Phase 2
Completed N=37
Melatonin and Nighttime Blood Pressure in African Americans-8 mg Study
Source: ClinicalTrials.gov NCT01114360 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcomePrimary: Mean Nighttime Systolic Blood Pressure (SBP) — 126.6; 125.3 mmHg — p=0.075
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Nighttime Systolic Blood Pressure (SBP) |
126.6; 125.3 | 0.075 |
| PRIMARY Mean Nighttime Diastolic Blood Pressure (DBP) |
76; 76.2 | 0.75 |
| SECONDARY Mean Nighttime Mean Arterial Pressure (MAP) |
92.9; 92.6 | 0.79 |
| SECONDARY Mean Nighttime Heart Rate (HR) |
75.4; 76.2 | 0.21 |
| SECONDARY Mean Daytime Systolic Blood Pressure (SBP) |
135.13; 133.9 | 0.64 |
| SECONDARY Mean Daytime Diastolic Blood Pressure (DBP) |
85.7; 86.2 | 0.89 |
| SECONDARY Mean Daytime Mean Arterial Pressure (MAP) |
102.2; 102.1 | 0.97 |
| SECONDARY Mean Daytime Heart Rate (HR) |
81; 84.6 | 0.01 sig |
| SECONDARY Urinary Dopamine Excretion Rate |
140.9; 137.8 | 0.71 |
| SECONDARY Urinary Noradrenaline Excretion Rate |
17.5; 19.0 | 0.38 |
| SECONDARY Urinary Adrenaline Excretion Rate |
2.75; 2.02 | 0.11 |
| SECONDARY Plasma E-Selectin |
38.6; 38.9 | 0.96 |
| SECONDARY Plasma P-Selectin |
97.02; 82.7 | 0.25 |
| SECONDARY Total Sleep Time |
399.8; 412.2 | 0.52 |
| SECONDARY Nocturnal Dipping of Blood Pressure |
5.6; 6.14 | — |
| SECONDARY Percentage of Participants With Melatonin-related Side Effect. |
47.2; 50 | — |
Eligibility Criteria
Inclusion Criteria
- Males or females ages 18 to 64
- Prior history of elevated nighttime blood pressure (BP) ((systolic blood pressure (SBP) >115 mmHg))
- 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 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 > 1.4mg/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 or 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
- 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 (NCT01114360). 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.