This trial is active, not recruiting.

Condition hypertension
Treatments melatonin, placebo pills
Phase phase 2
Sponsor Emory University
Collaborator National Center for Complementary and Alternative Medicine (NCCAM)
Start date March 2010
End date December 2013
Trial size 40 participants
Trial identifier NCT01114360, 1R21AT004509-01A2, IRB00021300


This purpose of this study is to test the effect of oral melatonin supplementation (8 mg per night for 4 weeks) on nighttime blood pressure in African Americans with a history of elevated nighttime blood pressure.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (subject, investigator)
Primary purpose treatment
(Active Comparator)
Nightly dose of Melatonin 8 mg for 4 weeks.
8 mg time-release melatonin pills, once per night for 4 weeks
(Placebo Comparator)
Placebo pill at 8 mg on a nightly dose for 4 weeks.
placebo pills
Placebo pills, once per night for 4 weeks

Primary Outcomes

Nighttime ambulatory blood pressure
time frame: After 4 weeks of treatment

Secondary Outcomes

Daytime ambulatory blood pressure
time frame: After 4 weeks of treatment
Sleep duration and quality
time frame: After 4 weeks of treatment
Urinary catecholamines
time frame: After 4 weeks of treatment
Markers of endothelial function
time frame: After 4 weeks of treatment
Melatonin-related side effects
time frame: After 4 weeks of treatment

Eligibility Criteria

Male or female participants from 18 years up to 64 years old.

Inclusion Criteria: - Males or females ages 18 to 64 - Prior history of elevated nighttime BP (>125 mmHg SBP) - Taking no more than 2 antihypertensive medications - African-American race (self-defined by the participant) Exclusion Criteria: - Secondary forms of hypertension - Presence of other diseases requiring treatment with BP lowering medications - Known cardiovascular disease (including history of angina pectoris, heart failure, presence of a cardiac pacemaker, history of myocardial infarction or revascularization procedure, or cerebrovascular disease, including stroke and TIA) - Diabetes mellitus (type 1 or 2) - Cancer/Malignancy other than nonmelanoma skin cancer - Primary renal disease - Serum creatinine > 1.5 in men or > 1.4 in women - Severe anemia - Liver enzymes > 2.5 upper limits of normal - Hepatitis B, Hepatitis C, or HIV positive as assessed by questionnaire - Current treatment with or regular use of calcium channel blocking agents, COX2-inhibitors, oral contraceptives, estrogen, sildenafil, vardenafil, tadalafil, antidepressants, corticosteroids, or warfarin - Current use of melatonin or any sleep aids containing melatonin. - Regular consumption (1 or more times per week) of any of the following of Vitamin methyl B12, St. Johns Wort, Feverfew, black and white mustard seeds, wolf berry seed - Sleep apnea - Night work - Women who are pregnant, breast-feeding, attempting conception, or planning to attempt conception over the next 6 months.

Additional Information

Official title Melatonin and Nighttime Blood Pressure in African Americans
Principal investigator Frederic F Rahbari Oskoui, MD, MSCR
Description The main outcome of interest is the mean nighttime blood pressure. We are also trying to see the mechanism of action of melatonin on blood pressure by analyzing data from sleep studies (to see if Melatonin lower blood pressure by providing a better quality of sleep or is that independent of the quality of sleep. We are also looking into the effect of melatonin on sympathetic nervous system by measuring urinary catecholamines. Finally, we are looking into changes in vascular biology markers P-selectine and e-selectine) on Melatonin.
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by Emory University.