Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00120484
Status:
COMPLETED
Last Update Posted:
2010-01-14
First Post:
2005-07-13
Brief Title:
Effects of Vitamin B12 on the Bodys Internal Clock
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Effect of Vitamin B12 on the Human Circadian Pacemaker
Status:
COMPLETED
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21AT002571 | NIH | None | httpsreporternihgovquickSearchR21AT002571 |