Vitamin D and Calcium Supplementation at Danish Nursing Homes

NCT04956705 | Completed

• 1 other identifier: Alias: 200462
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 2

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.

Conditions

Frailty; Physical Disability; Aging; Muscle Weakness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Vitamin D status

  6 months

• Handgrip strength

  6 months

• Physical functioning

  6 months

Study Arms (1)

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.

Dietary Supplement: Vitamin D and calcium

Interventions

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.

The Model for Improvement

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Having kidney diseases
• Receiving medication which may induce adverse effects in combination with vitamin D and/or calcium supplements
• Being terminally ill
• Declared incompetent

Sponsors & Collaborators

• University College Copenhagen: lead
• University of Copenhagen: collaborator

Study Sites (2)

Frederiksgadecenteret

Haslev, 4690, Denmark

Location

Plejecentret Solbakken

Ringsted, 4100, Denmark

Location

Related Publications (1)

• 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.

  PMID: 39398329 DERIVED

MeSH Terms

Conditions

Frailty; Muscle Weakness

Interventions

Vitamin D; Calcium

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors

Study Officials

• Charlotte Mortensen, PhD

  University College Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 9, 2021
• Study Start: September 20, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)