The key objective of the pilot study is to test the effectiveness of a desk-based lighting intervention to sustain 25(OH)D levels of office workers during autumn/winter months. The secondary objective is to explore the correlations between changes…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
VIT D insufficiency and general wellbeing by bringing the benefits of natural daylight inside (i.e. ultra small dose UV-B for VIT D)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the difference in 25(OH)D serum levels.
Secondary outcome
self reported indicators of sleep timing, sleep quality and general levels of
fatigue.
Background summary
Vitamin D3 is essential for people*s general health. Sunlight, through its UVB
irradiance, delivers the most efficient route to sufficient vitamin D3 levels.
Unfortunately, the modern lifestyles in urban and often indoor environments
lead to a lack of UV exposure in the natural way. Moreover, it is not possible
to create sufficient vitamin D in the skin during the autumn and winter months,
while vitamin D intake via food is not sufficient. Therefore, supplementation
with artificial UVB light seems an unobtrusive solution. This study explores
whether addition of artificial low and safe doses of UVB to LED lighting
solutions is sufficient to maintain healthy vitamin D3 levels for office
workers. We hypothesize that the participants exposed to ultra-low doses of UVB
during office hours will demonstrate a less rapid decline in 25(OH)D levels
than the control group without UVB supplementation.
Study objective
The key objective of the pilot study is to test the effectiveness of a
desk-based lighting intervention to sustain 25(OH)D levels of office workers
during autumn/winter months. The secondary objective is to explore the
correlations between changes in serum 25(OH)D and indicators of sleep timing,
sleep quality and general levels of fatigue.
Study design
This 8-week pilot study involves 28 office workers in which type of lighting is
manipulated between subjects (low-dose UVB light exposure vs. no artificial UVB
exposure). Randomization will be conducted in case of sufficient eligible
participants. Vitamin D blood levels and participants* self-reports on fatigue
and sleep timing and quality be conducted three times, with 4-week intervals,
supplemented with extremely short daily diaries (i.e., desk presence, time
spent outside and body exposure surface).
Intervention
The individual workspaces of 14 office workers will be equipped with the
desk-based intervention light and subsequently be exposed to a low dose of
artificial UVB during daytime hours with a maximum of 8 hours and 20 min (<0.5
SED, UVI =~0.06 under normal application conditions). The other 14 office
workers will act as the control group.
Study burden and risks
The main burden for participation in the study will be the discomfort
experienced during blood sampling and the time consumption associated with the
blood sampling and completing the questionnaires on sleep timing and quality,
and general fatigue (~ 10 min. per long questionnaire and less than 1 minute
per daily diary probing desk presence and time spent outside). The frequency of
the blood sampling and completing the long questionnaire is three times during
eight weeks with an estimated time consumption of 10 minutes per questionnaire
and 10 minutes for each blood sampling. Risk assessment in relation to the
ultra-low doses UVB indicated that the potential risk associated with
photobiological safety are mitigated to negligible/tolerable residual risk.
High Tech Campus 7
Eindhoven 5656 AE
NL
High Tech Campus 7
Eindhoven 5656 AE
NL
Listed location countries
Age
Inclusion criteria
* Age over 18 years old
* Fitzpatrick skin type II or III
* Desk presence of at least 2,5 days per week during the 8 weeks study period
or at least 4 days present in the office.
* Medically fit to work the hours as contractually agreed
Exclusion criteria
* * Current pregnancy, breast feeding or a desire to become pregnant
* Office workers with malignant skin conditions in the past or currently
* Photosensitive medical conditions or photo-sensitising drugs
* Users of medicines and/or cremes mentioning in the prescription as side
effect extra sensitivity to the sun
* Planned use of sun beds, or sunbed use during the past 4 weeks
* Currently taking or planning to take oral vitamin D3 supplements or have been
taking D3 supplements during the past 4 weeks.
* High vitamin D levels at the start of the study (>375 nmol/L) which need
medical attention
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL72938.015.20 |