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

NCT04399291 | Suspended

• 1 other identifier: 18/NI/0114
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Status; Osteoporosis; Sarcopenia

Keywords

Vitamin D; Deficiency; Bone Health; Generic Health Relevance; Musculoskeletal Health; Observation

Outcome Measures

Primary Outcomes (1)

• Vitamin D status

  25(OH)D status measured by Liquid Chromatography / Mass Spec (LC/MS)

  One day measurement

Secondary Outcomes (5)

• Bone turnover markers

  One day measurement

• Grip strength

  One day measurement

• Bone density

  One day measurement

• Bone Health and lifestyle questionnaire

  One day measurement

• Functionality

  One day measurement

Study Arms (1)

Residential care facility residents

Older adults recruited from care homes in Northern Ireland

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• Currently residing (≥1 month) within a residential care facility in the Western Health and Social Care Trust in Northern Ireland

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Ulster: lead
• Western Health and Social Care Trust: collaborator

Study Sites (1)

Western Health and Social Care Trust care Home facilities

Londonderry, Co.Londonderry, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

White blood, serum, plasma, washed red cells, red cells, buffy coat

MeSH Terms

Conditions

Osteoporosis; Sarcopenia

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 22, 2020
• Study Start: May 28, 2019
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: May 22, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)