Comparing the additional effects of UVB irradiation to oral vitamin D supplementation on well-being and quality of life in psycho-geriatric nursing home residents.
ID
Source
Brief title
Condition
- Other condition
- Vitamin related disorders
Synonym
Health condition
kwaliteit van leven
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Well-being and quality of life will be measured by 2 scales: the CMAI ( Cohen -
Mansfield Agitation Inventory) and the Cornell scale for depression in
dementia and will be taken at T0,1,2 (at 0,2 and 6 months)
Secondary outcome
Vitamin D status:25(OH)D serum levels will be taken at T0,1,2 (at 0,2 and 6
months)
Other biochemical parameters of calcium homeostasis: serum levels of calcium,
alkaline phosphatase, phosphate and parathyroid hormone (PTH) will be taken at
T0 and T2
Background summary
Vitamin D deficiency [25-hydroxyvitamin D (25(OH)D) < 25 nmol/l] and vitamin D
insufficiency [25(OH)D) < 50nmol/l] is common in older people, in particular in
nursing home residents. Vitamin D deficiency causes secondary
hyperparathyroidism, which leads to cortical bone loss. It may also lead to
fatigue, muscle weakness and falls. Vitamin D deficiency thus contributes to
the pathogenesis of osteoporosis and fractures.
Vitamin D receptors, however can be found in many other tissues and vitamin D
deficiency is associated with multiple other health problems such as increased
risk of common cancer, autoimmune and cardiovascular diseases, cognitive
impairment and depression. In older people, vitamin D supplementation by UVB
irradiation may be preferable to oral supplementation: it can not cause toxic
levels, it is cheap and easy and it helps in preventing polypharmacy. Moreover
there are indications that UVB exposure has beneficial effects on health and
well-being by other mechanisms than the vitamin D -pathway alone. In a pilot,
prior to this study, it was shown that the older skin is very well capable of
producing vitamin D: in this study weekly frontal half body irradiation with
UVB, at 0,5 MED (minimal erythema dose), during 8 weeks, led to an important
increase in serum vitamin D levels.
Study objective
Comparing the additional effects of UVB irradiation to oral vitamin D
supplementation on well-being and quality of life in psycho-geriatric nursing
home residents.
Study design
Randomized trial on the effect of UVB irradiation compared with oral vitamin D
supplementation on well-being, quality of life and vitamin D serum levels in
psychogeriatric nursing home residents in the Netherlands.
Intervention
Oral vitamin D supplementation (5600 IU/week) or UVB irradiation 2x/week (1,0
SED (standard erythema dose)=1 CIE dose (Comite International de l'Eclairage)
of 100 J/m² which is comparable with 50 % of the MED (minimal erythema dose) of
a person with skin type II (pale skin, blond hair, light eyes). For practical
reasons, in all participants the (safe) time of UVB irradiation will be the
same.
Participants get de UVB irradiation while they lie on their bed with their eyes
protected. A Hapro ® sunbed is used which is placed at a fixed distance above
the bed. Before use sunbeds will be tested, measured and inspected by the
Department of dermatology of the Leiden University Medical Center.
Well-being and quality of life will be measured by 2 scales: the CMAI ( Cohen -
Mansfield Agitation Inventory) and the Cornell scale for depression in
dementia.
The severity of dementia will be determined with the BANS-S (Bedford Alzheimer
Nursing Severity Scale)
Study burden and risks
none
Hippocratespad 21
Leiden 2333 ZD
NL
Hippocratespad 21
Leiden 2333 ZD
NL
Listed location countries
Age
Inclusion criteria
nursing home residents, 70 years or above
Exclusion criteria
-contraindications against ultraviolet irradiation: actinic damaged skin including skin cancer, sun allergy, porphyria
-contraindications to treatment with vitamin D: hypercalciaemie and sarcoidosis
-the use of food supplementation with vitamin D
-known agitation, aggression or resistance to physical contact (blood tests)
Design
Recruitment
Medical products/devices used
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 | NL55586.058.15 |