Official Title: “Effect of Vitamin B12 on the Human Circadian Pacemaker”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Bio-equivalence Study

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.

Intervention(s) in this Clinical Trial

• Drug: Vitamin B12

Primary Measures

• Change in circadian period

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 30 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: National Center for Complementary and Alternative Medicine (NCCAM)

Overall Clinical Trial Officials and Contacts

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

Overall Contact: Jennifer Row 617-732-8572 vitamin@rics.bwh.harvard.edu

Information obtained from ClinicalTrials.gov on October 15, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00120484

Study ID Number: R21 AT002571

ClinicalTrials.gov Identifier: NCT00120484

Health Authority: United States: Federal Government