Table 1.
Data from https://clinicaltrials.gov, Updated on October 10th, 2023
| # | Title | Status | Conditions | Interventions and Dosing | Primary Outcome Measures | Secondary Outcome Measures | Study Phase | Number of Participants | Year |
|---|---|---|---|---|---|---|---|---|---|
| 1 | “Melatonin Supplements for Improving Sleep in Individuals with Hypertension”9 | Completed | Sleep disorders and hypertension | Melatonin vs placebo | Sleep quality, sleep efficiency measured by polysomnography (total sleep time as a percentage of 8 hours of sleep), measured following 3 weeks of melatonin/placebo supplementation. | Change in systolic blood pressure (SBP) measured by monitoring of ambulatory blood pressure (ABP) over 24 hours. Measurement taken following 3 weeks of supplementation and compared with baseline. | Phase II | 16 | 2010 |
| 2 | “Melatonin and Nighttime Blood Pressure in African Americans –24 mg Study”10 | Completed | Hypertension | Melatonin vs placebo | Mean nighttime SBP. Recording SBP using an ABP monitor. The period between self-reported sleep onset through to end of self-reported sleep was recorded. The mean values of many measurements were reported at the end of a 4-week period. The mean nighttime diastolic blood pressure (DBP) was recorded using an ABP monitor. The period between the onset of self-reported sleep through to the end of self-reported sleep was recorded. The mean values of many measurements were reported at the end of a 4-week period. |
Mean nighttime Mean Arterial Pressure (MAP) was measured. This measures the average blood pressure in the subject’s arteries during one complete heartbeat (cardiac cycle) at nighttime. The mean nighttime heart rate (HR), SBP and DBP over 24 hours were measured. The mean values of all measurements were reported at the end of a 4-week period. |
Phase II | 40 | 2014 |
| 3 | “Melatonin and Nighttime Blood Pressure in African Americans – 8 mg Study”11 | Completed | Hypertension | Melatonin vs placebo | Mean nighttime SBP. The nighttime SBP was recorded using an ABP monitor. Measurements were recorded from the onset through to the end of self-reported sleep. The mean values of many measurements were reported at the end of a 4-week period. Mean nighttime DBP. This was recorded using an ABP monitor. Measurements were recorded from the onset of self-reported sleep through to the end of self-reported sleep. The mean values of many measurements were reported at the end of a 4-week period. |
Nighttime MAP, mean nighttime HR, SBP, DBP were measured. The heart rate was calculated using ABP monitoring. Nocturnal BP was measured. Nocturnal BP is dipping represents the mean nocturnal to mean daytime systolic BP and diastolic BP ratios, equivalent to the percentage drop in nighttime SBP in comparison to SBP during the day. The percentage of participants displaying melatonin-related side effects after a 4-week treatment period. |
Phase II | 37 | 2014 |