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Completed

NCT Number: NCT04956705

Vitamin D and Calcium Supplementation at Danish Nursing Homes

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Frederiksgadecenteret, Haslev, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D and calcium

Dietary Supplement

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Vitamin D status

    Time frame: 6 months

    Assessed as 25-hydroxyvitamin D

  2. Handgrip strength

    Time frame: 6 months

    Assessed with a digital handgrip dynamometer

  3. Physical functioning

    Time frame: 6 months

    Assessed with timed-up-and-go test and 30-s chair-stand test

Sponsors and collaborators

Lead sponsor

University College Copenhagen

Other

Collaborators

  • University of Copenhagen

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 9, 2021
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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