- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04399291
Vitamin D Status and Bone Health of Older Adults in Care Facilities
21. maj 2020 opdateret af: University of Ulster
A Cross-sectional Analysis of Vitamin D Status and Bone Health of Older Adults Within Residential Care Facilities in Northern Ireland.
Vitamin D deficiency is proposed to be prevalent in community-dwelling older adults, with prevalence substantially higher among older adults in residential care facilities.
Musculoskeletal health is compromised in older vitamin D deficient individuals and alongside frailty, sarcopenia and osteoporosis associated with ageing, affected individuals are at increased risk of falls and fractures.
Vitamin D supplementation is an effective intervention for fall prevention and, along with calcium supplementation, in fracture risk reduction in institutionalised older adults.
Thus, monitoring vitamin D status and treating deficiency among older adults in residential care facilities may limit the substantial economic burden associated with falls/fractures in this population.
The vitamin D status of older adults in residential care facilities in Northern Ireland (NI) is currently unknown, therefore, the aim of this pilot study is to determine the vitamin D status of this cohort of the population, and to define factors which may influence vitamin D status, including body mass index (BMI), mobility out-of-doors, medication use, dementia and diet.
Vitamin D status will be determined via the measurement of 25-hydroxyvitamin D using liquid chromatography-tandem mass spectrometry (LC-MS/MS).
In addition, biomarkers associated with vitamin D metabolism will be measured including calcium, albumin, creatinine, urea, bone turnover markers and parathyroid hormone.
Factors that may affect vitamin D status will be assessed using a health and lifestyle questionnaire and dietary vitamin D intake will be estimated via analysis of the menus in the residential care facilities.
Vitamin D supplementation practices in these facilities will also be assessed via analysis of drug prescription records, focusing on differences between residents who have/have not suffered a fracture.
Physical measures such grip strength, timed up and go test and T-score measurement via Achilles ultrasound machine will be taken.
This study will provide data on the prevalence of vitamin D deficiency in older adults in residential care facilities within NI and identify factors that predispose residents to increased risk of deficiency.
Dissemination of these findings, along with analysis of current supplementation practices, will help practitioners to develop a strategy to identify those residents with vitamin D deficiency/insufficiency and thus requiring supplementation ultimately improving health and well-being.
This study will also inform the design of a larger study to investigate vitamin D status, supplementation and musculoskeletal health in older adults in residential care facilities within Northern Ireland, providing important information that will ultimately contribute towards reducing falls and fractures within this population.
Studieoversigt
Status
Suspenderet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Forventet)
200
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Co.Londonderry
-
Londonderry, Co.Londonderry, Det Forenede Kongerige
- Western Health and Social Care Trust Care Home facilities
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
65 år og ældre (Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Older adults within residential care facilities in the Western Health and Social Care Trust in Northern Ireland have been selected to be studied.
Residents are being investigated to determine vitamin D status and bone.
Beskrivelse
Inclusion Criteria:
- Currently residing (≥1 month) within a residential care facility in the Western Health and Social Care Trust in Northern Ireland
Exclusion Criteria:
- Participants will be excluded from the study if by the judgement of the consultant rheumatologist that they have very abnormal bone or vitamin D metabolism due to conditions such as end stage renal failure or bone metastases.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Tværsnit
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Residential care facility residents
Older adults recruited from care homes in Northern Ireland
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Vitamin D status
Tidsramme: One day measurement
|
25(OH)D status measured by Liquid Chromatography / Mass Spec (LC/MS)
|
One day measurement
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Bone turnover markers
Tidsramme: One day measurement
|
Osteocalcin, bone-specific alkaline phosphatase
|
One day measurement
|
|
Grip strength
Tidsramme: One day measurement
|
Measurement taken using hand grip dynamometer
|
One day measurement
|
|
Bone density
Tidsramme: One day measurement
|
Measured via Achilles heel ultrasound scanner, reported as T-score
|
One day measurement
|
|
Bone Health and lifestyle questionnaire
Tidsramme: One day measurement
|
General background information related to bone health
|
One day measurement
|
|
Functionality
Tidsramme: One day measurement
|
Timed up and go test
|
One day measurement
|
Samarbejdspartnere og efterforskere
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Sponsor
Samarbejdspartnere
Datoer for undersøgelser
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Studer store datoer
Studiestart (Faktiske)
28. maj 2019
Primær færdiggørelse (Forventet)
30. september 2021
Studieafslutning (Forventet)
30. september 2021
Datoer for studieregistrering
Først indsendt
11. maj 2020
Først indsendt, der opfyldte QC-kriterier
21. maj 2020
Først opslået (Faktiske)
22. maj 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. maj 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. maj 2020
Sidst verificeret
1. maj 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 18/NI/0114
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