Vitamin D and Calcium Supplementation at Danish Nursing Homes

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.

Study Overview

• Status: Completed
• Conditions: Muscle Weakness; Frailty; Aging; Physical Disability
• Intervention / Treatment: Dietary supplement: Vitamin D and calcium

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 Type: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Haslev, Denmark, 4690
    • Frederiksgadecenteret
  • Ringsted, Denmark, 4100
    • Plejecentret Solbakken

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: The Model for Improvement; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vitamin D status	Assessed as 25-hydroxyvitamin D	6 months
Handgrip strength	Assessed with a digital handgrip dynamometer	6 months
Physical functioning	Assessed with timed-up-and-go test and 30-s chair-stand test	6 months

Collaborators and Investigators

• Sponsor: University College Copenhagen
• Collaborators: University of Copenhagen
• Investigators: Principal Investigator: Charlotte Mortensen, PhD, University College Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2021
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): April 1, 2022

Study Registration Dates

• First Submitted: June 30, 2021
• First Submitted That Met QC Criteria: June 30, 2021
• First Posted (Actual): July 9, 2021

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Weakness; Frailty; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Calcium
• Other Study ID Numbers: Alias: 200462

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No