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

Sponsor

Russian Academy of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT00467805

Collaborator

(none)

Enrollment

Location

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Healthy	Procedure: Light therapy	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Basic Science

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

May 1, 2009

Actual Study Completion Date :

Oct 1, 2009

Outcome Measures

Primary Outcome Measures

Reproductive hormones concentration [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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