search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


The effect of UVB irradiation compared with oral vitamin D supplementation on well-being of psycho-geriatric nursing home redidents.


- candidate number24381
- NTR NumberNTR5857
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-mei-2016
- Secondary IDsP16.010 
- Public TitleThe effect of UVB irradiation compared with oral vitamin D supplementation on well-being of psycho-geriatric nursing home redidents.
- Scientific TitleThe effect of UVB irradiation compared with oral vitamin D supplementation on well-veing in psycho-geriatric nursing home residents in the Netherlands.
- ACRONYMVDUVB study
- hypothesisUVB irradiation has an additional effect on well-being compared to oral vitamin D-supplementation in psycho-geriatric nursing home residents.
- Healt Condition(s) or Problem(s) studiedVitamin D, Dementia, Older persons living in nursing homes
- Inclusion criteria > 70 years of age
- Exclusion criteria contraindications against ultraviolet radiation: actinic damaged skin including, skin cancer, sun allergy, porphyrias, use of drugs that can induce photodermatoses.
contraindications to treatment with vitamin D3 such as hypercalcemia and sarcoidosis
the use of vitamin D fortified supplementary feeding
in the context of the underlying dementia, frequent anxiety or fear or aggression and known resistance to physical contact (e.g. blood tests)
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2016
- planned closingdate
- Target number of participants80
- InterventionsThe intervention consists of half-body UVB irradiation, two times a week, over 6 months, with 0.5 minimal erythemal dose (MED), compared to oral supplementation with 5600 IE cholecalciferol once a week.
- Primary outcomeWell-being, monitored with the CMAI (Cohen-Mansfield Agitation Inventory) and the Cornell scale for depression in dementia at 0, 3 and 6 months.
- Secondary outcome Vitamin D status
Calcium homeostasis
- Timepointsbaseline (0 months), 3 and 6 months
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES B. Veleva
- CONTACT for SCIENTIFIC QUERIESDr. M.A.A. Caljouw
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
WoonZorgcentra Haaglanden (WZH), Den Haag, VDL Hapro, Kapelle
- Publications
- Brief summaryBackground: in older people, vitamin D supplementation by UVB irradiation may be preferable to oral supplementation: it cannot cause toxic levels; it is cheap and easy to apply and it helps in preventing polypharmacy. Moreover, there are indications that UVB exposure has additional beneficial effects on health and well-being by other mechanisms than the vitamin D-pathway alone. UVB irradiation has shown to be effective in increasing 25(OH)D serum levels in nursing home residents.

Objective: comparing the additional effects of UVB irradiation to oral vitamin D-supplementation on well-being in psycho-geriatric nursing home residents.

Method: A randomized controlled trial. Subjects are psycho-geriatric nursing home residents (N=80) admitted in two Dutch nursing homes. The intervention consists of half-body UVB irradiation, two times a week, over 6 months, with 0.5 minimal erythemal dose (MED), compared to oral supplementation with 5600 IE cholecalciferol once a week. Main outcome measure is Well-being, monitored by asking the nursing staff to complete the CMAI (Cohen-Mansfield Agitation Inventory) and the Cornell scale for depression in dementia at 0, 3 and 6 months.
- Main changes (audit trail)
- RECORD23-mei-2016 - 6-jul-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl