Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2005-04-30
2008-01-31
Brief Summary
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Detailed Description
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This study will last 47 days. Participants will undergo a 3-week medical and psychological screening prior to study entry. Eligible participants will be admitted to the General Clinical Research Center where they will live in a private study room for the duration of the study. The room will be a time-free environment with no windows, clocks, television, or radio. Participants will not be able to make or receive telephone calls, and their bedtimes, wake times, and mealtimes will be determined by study researchers. Participants will be randomly assigned to receive three capsules of either vitamin B12 or placebo daily. Blood and saliva collection will occur daily to determine core body temperature and hormone levels. Performance tests to determine participants' cognitive abilities will be administered at regular intervals throughout each day. Participants' sleep will be recorded every night with polysomnography, which will monitor brain and muscle activity and breathing patterns during sleep.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Interventions
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Vitamin B12
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* History of psychiatric illness in participant or his or her family members
* Current medication or vitamin use
* Follow a vegan diet
* Significant visual problem
* Recent travel across time zones
* History of rotating shiftwork
18 Years
30 Years
ALL
Yes
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
Brigham and Women's Hospital
OTHER
Responsible Party
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Brigham and Women's Hospital
Principal Investigators
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Jeanne F. Duffy, PhD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital, Harvard Medical School
Locations
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Brigham and Women's Hospital, Harvard Medical School
Boston, Massachusetts, United States
Countries
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Other Identifiers
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