- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00120484
Effects of Vitamin B12 on the Body's Internal Clock
Effect of Vitamin B12 on the Human Circadian Pacemaker
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital, Harvard Medical School
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in circadian period
Time Frame: first 2 weeks vs. final 2 weeks of period assessments
|
first 2 weeks vs. final 2 weeks of period assessments
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jeanne F. Duffy, PhD, Brigham and Women's Hospital, Harvard Medical School
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21AT002571 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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