Methylselenocysteine Effects on Circadian Rhythm

NCT ID: NCT01611038

Last Updated: 2017-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2015-06-30

Brief Summary

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The primary objective of this study is to determine if vitamin supplementation with a naturally occurring dietary amino acid called organic selenium (i.e., methylselenocysteine) can restore disruption of circadian rhythm in shift workers.

Detailed Description

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All living cells have a circadian (daily) rhythm which controls a variety of bodily functions that change throughout the day, including body temperature, sleep, hunger, activity, hormone levels, etc. The circadian rhythm of the body is controlled by the amount of light that enters our eyes, so on our planet the length of the rhythm is 24 hours long. It is therefore reasonable to suspect that upsetting the timing of the rhythm would lead to changes in body function (as commonly experienced in "jet lag") and that prolonged changes might even lead to alterations in bodily functions and contribute to disease. This suggests that people whose service to the community that requires that they often work at night (nurses, doctors, police, hospital staff, firefighters, airline crews, factory workers, etc), might be at elevated risk of developing diseases. Studies have shown that women who do shift work have an elevated risk of breast cancer, probably as a result of altered hormone levels and cycling. Other studies have shown that vitamin supplementation with a naturally occurring dietary amino acid called organic selenium (i.e., methylselenocysteine) can restore this disrupted rhythm and possibly decrease this disease risk. Thus, the purpose of this study is to investigate whether taking daily selenium (i.e., methylselenocysteine) will restore the disrupted circadian rhythm in shift workers.

Conditions

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Breast Cancer Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Placebo given daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo capsule given daily

Methylselenocysteine

Methylselenocysteine given daily

Group Type EXPERIMENTAL

Methylselenocysteine

Intervention Type DIETARY_SUPPLEMENT

Methylselenocysteine capsule given daily

Interventions

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Methylselenocysteine

Methylselenocysteine capsule given daily

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo capsule given daily

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Permanent night shift schedule

Exclusion Criteria

* Nutritional supplements that contain selenium
* Pregnant
* Breast feeding
* Heart conditions
* Chronic lung disease
* Cancer therapy (current or past)
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rutgers, The State University of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Howard M. Kipen, MD, MPH

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Howard M. Kipen, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Helmut Zarbl, MD

Role: STUDY_CHAIR

Rutgers, The State University of New Jersey

Locations

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Environmental and Occupational Health Sciences Institute

Piscataway, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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0220100243

Identifier Type: -

Identifier Source: org_study_id

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