Vitamin D DeficiencyNCT04395638
Replenishing and Maintaining Vitamin D Status in Older Adults in Residential Care Facilities in NI
A study testing 3200IU Vitamin D3 per day for 8 weeks and 20,000IU Vitamin D3 per week for 8 weeks in people with Vitamin D Deficiency, run by University of Ulster at 1 site in United Kingdom.
Trial summary
The vitamin D status of older adults in residential care facilities in Northern Ireland (NI) is currently unknown. An observation study is currently being carried out by Ulster University and the Western Health \& Social Care Trust (WHSCT) to provide data on the prevalence of vitamin-D deficiency among older adults… 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 Deficiency
- What is being tested?
- 3200IU Vitamin D3 per day for 8 weeks and 20,000IU Vitamin D3 per week for 8 weeks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2020to 28 Feb 2021
- Phase
- Interventional
- 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
Who may be able to join
- Currently residing (≥1 month) within residential care facilities in Northern Ireland and who have previously undertaken the observation study (full title: A cross-sectional analysis of vitamin D status and bone health of older adults within residential care facilities in Northern Ireland) and have been identified as vitamin D deficient.
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: Replenishing and Maintaining Vitamin D Status in Deficient Older Adults in Residential Care Facilities in Northern Ireland
The vitamin D status of older adults in residential care facilities in Northern Ireland (NI) is currently unknown. An observation study is currently being carried out by Ulster University and the Western Health \& Social Care Trust (WHSCT) to provide data on the prevalence of vitamin-D deficiency among older adults within residential care facilities in NI. It is expected that some 40% of the cohort will be deficient in vitamin D and will require immediate replenishment of vitamin D status. Therefore, as a follow up to the observational study, an intervention study will be conducted, where participants identified as vitamin D deficient (25(OH)D) status <30nmol/L (cut-off currently used by the WHSCT will be re-contacted and provided with a vitamin D supplement. The aim of this study is to investigate the dose and duration of vitamin D supplementation that is required to replenish and maintain vitamin D status in older adults with vitamin D deficiency within residential care facilities. Participants will be randomly assigned to receive one of two supplementation regimes: 3200IU/day vitamin D3 or 20,000IU/week vitamin D3. Blood samples (no more than 20ml per appointment) will be taken at 4 different time points: week 0, week 2, week 4 and week 8. These two doses are routinely used in clinical practice for remedial supplementation of vitamin D and have been chosen based upon their availability from manufacturers of vitamin D supplements. Also, albeit these doses are currently routinely used to replenish vitamin D status little is known on how effective they are and how soon vitamin D status is optimised. Clinicians can only administer medication for the management of osteoporosis (e.g. bisphosphonates) once vitamin D status is optimised. Therefore, measurements will be taken every two weeks to establish response to the remedial supplementation. This project provides a unique opportunity to monitor the replenishment and maintenance of vitamin D status following remedial supplementation more regularly (at weeks 0,2,4,8) than would be done under standard National Health Service care. This does and duration of vitamin D required to replenish vitamin D deficiency in older adults is currently ambiguous within the literature and clinical care.
- Conditions
- Vitamin D Deficiency
- Being tested
- 3200IU Vitamin D3 per day for 8 weeks, 20,000IU Vitamin D3 per week for 8 weeks
- Keywords
- Vitamin D, Deficiency, Bone Health, Generic Health Relevance, Musculoskeletal Health, Intervention
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3200IU Vitamin D3 per day for 8 weeksDietary supplement
3200IU Vitamin D3 per day for 8 weeks
20,000IU Vitamin D3 per week for 8 weeksDietary supplement
20,000IU Vitamin D3 per week for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Weekly Vitamin D group | Experimental | Not described Receives: Dietary Supplement: 20,000IU Vitamin D3 per week for 8 weeks |
| Daily Vitamin D group | Experimental | Not described Receives: Dietary Supplement: 3200IU Vitamin D3 per day for 8 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D status
Plasma 25(OH)D status analysis by Liquid Chromatography / Mass Spec (LC/MS)
Measured: Change between baseline (week 0 pre-intervention) and weeks 2, 4, 8 post-intervention
Secondary outcomes (2)
Osteocalcin concentration
Bone turnover marker
Measured: Change between baseline (week 0 pre-intervention) and weeks 2, 4, 8 post-intervention
Bone-specific alkaline phosphatase concentration
Bone turnover marker
Measured: Change between baseline (week 0 pre-intervention) and weeks 2, 4, 8 post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start1 Sep 2020 (estimated)
- Primary completion28 Feb 2021 (estimated)
- Study completion28 Feb 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 DeficiencyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT04395638
- Sponsor's protocol ID
- 20/NI/0031
- Status last verified
- May 2020
- First submitted
- 11 May 2020
- Last updated
- 21 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 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Replenishing and Maintaining Vitamin D Status in Deficient Older Adults in Residential Care Facilities in Northern Ireland
- ClinicalTrials.gov ID
- NCT04395638
- Acronym / sponsor ID
- 20/NI/0031
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D, Deficiency, Bone Health, Generic Health Relevance, Musculoskeletal Health, Intervention
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: COVID-19 study status being reviewed on an ongoing basis.
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- Western Health and Social Care Trust
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 28 Feb 2021 (estimated)
- Study completion
- 28 Feb 2021 (estimated)
- First posted
- 20 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.
The vitamin D status of older adults in residential care facilities in Northern Ireland (NI) is currently unknown. An observation study is currently being carried out by Ulster University and the Western Health \& Social Care Trust (WHSCT) to provide data on the prevalence of vitamin-D deficiency among older adults within residential care facilities in NI. It is expected that some 40% of the cohort will be deficient in vitamin D and will require immediate replenishment of vitamin D status. Therefore, as a follow up to the observational study, an intervention study will be conducted, where participants identified as vitamin D deficient (25(OH)D) status <30nmol/L (cut-off currently used by the WHSCT will be re-contacted and provided with a vitamin D supplement. The aim of this study is to investigate the dose and duration of vitamin D supplementation that is required to replenish and maintain vitamin D status in older adults with vitamin D deficiency within residential care facilities. Participants will be randomly assigned to receive one of two supplementation regimes: 3200IU/day vitamin D3 or 20,000IU/week vitamin D3. Blood samples (no more than 20ml per appointment) will be taken at 4 different time points: week 0, week 2, week 4 and week 8. These two doses are routinely used in clinical practice for remedial supplementation of vitamin D and have been chosen based upon their availability from manufacturers of vitamin D supplements. Also, albeit these doses are currently routinely used to replenish vitamin D status little is known on how effective they are and how soon vitamin D status is optimised. Clinicians can only administer medication for the management of osteoporosis (e.g. bisphosphonates) once vitamin D status is optimised. Therefore, measurements will be taken every two weeks to establish response to the remedial supplementation. This project provides a unique opportunity to monitor the replenishment and maintenance of vitamin D status following remedial supplementation more regularly (at weeks 0,2,4,8) than would be done under standard National Health Service care. This does and duration of vitamin D required to replenish vitamin D deficiency in older adults is currently ambiguous within the literature and clinical care.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weekly Vitamin D group | Experimental | Dietary Supplement: 20,000IU Vitamin D3 per week for 8 weeks |
| Daily Vitamin D group | Experimental | Dietary Supplement: 3200IU Vitamin D3 per day for 8 weeks |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Currently residing (≥1 month) within residential care facilities in Northern Ireland and who have previously undertaken the observation study (full title: A cross-sectional analysis of vitamin D status and bone health of older adults within residential care facilities in Northern Ireland) and have been identified as vitamin D deficient.
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3200IU Vitamin D3 per day for 8 weeks3200IU Vitamin D3 per day for 8 weeks | Dietary supplement | Daily Vitamin D group |
| 20,000IU Vitamin D3 per week for 8 weeks20,000IU Vitamin D3 per week for 8 weeks | Dietary supplement | Weekly Vitamin D group |
Primary outcome
Vitamin D status
Time frame: Change between baseline (week 0 pre-intervention) and weeks 2, 4, 8 post-intervention
Plasma 25(OH)D status analysis by Liquid Chromatography / Mass Spec (LC/MS)
2 secondary outcomes
Osteocalcin concentration
Time frame: Change between baseline (week 0 pre-intervention) and weeks 2, 4, 8 post-intervention
Bone-specific alkaline phosphatase concentration
Time frame: Change between baseline (week 0 pre-intervention) and weeks 2, 4, 8 post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- Individual participant dataSharing planned: No
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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?
A study testing 3200IU Vitamin D3 per day for 8 weeks and 20,000IU Vitamin D3 per week for 8 weeks in people with Vitamin D Deficiency, 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 21 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: Change between baseline (week 0 pre-intervention) and weeks 2, 4, 8 post-intervention). 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 21 May 2020.