NCT01611038

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Oct 2011

Typical duration for not_applicable breast-cancer

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

October 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 4, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

September 12, 2017

Status Verified

September 1, 2017

Enrollment Period

1.8 years

First QC Date

May 18, 2012

Last Update Submit

September 11, 2017

Conditions

Breast CancerProstate Cancer

Outcome Measures

Primary Outcomes (1)

  • Determine if selenium (i.e., methylselenocysteine) supplementation can restore disruption of circadian rhythm and estrogen receptor-B levels in shift workers

    30 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo given daily

Dietary Supplement: Placebo

Methylselenocysteine

EXPERIMENTAL

Methylselenocysteine given daily

Dietary Supplement: Methylselenocysteine

Interventions

MethylselenocysteineDIETARY_SUPPLEMENT

Methylselenocysteine capsule given daily

Methylselenocysteine
PlaceboDIETARY_SUPPLEMENT

Placebo capsule given daily

Placebo

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Permanent night shift schedule

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Environmental and Occupational Health Sciences Institute

Piscataway, New Jersey, 08854, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsProstatic Neoplasms

Interventions

selenomethylselenocysteine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Howard M. Kipen, MD, MPH

    Rutgers, The State University of New Jersey

    PRINCIPAL INVESTIGATOR

  • Helmut Zarbl, MD

    Rutgers, The State University of New Jersey

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 18, 2012

First Posted

June 4, 2012

Study Start

October 1, 2011

Primary Completion

July 1, 2013

Study Completion

June 1, 2015

Last Updated

September 12, 2017

Record last verified: 2017-09

Locations

US(1)