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Effects of Vitamin B12 on the Body's Internal Clock

Primary Purpose

Sleep Disorders, Circadian Rhythm

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin B12
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disorders, Circadian Rhythm focused on measuring Circadian Rhythm, Biological Clock, Complementary and Alternative Medicine

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Brigham and Women's Hospital, Harvard Medical School

Outcomes

Primary Outcome Measures

Change in circadian period

Secondary Outcome Measures

Full Information

First Posted
July 13, 2005
Last Updated
January 12, 2010
Sponsor
Brigham and Women's Hospital
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00120484
Brief Title
Effects of Vitamin B12 on the Body's Internal Clock
Official Title
Effect of Vitamin B12 on the Human Circadian Pacemaker
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Brigham and Women's Hospital
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorders, Circadian Rhythm
Keywords
Circadian Rhythm, Biological Clock, Complementary and Alternative Medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Vitamin B12
Primary Outcome Measure Information:
Title
Change in circadian period
Time Frame
first 2 weeks vs. final 2 weeks of period assessments

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeanne F. Duffy, PhD
Organizational Affiliation
Brigham and Women's Hospital, Harvard Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital, Harvard Medical School
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

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Effects of Vitamin B12 on the Body's Internal Clock

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