Effects of Vitamin B12 on the Body's Internal Clock

Sleep Disorders, Circadian Rhythm Clinical Trial

Official title:

Effect of Vitamin B12 on the Human Circadian Pacemaker

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00120484
• Other study ID #: R21AT002571
• Secondary ID: R21AT002571
• Status: Completed
• Phase: N/A
• First received: July 13, 2005
• Last updated: January 12, 2010
• Start date: April 2005
• Est. completion date: January 2008

Study information

• Verified date: January 2010
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parasomnias
• Sleep Disorders
• Sleep Disorders, Circadian Rhythm

Intervention

Drug:
• Vitamin B12

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital, Harvard Medical School	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in circadian period		first 2 weeks vs. final 2 weeks of period assessments	No