smoker oral melatonin
smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
17
|
17
|
18
|
|
Overall Study
COMPLETED
|
15
|
16
|
17
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
3
|
Reasons for withdrawal
| Measure |
IV Non-smoker + Placebo
non-smoker oral placebo
non-smoker oral placebo: Participants oral placebo last 2 weeks.
|
III Non-smoker + Melatonin
non-smoker oral melatonin
non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks.
|
II Smoker + Placebo
smoker oral placebo
smoker oral placebo: Participants oral placebo last 2 weeks.
|
I Smoker + Melatonin
smoker oral melatonin
smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks.
|
|---|---|---|---|---|
|
Overall Study
Pregnancy
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
|
Overall Study
influenza
|
0
|
0
|
0
|
1
|
|
Overall Study
personal circumstances
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Melatonin in Smoke-induced Vascular Injury
Baseline characteristics by cohort
| Measure |
IVnon-smoker + Placebo
n=15 Participants
non-smoker oral placebo
non-smoker oral placebo: Participants oral placebo last 2 weeks.
|
IIInon-smoker + Melatonin
n=16 Participants
non-smoker oral melatonin
non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks.
|
IIsmoker + Placebo
n=17 Participants
smoker oral placebo
smoker oral placebo: Participants oral placebo last 2 weeks.
|
Ismoker + Melatonin
n=15 Participants
smoker oral melatonin
smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
35.5 years
STANDARD_DEVIATION 3.4 • n=39 Participants
|
34.6 years
STANDARD_DEVIATION 3.8 • n=41 Participants
|
31.7 years
STANDARD_DEVIATION 3.4 • n=35 Participants
|
31.7 years
STANDARD_DEVIATION 2.8 • n=31 Participants
|
33.37 years
STANDARD_DEVIATION 3.1 • n=146 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
14 Participants
n=35 Participants
|
13 Participants
n=31 Participants
|
46 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
17 Participants
n=146 Participants
|
PRIMARY outcome
Timeframe: Three monthsPopulation: Bellow concentration data of Fbg was after treatment with oral melatonin 2 weeks.
Outcome measures
| Measure |
IV Non-smoker + Placebo
n=15 Participants
non-smoker oral placebo
non-smoker oral placebo: Participants oral placebo last 2 weeks.
|
III Non-smoker + Melatonin
n=16 Participants
non-smoker oral melatonin
non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks.
|
II Smoker + Placebo
n=17 Participants
smoker oral placebo
smoker oral placebo: Participants oral placebo last 2 weeks.
|
I Smoker + Melatonin
n=15 Participants
smoker oral melatonin
smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks.
|
|---|---|---|---|---|
|
Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of Fbg.
|
2.76 g/L
Standard Deviation 0.34
|
2.38 g/L
Standard Deviation 0.43
|
2.89 g/L
Standard Deviation 0.58
|
2.49 g/L
Standard Deviation 0.54
|
PRIMARY outcome
Timeframe: Three months.Population: Bellow concentration data of Glu was after treatment with oral melatonin 2 weeks.
Outcome measures
| Measure |
IV Non-smoker + Placebo
n=15 Participants
non-smoker oral placebo
non-smoker oral placebo: Participants oral placebo last 2 weeks.
|
III Non-smoker + Melatonin
n=16 Participants
non-smoker oral melatonin
non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks.
|
II Smoker + Placebo
n=17 Participants
smoker oral placebo
smoker oral placebo: Participants oral placebo last 2 weeks.
|
I Smoker + Melatonin
n=15 Participants
smoker oral melatonin
smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks.
|
|---|---|---|---|---|
|
Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of Glu.
|
4.4 mmol/L
Standard Deviation 1.36
|
4.24 mmol/L
Standard Deviation 1.3
|
5.02 mmol/L
Standard Deviation 1.26
|
4.79 mmol/L
Standard Deviation 1.05
|
PRIMARY outcome
Timeframe: Three months.Population: Below concentration data of FFA was after treatment with oral melatonin 2 weeks.
Outcome measures
| Measure |
IV Non-smoker + Placebo
n=15 Participants
non-smoker oral placebo
non-smoker oral placebo: Participants oral placebo last 2 weeks.
|
III Non-smoker + Melatonin
n=16 Participants
non-smoker oral melatonin
non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks.
|
II Smoker + Placebo
n=17 Participants
smoker oral placebo
smoker oral placebo: Participants oral placebo last 2 weeks.
|
I Smoker + Melatonin
n=15 Participants
smoker oral melatonin
smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks.
|
|---|---|---|---|---|
|
Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of FFA.
|
389 umol/L
Standard Deviation 121
|
382 umol/L
Standard Deviation 49
|
499 umol/L
Standard Deviation 84
|
425 umol/L
Standard Deviation 64
|
PRIMARY outcome
Timeframe: Three months.Population: Bellow concentration data of TC was after treatment with oral melatonin 2 weeks.
Outcome measures
| Measure |
IV Non-smoker + Placebo
n=15 Participants
non-smoker oral placebo
non-smoker oral placebo: Participants oral placebo last 2 weeks.
|
III Non-smoker + Melatonin
n=16 Participants
non-smoker oral melatonin
non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks.
|
II Smoker + Placebo
n=17 Participants
smoker oral placebo
smoker oral placebo: Participants oral placebo last 2 weeks.
|
I Smoker + Melatonin
n=15 Participants
smoker oral melatonin
smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks.
|
|---|---|---|---|---|
|
Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of TC.
|
4.51 mmol/L
Standard Deviation 1.04
|
4.5 mmol/L
Standard Deviation 0.95
|
4.74 mmol/L
Standard Deviation 0.8
|
4.45 mmol/L
Standard Deviation 0.65
|
PRIMARY outcome
Timeframe: Three months.Population: Bellow concentration data of TG was after treatment with oral melatonin 2 weeks.
Outcome measures
| Measure |
IV Non-smoker + Placebo
n=15 Participants
non-smoker oral placebo
non-smoker oral placebo: Participants oral placebo last 2 weeks.
|
III Non-smoker + Melatonin
n=16 Participants
non-smoker oral melatonin
non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks.
|
II Smoker + Placebo
n=17 Participants
smoker oral placebo
smoker oral placebo: Participants oral placebo last 2 weeks.
|
I Smoker + Melatonin
n=15 Participants
smoker oral melatonin
smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks.
|
|---|---|---|---|---|
|
Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of TG.
|
1.21 mmol/L
Standard Deviation 0.55
|
1.23 mmol/L
Standard Deviation 0.6
|
1.42 mmol/L
Standard Deviation 0.74
|
1.41 mmol/L
Standard Deviation 0.51
|
PRIMARY outcome
Timeframe: Three months.Population: Bellow concentration data of LDL-C was after treatment with oral melatonin 2 weeks.
Outcome measures
| Measure |
IV Non-smoker + Placebo
n=15 Participants
non-smoker oral placebo
non-smoker oral placebo: Participants oral placebo last 2 weeks.
|
III Non-smoker + Melatonin
n=16 Participants
non-smoker oral melatonin
non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks.
|
II Smoker + Placebo
n=17 Participants
smoker oral placebo
smoker oral placebo: Participants oral placebo last 2 weeks.
|
I Smoker + Melatonin
n=15 Participants
smoker oral melatonin
smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks.
|
|---|---|---|---|---|
|
Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of LDL-C.
|
1.85 mmol/L
Standard Deviation 0.54
|
1.95 mmol/L
Standard Deviation 0.52
|
2.2 mmol/L
Standard Deviation 0.75
|
2.19 mmol/L
Standard Deviation 0.47
|
Adverse Events
Non-smoker + Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-smoker + Melatonin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Smoker + Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Smoker + Melatonin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Prof. Changwei Liu. Director of vascular surgery.
Peking Union Medical College Hospital.
Phone: +86 1069152509
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place