Phase 2
Completed N=40
Melatonin and Nighttime Blood Pressure in African Americans--24 mg Study
Source: ClinicalTrials.gov NCT01114373 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcomePrimary: Mean Nighttime Systolic Blood Pressure (SBP) — 126.6; 127.9 mmHg — p=0.0269
Summary
The purpose of this study is to test the effect of oral melatonin supplementation (24 mg per night for 4 weeks) on nighttime blood pressure in African Americans with a history of elevated nighttime blood pressure.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Nighttime Systolic Blood Pressure (SBP) |
126.6; 127.9 | 0.0269 sig |
| PRIMARY Mean Nighttime Diastolic Blood Pressure (DBP) |
77.2; 77.6 | 0.0492 sig |
| SECONDARY Mean Nighttime Mean Arterial Pressure (MAP) |
93.9; 94.4 | 0.91 |
| SECONDARY Mean Nighttime Heart Rate (HR) |
74.1; 74.4 | 0.88 |
| SECONDARY Mean Daytime Systolic Blood Pressure (SBP) |
134.2; 137.3 | 0.16 |
| SECONDARY Mean Daytime Diastolic Blood Pressure (DBP) |
85.3; 86.6 | 0.12 |
| SECONDARY Mean Daytime Mean Arterial Pressure (MAP) |
101.26; 103.5 | 0.12 |
| SECONDARY Mean Daytime Heart Rate (HR) |
81.6; 83.3 | 0.21 |
| SECONDARY Urinary Dopamine Excretion Rate |
115.5; 130.8 | 0.06 |
| SECONDARY Urinary Noradrenaline Excretion Rate |
11.5; 17 | 0.21 |
| SECONDARY Urinary Adrenaline Excretion Rate |
1.23; 1.76 | 0.41 |
| SECONDARY Plasma E-Selectin |
39.5; 41.0 | 0.13 |
| SECONDARY Plasma P-Selectin |
92.2; 98.6 | 0.58 |
| SECONDARY Total Sleep Time |
415.8; 413.4 | 0.39 |
Eligibility Criteria
Inclusion Criteria
- Males or females ages 18 to 64
- Prior history of elevated nighttime blood pressure (BP) ((systolic blood pressure (SBP) > 115mmHg))
- Taking no more than 2 antihypertensive medications
- African American (self-defined by the participant)
Exclusion Criteria
- Secondary forms of hypertension
- Presence of other diseases requiring treatment with BP lowering medication
- Known cardiovascular disease (including history of angina pectoris, heart failure, presence of a cardiac pacemaker, history of myocardial infarction or revascularization procedure, or history of cerebrovascular disease, including stroke and transient ischemic attacks)
- Diabetes mellitus (Type 1 or 2)
- Cancer/malignancy other than nonmelanoma skin cancer
- Primary renal disease
- Serum creatinine > 1.5 mg/dL in men or > 1.4 mg/dL in women
- Severe anemia
- Liver enzymes > 2.5 times 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, cyclooxygenase-2 inhibitors (COX2-I), 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: Vitamin methyl B12, St. Johns Wort, feverfew, black and white mustard seeds, wolf berry seed
- Severe Sleep apnea
- Night work
- Women who are pregnant, breast feeding, attempting conception, or planning to attempt conception over the next 6 months.
Data sourced from ClinicalTrials.gov (NCT01114373). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.