Effectivity of using a low-dose UVB lighting solution to maintain healthy vitamin D levels
| ISRCTN | ISRCTN47902923 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47902923 |
| Secondary identifying numbers | W20.113 |
- Submission date
- 03/12/2021
- Registration date
- 03/12/2021
- Last edited
- 20/09/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
The key objective of this study is to test the effectiveness of a home office lighting solution using low-dose ultraviolet light (UVB) exposure to sustain vitamin D levels of office workers during the winter months. The secondary objective is to explore the correlations between changes in serum vitamin D and indicators of sleep timing, sleep quality, and general levels of fatigue.
Who can participate?
Desk-based office workers, working from home (during COVID-19 restrictions)
What does the study involve?
The study was conducted in the home office of participants. Participants will be allocated to one of two groups, with an equal chance of being in either group (like tossing a coin) where possible. One group will have a desk lamp installed to provide exposure to very low-intensity ultraviolet light spread over 8 hours a day for 8 weeks and the other group will not be provided with additional ultraviolet light exposure. Vitamin D levels will be measured via blood sampling at the start of the study, at 4 weeks, and at 8 weeks. Participants will be asked to complete questionnaires about sleep timing, quality, and fatigue at the same times as the blood samples. Daily questionnaires will also be used to record time spent outside, sunlight exposure duration, and the surface exposed to sunlight.
What are the possible benefits and risks of participating?
There are no specific benefits nor any risks of participating.
Where is the study run from?
Signify (Netherlands).
When is the study starting and how long is it expected to run for?
From October 2020 to March 2021
Who is funding the study?
Signify (Netherlands)
Who is the main contact?
Bianca van der Zande, Biekzand23@icloud.com
Contact information
Scientific
Atlas 9.401
P.O. Box 513
Eindhoven
5600 MB
Netherlands
 ORCID ID |
0000-0001-8794-0852 |
|---|---|
| Phone | +31649818740 |
| laura_huiberts@live.nl |
Scientific
Atlas 9.401
P.O. Box 513
Eindhoven
5600 MB
Netherlands
| ORCID ID |
0000-0002-8127-397X |
|---|---|
| Phone | +31 40 247 5754 |
| Y.A.W.d.Kort@tue.nl |
Study information
| Study design | Partly-randomized controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Partly randomised |
| Study setting(s) | Home |
| Study type | Prevention |
| Participant information sheet | 40755_PIS_Dutch.pdf |
| Scientific title | Using a Low-dose UVB Lighting Solution During Working Hours: An Explorative Investigation Towards the Effectivity in Maintaining Healthy Vitamin D Levels |
| Study hypothesis | 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 during the eight-week study period (January to March) than the control group without UVB supplementation. |
| Ethics approval(s) | Approved 26/10/2020, Máxima Medisch Centrum, Veldhoven (METC Máxima MC, Postbus 7777. 5500 MB Veldhoven, De Run 4600, 5504 DB Veldhoven, The Netherlands; +31408889528; metc@mmc.nl), ref: W20.113 |
| Condition | Vitamin D deficiency |
| Intervention | Participants were allocated randomly to the two study conditions as much as possible. This was, however, not possible for several participants as they either changed in their work location or amount of working hours at home before or during the study, or because they did not have grounded electricity outlets in their houses needed for the installation of the lamp. To this end, 9 participants were allocated to the control group before randomization. All participants were recruited by an independent recruitment organization to ensure independence of the research team. The study was performed in participants’ home offices as COVID-19 regulations asked people to work from home during the study period (January 2021 to March 2021 in The Netherlands). For participants in the intervention group, a lamp was installed at the home office before the start of the study. In the visual wavelength range, the lamp provided an illuminance of about 1100 lx (~ 3700 K) at 20 cm distance and about 100 lx at 80 cm distance. Additionally, the lamp emitted a continuous ultra-low and safe artificial actinic UV irradiance of less than 3.0 mW/m² at 20 cm distance and 0.77 mW/m² at 80 cm distance. This resulted in an estimated maximal received dose of ~0.3 SED (UVI = 0.04) per 8 h workday when seated at the desk. Participants in the intervention group and members of their household were advised to respect the indicated minimum application distance (80 cm). This distance keeps the actinic UV exposure within Risk Group Exempt limits, which allows for a continuous exposure of 30000 sec per day (8 h and 20 min) according to the IEC62471. The UVB irradiance stability was checked by a before and after actinic UVB measurement at the Lighting Test Center Europe, Eindhoven. The equipment used for these measurements consisted of a Cary 17d monochromator and a Keithley 2000 multimeter. The scanned spectral range was 200-800 nm and measurements were executed at 80 cm distance. The averaged actinic UV weighted UVB irradiance before and after were respectively 0.76 mWA/m² (SD = 0.04 mWA/m²) and 0.75 mWA/m² (SD = 0.07 mWA/m²). The stability was realized by an adjustment of the DALI settings at the end of Week 4 to correct for the slow decline in UV intensity due to the lifetime degradation of the used UVB LEDs. Participants in the control group did not receive a lamp in their home office and were therefore not exposed to extra UVB. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Standing lamp with a continuous ultra-low and safe artificial actinic UV irradiance of less than 3.0 mWA/m2 at 20 cm distance and 0.77 mWA/m2 at 80 cm distance. |
| Primary outcome measure | Serum 25(OH)D level measured using blood sampling and automated immunoassay at baseline, 4, and 8 weeks |
| Secondary outcome measures | Sleep duration, midsleep timing, sleep quality, and fatigue measured using participant questionnaire at baseline, 4, and 8 weeks |
| Overall study start date | 26/10/2020 |
| Overall study end date | 12/03/2021 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 28 |
| Total final enrolment | 28 |
| Participant inclusion criteria | 1. Aged ≥18 years 2. Fitzpatrick skin type II or III 3. Living in/around Eindhoven 4. Medically fit to work the hours as contractually agreed 5. Desk presence (at the home office) of at least 2.5 days per week during the 8 weeks study 6. Finding it no problem to have blood drawn three times over a period of 8 weeks |
| Participant exclusion criteria | 1. Current pregnancy, breast feeding or a desire to become pregnant 2. Having children at home aged 10 years or younger 3. Having malignant skin conditions in the past or currently 4. Photosensitive medical conditions or photo-sensitising drugs 5. Users of medicines and/or crèmes mentioning in the prescription as side effect extra sensitivity to the sun/interaction with sun exposure 6. Planned use of sun beds, or sunbed use during the past 4 weeks 7. Currently taking or planning to take oral vitamin D3 supplements or have been taking D3 supplements during the past 4 weeks 8. High vitamin D levels at the start of the study (>375 nmol/l) which need medical attention |
| Recruitment start date | 23/11/2020 |
| Recruitment end date | 18/12/2020 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
P.O. Box 513
Eindhoven
5600 MB
Netherlands
Sponsor information
Industry
High Tech Campus 7
Eindhoven
5656 AE
Netherlands
| Phone | +31615243508 |
|---|---|
| Bianca.van.der.zande@signify.com | |
| Website | https://www.signify.com/ |
"ROR" |
https://ror.org/0532vdr17 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/03/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Planned to publish the study in PLOS ONE. |
| IPD sharing plan | Data cannot be shared publicly because of the informed consent form stating that data will only be available to others in an encrypted and password protected institutional online data repository. Data are available upon request via the OSF project page through which requests can be sent to the authors (https://osf.io/qnk26/) or via the institutional Ethics Committee (contact via ethicalreviewboardHTI@tue.nl). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Dutch language | 03/12/2021 | No | Yes | |
| Protocol file | version 3.0 | 26/10/2020 | 03/12/2021 | No | No |
| Results article | 31/03/2023 | 03/04/2023 | Yes | No |
Additional files
- 40755_PIS_Dutch.pdf
- Dutch language
- 40755_Protocol_v3.0_26Oct20.pdf
Editorial Notes
20/09/2023: The following changes were made:
1. Drug/device/biological/vaccine name(s) was added.
2. The intention to publish date was changed from 12/03/2022 to 31/03/2023.
03/04/2023: Publication reference added.
08/12/2021: Internal review.
03/12/2021: Trial’s existence confirmed by Máxima Medisch Centrum METC.
