Vitamin D StatusNCT04399291
Vitamin D Status and Bone Health of Older Adults in Care Facilities
An observational study of Vitamin D Status and Osteoporosis, run by University of Ulster at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Status, Osteoporosis, Sarcopenia
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 May 2019to 30 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
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.
Who may be able to join
- Currently residing (≥1 month) within a residential care facility in the Western Health and Social Care Trust in Northern Ireland
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Western Health and Social Care Trust care Home facilities
Londonderry, Co.Londonderry
About this study
Official title: 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.
- Conditions
- Vitamin D Status, Osteoporosis, Sarcopenia
- Keywords
- Vitamin D, Deficiency, Bone Health, Generic Health Relevance, Musculoskeletal Health, Observation
- Medical subject headings
- Osteoporosis, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Residential care facility residents | Older adults recruited from care homes in Northern Ireland |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D status
25(OH)D status measured by Liquid Chromatography / Mass Spec (LC/MS)
Measured: One day measurement
Secondary outcomes (5)
Bone turnover markers
Osteocalcin, bone-specific alkaline phosphatase
Measured: One day measurement
Grip strength
Measurement taken using hand grip dynamometer
Measured: One day measurement
Bone density
Measured via Achilles heel ultrasound scanner, reported as T-score
Measured: One day measurement
Bone Health and lifestyle questionnaire
General background information related to bone health
Measured: One day measurement
Functionality
Timed up and go test
Measured: One day measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start28 May 2019
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Why it stopped: COVID-19, study status being reviewed on an ongoing basis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- Western Health and Social Care Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04399291
- Sponsor's protocol ID
- 18/NI/0114
- Status last verified
- May 2020
- First submitted
- 11 May 2020
- Last updated
- 22 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Analysis of Vitamin D Status and Bone Health of Older Adults Within Residential Care Facilities in Northern Ireland.
- ClinicalTrials.gov ID
- NCT04399291
- Acronym / sponsor ID
- 18/NI/0114
- Conditions
- Vitamin D Status, Osteoporosis, Sarcopenia
- Keywords
- Vitamin D, Deficiency, Bone Health, Generic Health Relevance, Musculoskeletal Health, Observation
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: COVID-19, study status being reviewed on an ongoing basis.
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- Western Health and Social Care Trust
- Study start
- 28 May 2019 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 22 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Residential care facility residents | – | –Older adults recruited from care homes in Northern Ireland |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (1 listed)
- Currently residing (≥1 month) within a residential care facility in the Western Health and Social Care Trust in Northern Ireland
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vitamin D status
Time frame: One day measurement
25(OH)D status measured by Liquid Chromatography / Mass Spec (LC/MS)
5 secondary outcomes
Bone turnover markers
Time frame: One day measurement
Grip strength
Time frame: One day measurement
Bone density
Time frame: One day measurement
Bone Health and lifestyle questionnaire
Time frame: One day measurement
Functionality
Time frame: One day measurement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2020.
- Individual participant dataSharing planned: No
Related trials for Vitamin D Status
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Enrolling by invitationObservational study
Vitamin D Status and Its Influencing Factors in Zhejiang Province: A Multicenter Cross-Sectional Study
Vitamin D Deficiency
Recruiting
Impact of Trout Fish, Cow Milk With Egg, Vitamin D Supplementation, and Dietary Education on Vitamin D Status, Undernutrition, and Neurocognitive Outcomes Among School Children in Pakistan: An Open-label Individually Randomized Controlled Trial
Vitamin D 25-Hydroxylase Deficiency, Undernutrition
Recruiting
Supplementation of Cholecalciferol and Related Active Metabolites Through Bioenhancing Layer's Eggs
Healthy Adult Participants, Vitamin D Insufficiency
RecruitingObservational study
Vitamin D Status and Clinical Outcomes in Locally Advanced Cervical Cancer
Locally Advanced Cervical Cancer, Vitamin D Concentration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Status and Osteoporosis, run by University of Ulster at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 22 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin D status (time frame: One day measurement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2020.