FrailtyNCT04956705
Vitamin D and Calcium Supplementation at Danish Nursing Homes
A study testing Vitamin D and calcium in people with Frailty and Physical Disability, run by University College Copenhagen at 2 sites in Denmark.
Trial summary
Nursing home residents are in high risk of vitamin D deficiency, which negatively affects bone health. Vitamin D and calcium supplements have shown to increase bone density and reduce fracture risk and may affect daily physical functioning. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Frailty, Physical Disability, Aging
- What is being tested?
- Vitamin D and calcium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 2 sitesDenmark
- Study dates
- 20 Sep 2021to 1 Apr 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Being a resident at the participating nursing homes
- Understand and speak Danish in order to understand the study procedures
- Be able to give informed consent
Who cannot join
- Having kidney diseases
- Receiving medication which may induce adverse effects in combination with vitamin D and/or calcium supplements
- Being terminally ill
- Declared incompetent
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Frederiksgadecenteret
Haslev, 4690
Plejecentret Solbakken
Ringsted, 4100
About this study
Official title: Vitamin D and Calcium Supplementation at Danish Nursing Homes - Effects on Vitamin D Status and Physical Functioning
Nursing home residents are in high risk of vitamin D deficiency, which negatively affects bone health. Vitamin D and calcium supplements have shown to increase bone density and reduce fracture risk and may affect daily physical functioning. Therefore, The Danish Health Authority recommends all nursing home residents a daily supplement of 20 µg vitamin D and 800-1000 mg calcium. However, adherence to the recommendation is low.
The present project hypothesizes that this low adherence results in a high number of residents with a deficient or insufficient vitamin D status, and that daily physical functioning can be improved or maintained by an improved adherence to the recommendation.
Read the detailed description
Background: Residents in nursing homes belong to one of the high-risk groups when it comes to vitamin D deficiency, which is associated with increased risk of osteoporosis, muscle weakness and generally decreased physical functioning and frailty. Therefore, the Danish Health Authority recommends that all residents in nursing homes receive a daily supplement of 20 µg of vitamin D in addition to 800-1000 mg of calcium. Some systematic reviews and meta-analyses find that daily supplementation of 20 µg of vitamin D can improve physical functioning and muscle strength among older adults, whereas others do not find an effect. However, most studies are performed in non-institutionalized older adults.
An online survey conducted in May 2020 has revealed that the recommendation of giving residents in nursing homes a daily supplement of 20 µg vitamin D and 800-1000 mg calcium is not routine clinical practice in Denmark. The Danish Health Authority highlights The Model for Improvement as a tool to use when working with evidence-based practice within prevention and health promotion in the municipalities.
Objectives:
- To increase use of the recommended supplements with vitamin D and calcium among residents at nursing homes using The Model for Improvement as a methodological tool.
- To investigate the effect of improved vitamin D and calcium supplement use on vitamin D status and daily physical functioning among residents at nursing homes.
Hypotheses:
- Vitamin D status among residents at nursing homes are low and the majority can be defined as vitamin D insufficient.
- Vitamin D status and daily physical functioning of the residents are positively affected by an improved implementation of the recommendation.
Design and Methods: The project has a quasi-experimental design without control groups. It estimates the causal impact of The Model for Improvement on implementing the specific recommendation in a realistic setting at the nursing homes.
The study includes the following endpoints related to the older adults at the nursing homes evaluated before and after the intervention:
- Number of residents at the participating nursing homes taking supplementation of ≥20 µg of vitamin D and/or ≥800 mg of calcium ≥5 days/week.
- Number of residents at the participating nursing homes classified as having an insufficient and deficient vitamin D status (serum 25-hydroxyvitamin D (25(OH)D <50 nmol/L and <25 nmol/L, respectively)
- Mean daily physical functioning measured as muscle strength, 30-s chair-stand test, and a timed-up-and-go test.
- Conditions
- Frailty, Physical Disability, Aging, Muscle Weakness
- Being tested
- Vitamin D and calcium
- Medical subject headings
- Frailty, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D and calciumDietary supplement
Either as tablets, droplets or sprays. Preferably daily doses of 20 µg of vitamin D and 800-1000 mg of calcium as recommended.
| Study group | Role | What they receive |
|---|---|---|
| The Model for Improvement | Experimental | Together with the health care staff at the nursing homes, the project group will identify which strategies to implement in order to increase the number of residents receiving the recommended daily supplements of 20 µg of vitamin D and 800-1000 mg of calcium. The Model for Improvement will be the methodological framework for defining, implementing, and evaluating strategies. Receives: Dietary Supplement: Vitamin D and calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of residents having vitamin D and calcium supplements daily
Assessed as those having ≥ 20 µg vitamin D and/or ≥ 800 mg calcium ≥ 5 days /week
Measured: 6 months
Secondary outcomes (3)
Vitamin D status
Assessed as 25-hydroxyvitamin D
Measured: 6 months
Handgrip strength
Assessed with a digital handgrip dynamometer
Measured: 6 months
Physical functioning
Assessed with timed-up-and-go test and 30-s chair-stand test
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start20 Sep 2021
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The project estimates the impact of The Model for Improvement on implementing the recommendation of vitamin D and calcium supplementation at nursing homes. Furthermore, the project evaluates which effect an improved implementation can have on vitamin D status and physical functioning in nursing home residents.
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Charlotte Mortensen, University College Copenhagen
- Investigators
- Charlotte Mortensen, PhD, Principal investigator, University College Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956705
- Sponsor's protocol ID
- Alias: 200462
- Status last verified
- May 2022
- First submitted
- 30 Jun 2021
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mortensen C, Beck AM, Tetens I, Jeppesen C, Jorgensen SF, Nielsen LK, Kristensen M. Vitamin D Status and Physical Functioning in Nursing Home Residents after Improved Adherence to the Vitamin D and Calcium Recommendation-A Quasiexperimental Study. J Nutr Metab. 2024 Oct 5;2024:2405429. doi: 10.1155/2024/2405429. eCollection 2024.
PubMed 39398329
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D and Calcium Supplementation at Danish Nursing Homes - Effects on Vitamin D Status and Physical Functioning
- ClinicalTrials.gov ID
- NCT04956705
- Acronym / sponsor ID
- Alias: 200462
- Conditions
- Frailty, Physical Disability, Aging, Muscle Weakness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- University College CopenhagenUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 9 Jul 2021 (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.
Nursing home residents are in high risk of vitamin D deficiency, which negatively affects bone health. Vitamin D and calcium supplements have shown to increase bone density and reduce fracture risk and may affect daily physical functioning. Therefore, The Danish Health Authority recommends all nursing home residents a daily supplement of 20 µg vitamin D and 800-1000 mg calcium. However, adherence to the recommendation is low.
The present project hypothesizes that this low adherence results in a high number of residents with a deficient or insufficient vitamin D status, and that daily physical functioning can be improved or maintained by an improved adherence to the recommendation.
Detailed description
Background: Residents in nursing homes belong to one of the high-risk groups when it comes to vitamin D deficiency, which is associated with increased risk of osteoporosis, muscle weakness and generally decreased physical functioning and frailty. Therefore, the Danish Health Authority recommends that all residents in nursing homes receive a daily supplement of 20 µg of vitamin D in addition to 800-1000 mg of calcium. Some systematic reviews and meta-analyses find that daily supplementation of 20 µg of vitamin D can improve physical functioning and muscle strength among older adults, whereas others do not find an effect. However, most studies are performed in non-institutionalized older adults.
An online survey conducted in May 2020 has revealed that the recommendation of giving residents in nursing homes a daily supplement of 20 µg vitamin D and 800-1000 mg calcium is not routine clinical practice in Denmark. The Danish Health Authority highlights The Model for Improvement as a tool to use when working with evidence-based practice within prevention and health promotion in the municipalities.
Objectives:
- To increase use of the recommended supplements with vitamin D and calcium among residents at nursing homes using The Model for Improvement as a methodological tool.
- To investigate the effect of improved vitamin D and calcium supplement use on vitamin D status and daily physical functioning among residents at nursing homes.
Hypotheses:
- Vitamin D status among residents at nursing homes are low and the majority can be defined as vitamin D insufficient.
- Vitamin D status and daily physical functioning of the residents are positively affected by an improved implementation of the recommendation.
Design and Methods: The project has a quasi-experimental design without control groups. It estimates the causal impact of The Model for Improvement on implementing the specific recommendation in a realistic setting at the nursing homes.
The study includes the following endpoints related to the older adults at the nursing homes evaluated before and after the intervention:
- Number of residents at the participating nursing homes taking supplementation of ≥20 µg of vitamin D and/or ≥800 mg of calcium ≥5 days/week.
- Number of residents at the participating nursing homes classified as having an insufficient and deficient vitamin D status (serum 25-hydroxyvitamin D (25(OH)D <50 nmol/L and <25 nmol/L, respectively)
- Mean daily physical functioning measured as muscle strength, 30-s chair-stand test, and a timed-up-and-go test.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The project estimates the impact of The Model for Improvement on implementing the recommendation of vitamin D and calcium supplementation at nursing homes. Furthermore, the project evaluates which effect an improved implementation can have on vitamin D status and physical functioning in nursing home residents.
| Arm | Type | Receives |
|---|---|---|
| The Model for Improvement | Experimental | Dietary Supplement: Vitamin D and calciumTogether with the health care staff at the nursing homes, the project group will identify which strategies to implement in order to increase the number of residents receiving the recommended daily supplements of 20 µg of vitamin D and 800-1000 mg of calcium. The Model for Improvement will be the methodological framework for defining, implementing, and evaluating strategies. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Being a resident at the participating nursing homes
- Understand and speak Danish in order to understand the study procedures
- Be able to give informed consent
Key exclusion criteria (4 listed)
- Having kidney diseases
- Receiving medication which may induce adverse effects in combination with vitamin D and/or calcium supplements
- Being terminally ill
- Declared incompetent
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 |
|---|---|---|
| Vitamin D and calciumEither as tablets, droplets or sprays. Preferably daily doses of 20 µg of vitamin D and 800-1000 mg of calcium as recommended. | Dietary supplement | The Model for Improvement |
Primary outcome
Number of residents having vitamin D and calcium supplements daily
Time frame: 6 months
Assessed as those having ≥ 20 µg vitamin D and/or ≥ 800 mg calcium ≥ 5 days /week
3 secondary outcomes
Vitamin D status
Time frame: 6 months
Handgrip strength
Time frame: 6 months
Physical functioning
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Derived from this study: PubMed 39398329Mortensen C, Beck AM, Tetens I, Jeppesen C, Jorgensen SF, Nielsen LK, Kristensen M. Vitamin D Status and Physical Functioning in Nursing Home Residents after Improved Adherence to the Vitamin D and Calcium Recommendation-A Quasiexperimental Study. J Nutr Metab. 2024 Oct 5;2024:2405429. doi: 10.1155/2024/2405429. eCollection 2024.
- 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.
Charlotte Mortensen, PhD principal investigator
University College Copenhagen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D and calcium in people with Frailty and Physical Disability, run by University College Copenhagen at 2 sites in Denmark.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of residents having vitamin D and calcium supplements daily (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04956705, which also lists 1 linked publication.
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 18 May 2022.