Vitamin D and Calcium Supplementation at Danish Nursing Homes

Aging Clinical Trial

Official title:

Vitamin D and Calcium Supplementation at Danish Nursing Homes - Effects on Vitamin D Status and Physical Functioning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04956705
• Other study ID #: Alias: 200462
• Status: Completed
• Phase: N/A
• Start date: September 20, 2021
• Est. completion date: April 1, 2022

Study information

• Verified date: May 2022
• Source: University College Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Frailty
• Muscle Weakness
• Physical Disability

Intervention

Dietary Supplement:
• Vitamin D and calcium
Either as tablets, droplets or sprays. Preferably daily doses of 20 µg of vitamin D and 800-1000 mg of calcium as recommended.

Locations

Country	Name	City	State
Denmark	Frederiksgadecenteret	Haslev
Denmark	Plejecentret Solbakken	Ringsted

Sponsors (2)

Lead Sponsor	Collaborator
University College Copenhagen	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months
Secondary	Vitamin D status	Assessed as 25-hydroxyvitamin D	6 months
Secondary	Handgrip strength	Assessed with a digital handgrip dynamometer	6 months
Secondary	Physical functioning	Assessed with timed-up-and-go test and 30-s chair-stand test	6 months