Circadian rhythms are 24-hour cycles that influence natural functions in the body such as heart rate, blood pressure, and body temperature. Circadian rhythms provide the body with an internal clock and affect sleep patterns. The purpose of this study is to determine the effects of vitamin B12 supplements on circadian rhythms and sleep-wake regulation.

Condition	Intervention
Sleep Disorders, Circadian Rhythm	Drug: Vitamin B12

Further Study Details: 

Primary Outcomes: Change in circadian period
Expected Total Enrollment:  10

Individuals with circadian rhythm sleep disorder suffer from recurrent patterns of disrupted sleep that can significantly affect their daily functioning. Evidence suggests that vitamin B12 supplements may have a beneficial effect on sleep patterns. However, research on the effects of vitamin B12 supplements on sleep is limited. This study will determine the effects of vitamin B12 supplements on circadian rhythms and sleep-wake regulation.

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.

Ages Eligible for Study:  18 Years   -   30 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• Diagnosis of delayed sleep phase syndrome OR self-described as a "night owl"

Exclusion Criteria:

• History of medical illness
• 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00120484

Deirdre McCarthy      617-732-7342    dmccarthy@rics.bwh.harvard.edu

Massachusetts
      Brigham and Women''''s Hospital, Harvard Medical School, Boston,  Massachusetts,  02115,  United States; Recruiting

Study chairs or principal investigators

Jeanne F. Duffy, PhD,  Principal Investigator,  Brigham and Women''''s Hospital, Harvard Medical School   

Study ID Numbers:  R21AT002571
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 15, 2005
ClinicalTrials.gov Identifier:  NCT00120484
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-07-26