Effects of Vitamin B12 on the Body's Internal Clock

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00120484
First received: July 13, 2005
Last updated: January 12, 2010
Last verified: January 2010
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Vitamin B12 on the Human Circadian Pacemaker

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Change in circadian period [ Time Frame: first 2 weeks vs. final 2 weeks of period assessments ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: April 2005
Study Completion Date: January 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00120484

Locations
United States, Massachusetts
Brigham and Women's Hospital, Harvard Medical School
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Jeanne F. Duffy, PhD Brigham and Women's Hospital, Harvard Medical School
  More Information

No publications provided

Responsible Party: Jeanne F. Duffy, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00120484     History of Changes
Other Study ID Numbers: R21 AT002571, R21AT002571
Study First Received: July 13, 2005
Last Updated: January 12, 2010
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Brigham and Women's Hospital:
Circadian Rhythm
Biological Clock
Complementary and Alternative Medicine

Additional relevant MeSH terms:
Sleep Disorders, Circadian Rhythm
Sleep Disorders
Parasomnias
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Chronobiology Disorders
Dyssomnias
Occupational Diseases
Vitamin B 12
Hydroxocobalamin
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014