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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01653353
Other study ID # SSVDNH
Secondary ID
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


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
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