An interventional study of melatonin in Prehypertension and Healthy, sponsored by Thomas Jefferson University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-08.
Sponsored by Thomas Jefferson University · Not applicable, Interventional, and Prevention
The investigators will be studying the effect of melatonin on blood pressure, insulin resistance, and platelets, along with possible reasons for how melatonin cases these effects.
The investigators will be studying the effect of melatonin on blood pressure and insulin resistance, and possible reasons for how melatonin works on blood pressure and IR. Along with blood testing to measure adipokines, insulin resistance (IR), and platelet function (how well your blood clots), 24-hour ambulatory blood pressure monitoring (ABPM) will be used to measure blood pressure, since ABPM is the gold standard (best method) for accurate assessment of blood pressure status and associated cardiovascular risk. Vascular (blood vessel) function, IR, adipokine levels and sleep quality will also be measured. All study endpoints will be measured at baseline and following 6 weeks of daily melatonin 9 mg dosing.
145 studies on the registry are indexed under Prehypertension; 21 are open to participants now.
This study's enrollment of 31 is below the median of 62 across 127 interventional studies indexed under Prehypertension.
Browse Prehypertension studies →Thomas Jefferson University is the lead sponsor of 384 studies on the registry; 71 are open to participants now.
Of its 44 completed or terminated interventional studies of FDA-regulated products, 20 (45%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients with a diagnosis of
patients ages 18-45, taking melatonin
Dietary Supplement: melatonin
patients ages 18-45, usual care
patients ages 60 and older, taking melatonin
Dietary Supplement: melatonin
patients ages 60 and older, usual care
controlled release, 9 mg taken 30 minutes before bedtime x 6 weeks
Also known as: Life Extension Foundation
Office Systolic Blood pressure change
Change in Systolic blood pressure measured in the office at 6 weeks
Time frame: Baseline to 6 weeks
Office Diastolic Blood pressure change
Change in Diastolic blood pressure measured in the office at 6 weeks
Time frame: Baseline to 6 weeks
Ambulatory Systolic Blood pressure change
Change in 24 hour average Systolic blood pressure at 6 weeks
Time frame: Baseline to 6 weeks
Ambulatory Diastolic Blood pressure change
Change in 24 hour average Diastolic blood pressure at 6 weeks
Time frame: Baseline to 6 weeks
HOMA: Homeostasis Model Assessment change
Insulin sensitivity measure change at 6 weeks
Time frame: Baseline to 6 weeks
QUICKI: Quantitative insulin sensitivity check index change
Insulin sensitivity measure change at 6 weeks
Time frame: Baseline to 6 weeks
Arachidonic acid stimulated aggregation change
Platelet activity measure change at 6 weeks
Time frame: Baseline to 6 weeks
Plan to share: Yes — Summarized data, available immediately by contacting PI
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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Thomas Jefferson University