Vitamin D and Calcium Supplementation at Danish Nursing Homes
Primary Purpose
Frailty, Physical Disability, Aging
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Vitamin D and calcium
Sponsored by
About this trial
This is an interventional health services research trial for Frailty
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Having kidney diseases
- Receiving medication which may induce adverse effects in combination with vitamin D and/or calcium supplements
- Being terminally ill
- Declared incompetent
Sites / Locations
- Frederiksgadecenteret
- Plejecentret Solbakken
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
The Model for Improvement
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Vitamin D status
Assessed as 25-hydroxyvitamin D
Handgrip strength
Assessed with a digital handgrip dynamometer
Physical functioning
Assessed with timed-up-and-go test and 30-s chair-stand test
Full Information
NCT ID
NCT04956705
First Posted
June 30, 2021
Last Updated
May 17, 2022
Sponsor
University College Copenhagen
Collaborators
University of Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT04956705
Brief Title
Vitamin D and Calcium Supplementation at Danish Nursing Homes
Official Title
Vitamin D and Calcium Supplementation at Danish Nursing Homes - Effects on Vitamin D Status and Physical Functioning
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 20, 2021 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College Copenhagen
Collaborators
University of Copenhagen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty, Physical Disability, Aging, Muscle Weakness
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
109 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The Model for Improvement
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D and calcium
Intervention Description
Either as tablets, droplets or sprays. Preferably daily doses of 20 µg of vitamin D and 800-1000 mg of calcium as recommended.
Primary Outcome Measure Information:
Title
Number of residents having vitamin D and calcium supplements daily
Description
Assessed as those having ≥ 20 µg vitamin D and/or ≥ 800 mg calcium ≥ 5 days /week
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Vitamin D status
Description
Assessed as 25-hydroxyvitamin D
Time Frame
6 months
Title
Handgrip strength
Description
Assessed with a digital handgrip dynamometer
Time Frame
6 months
Title
Physical functioning
Description
Assessed with timed-up-and-go test and 30-s chair-stand test
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Having kidney diseases
Receiving medication which may induce adverse effects in combination with vitamin D and/or calcium supplements
Being terminally ill
Declared incompetent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charlotte Mortensen, PhD
Organizational Affiliation
University College Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Frederiksgadecenteret
City
Haslev
ZIP/Postal Code
4690
Country
Denmark
Facility Name
Plejecentret Solbakken
City
Ringsted
ZIP/Postal Code
4100
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Vitamin D and Calcium Supplementation at Danish Nursing Homes
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