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Melatonin and Nighttime Blood Pressure in African Americans-8 mg Study

NCT01114360 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2015-12-18

Study results available
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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.

Conditions

Interventions

DRUG

Melatonin

Melatonin (N-acetyl-5-methoxytryptamine) is an indoleamine compound. Subjects will receive 8 mg time-release melatonin pills, orally, once per night for 4 weeks.

DRUG

Placebo

Subjects received placebo pills (3 pills of 8 mg each) to be taken orally once per night for 4 weeks.

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • Frederic F Rahbari Oskoui, MD, MSCR · Emory University

  • Arlene Chapman, M.D. · Emory University

  • Donald Bliwise, Ph.D. · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2013-09-30
Completion
2014-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01114360 on ClinicalTrials.gov