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Methylselenocysteine Effects on Circadian Rhythm

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ClinicalTrials.gov Identifier: NCT01611038
Recruitment Status : Completed
First Posted : June 4, 2012
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
Howard M. Kipen, MD, MPH, Rutgers, The State University of New Jersey

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Prostate Cancer Dietary Supplement: Methylselenocysteine Dietary Supplement: Placebo Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Chemoprevention of Breast and Prostate Cancers in Shift Workers by Dietary Methylselenocysteine: Effects on Circadian Rhythm and Estrogen Receptor-B Cycling
Study Start Date : October 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo given daily
Dietary Supplement: Placebo
Placebo capsule given daily

Experimental: Methylselenocysteine
Methylselenocysteine given daily
Dietary Supplement: Methylselenocysteine
Methylselenocysteine capsule given daily




Primary Outcome Measures :
  1. Determine if selenium (i.e., methylselenocysteine) supplementation can restore disruption of circadian rhythm and estrogen receptor-B levels in shift workers [ Time Frame: 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01611038


Locations
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United States, New Jersey
Environmental and Occupational Health Sciences Institute
Piscataway, New Jersey, United States, 08854
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
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Principal Investigator: Howard M. Kipen, MD, MPH Rutgers, The State University of New Jersey
Study Chair: Helmut Zarbl, MD Rutgers, The State University of New Jersey
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Responsible Party: Howard M. Kipen, MD, MPH, Professor, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01611038    
Other Study ID Numbers: 0220100243
First Posted: June 4, 2012    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Selenomethylselenocysteine
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents