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Vitamin D Status and Bone Health of Older Adults in Care Facilities

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04399291
Recruitment Status : Suspended (COVID-19, study status being reviewed on an ongoing basis.)
First Posted : May 22, 2020
Last Update Posted : May 22, 2020
Western Health and Social Care Trust
Information provided by (Responsible Party):
University of Ulster

Brief Summary:
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.

Condition or disease
Vitamin D Status Osteoporosis Sarcopenia

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Cross-sectional Analysis of Vitamin D Status and Bone Health of Older Adults Within Residential Care Facilities in Northern Ireland.
Actual Study Start Date : May 28, 2019
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Residential care facility residents
Older adults recruited from care homes in Northern Ireland

Primary Outcome Measures :
  1. Vitamin D status [ Time Frame: One day measurement ]
    25(OH)D status measured by Liquid Chromatography / Mass Spec (LC/MS)

Secondary Outcome Measures :
  1. Bone turnover markers [ Time Frame: One day measurement ]
    Osteocalcin, bone-specific alkaline phosphatase

  2. Grip strength [ Time Frame: One day measurement ]
    Measurement taken using hand grip dynamometer

  3. Bone density [ Time Frame: One day measurement ]
    Measured via Achilles heel ultrasound scanner, reported as T-score

  4. Bone Health and lifestyle questionnaire [ Time Frame: One day measurement ]
    General background information related to bone health

  5. Functionality [ Time Frame: One day measurement ]
    Timed up and go test

Biospecimen Retention:   Samples With DNA
White blood, serum, plasma, washed red cells, red cells, buffy coat

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04399291

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United Kingdom
Western Health and Social Care Trust care Home facilities
Londonderry, Co.Londonderry, United Kingdom
Sponsors and Collaborators
University of Ulster
Western Health and Social Care Trust
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Responsible Party: University of Ulster Identifier: NCT04399291    
Other Study ID Numbers: 18/NI/0114
First Posted: May 22, 2020    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Ulster:
Vitamin D
Bone Health
Generic Health Relevance
Musculoskeletal Health
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathological Conditions, Anatomical
Signs and Symptoms