NCT00120484

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 18, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

January 14, 2010

Status Verified

January 1, 2010

Enrollment Period

2.7 years

First QC Date

July 13, 2005

Last Update Submit

January 12, 2010

Conditions

Sleep Disorders, Circadian Rhythm

Keywords

Circadian RhythmBiological ClockComplementary and Alternative Medicine

Outcome Measures

Primary Outcomes (1)

  • Change in circadian period

    first 2 weeks vs. final 2 weeks of period assessments

Interventions

Vitamin B12DRUG

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of delayed sleep phase syndrome OR self-described as a "night owl"

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital, Harvard Medical School

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm

Interventions

Vitamin B 12

Condition Hierarchy (Ancestors)

Chronobiology DisordersNervous System DiseasesDyssomniasSleep Wake DisordersOccupational DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

CorrinoidsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Jeanne F. Duffy, PhD

    Brigham and Women's Hospital, Harvard Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 13, 2005

First Posted

July 18, 2005

Study Start

April 1, 2005

Primary Completion

December 1, 2007

Study Completion

January 1, 2008

Last Updated

January 14, 2010

Record last verified: 2010-01

Locations

US(1)