Immediate Effect of Light on Reproductive Hormones in Women: a Role of the Spectrum

This study has been completed.
Sponsor:
Information provided by:
Russian Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00467805
First received: April 30, 2007
Last updated: April 8, 2010
Last verified: October 2009
  Purpose

The study investigates an acute effect of white-appearing LED light (with a peak in blue portion) vs. red LED light of similar irradiance on reproductive hormones in healthy women.


Condition Intervention
Healthy
Procedure: Light therapy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science

Further study details as provided by Russian Academy of Medical Sciences:

Primary Outcome Measures:
  • Reproductive hormones concentration [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: March 2009
Study Completion Date: October 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Detailed Description:

Sixteen healthy women came to the laboratory at 7:30 (wearing dark goggles) at two occasions (separated by 2-3 days, first time - at the 3rd-8th day of their menstrual cycle) to be exposed for 45' to white-appearing or red LED light (sequential allocation). The white light has a distinct peak at 460 nm, the narrow-band red light peaked at 651 nm. The LED devices were positioned at the distance of 50 cm (white) and 45 cm (red) from the eyes to be matched by irradiance (approximately 7.0 microWt/m2); background light in direction of gaze was 5-10 lux. Blood and saliva samples were collected before, in the middle, and during the last minutes of the 45' exposure to be measured later for concentration of luteinizing hormone, follicle-stimulating hormone, prolactin, estrogen, progesterone, and also - for cortisol and melatonin (the last one - in saliva) as well-studied indicators of the direct effect of light.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 18-45 y
  • normal (21-35 days) menstrual cycle
  • good and stable general health
  • normal body weight index 18.5-29.9
  • normal sleep-wake regimen
  • living close to the laboratory (<7' by walk)
  • "good"cubital veins

Exclusion Criteria:

  • difficulty to contact
  • travel over several time zones during last month
  • medications known to interfere with hormone release
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00467805

Locations
Russian Federation
Institute of Internal Medicine SB RAMS
Novosibirsk, Russian Federation, 630089
Sponsors and Collaborators
Russian Academy of Medical Sciences
Investigators
Study Chair: Konstantin V Danilenko, MD Institute of Internal Medicine SB RAMS
Principal Investigator: Oksana Y. Sergeeva, PhD student Institute of Internal Medicine SB RAMS
  More Information

No publications provided

Responsible Party: Outside In
ClinicalTrials.gov Identifier: NCT00467805     History of Changes
Other Study ID Numbers: M-s4c
Study First Received: April 30, 2007
Last Updated: April 8, 2010
Health Authority: Russia: Ethics Committee

Keywords provided by Russian Academy of Medical Sciences:
Light exposure
light spectrum
reproductive hormones
women

ClinicalTrials.gov processed this record on July 22, 2014