Effects of Vitamin B12 on the Body's Internal Clock

What Was Tested

The trial (not phased) is built around Cyanocobalamin (Vitamin B12).

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.

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

The registry lists 10 actual participants took part.

It was open to people of any sex aged from 18 years up to 30 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Diagnosis of delayed sleep phase syndrome OR self-described as a "night owl".

The full record lists 1 inclusion and 7 exclusion criteria; among the exclusions: history of medical illness; history of psychiatric illness in participant or his or her family members; current medication or vitamin use.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

Because people in this Cyanocobalamin (Vitamin B12) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Cyanocobalamin (Vitamin B12) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2005-04 with completion listed for 2007-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in circadian period (time frame: first 2 weeks vs. final 2 weeks of period assessments).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 10 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.