Swiss Study on Vitamin D and Calcium in Nursing Homes

Aging Clinical Trial

Official title:

Swiss Study on Vitamin D and Calcium in Nursing Homes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01653353
• Other study ID #: SSVDNH
• Status: Completed
• Phase: N/A
• First received: July 23, 2012
• Last updated: October 1, 2013
• Start date: July 2012
• Est. completion date: September 2013

Study information

• Verified date: October 2013
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Federal Office of Public Health
• Study type: Interventional

Clinical Trial Summary

Residents of nursing homes are endangered by malnutrition and vitamin D deficiency. Our study checks compliance with Swiss federal recommendations on vitamin D and calcium supplementation among residents of a Swiss nursing home. A peer physician-applied recommendation on compliance with the federal recommendations with individual evaluation of the residents will be sent to the physicians in care. After one year, data will be collected again.

Description:

The investigators plan to get a complete sample of all inhabitants, so the only inclusion criterion is to get an informed consent either from the residents or from their relatives. The following data will be recorded: Year of birth, gender, height, weight, blood pressure and heart rate, daily calcium intake from diet, nursing home scales on pain, depression, dementia and activities of daily life, date of entry to the home, diagnosis and medication lists. From a venous blood sample the investigators get: calcium, phosphate, albumin, creatinin, 25-hydroxyvitamin D, parathormone (intact).

Primary endpoint: Proportion of medication lists of residents complying with federal recommendation on vitamin D and calcium supplementation.

Secondary endpoints: 25-hydroxyvitamin D levels, effect of an intervention with a nursing home-applied recommendation to the physicians.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Resident of nursing home on qualifying date

• Written informed consent by residents or their relatives

Exclusion Criteria:

• Refusion of participation

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Aging
• Avitaminosis
• Vitamin Deficiency

Intervention

Behavioral:
• peer physician-applied recommendation to the physicians
The peer physician-applied recommendation will include scientific information, practical recommendations to correctly supplement with calcium and vitamin D and a list of individual appraisals of the prescribed supplements among the residents.

Locations

Country	Name	City	State
Switzerland	Pflegeheim Sonnhalden	Arbon	TG

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of compliance with federal recommendations	We register the proportion of residents those calcium and vitamin D supplementation complies with Swiss federal recommendation.	up to 12 months	No
Secondary	25-hydroxyvitamin D serum levels	We measure 25-hydroxyvitamin D serum levels among the residents.	up to 12 months	No
Secondary	Effect of nursing home-applied recommendations to physicians	We check the effect of a nursing-home-applied recommendation to the physicians in care of the residents concerning correct supplementation with vitamin D and calcium on a) proportion of compliance with federal recommendations, b) 25-hydroxyvitamin D serum levels and c) medication costs.	up to 12 months	No