Swiss Study on Vitamin D and Calcium in Nursing Homes

October 1, 2013 updated by: University of Zurich
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • TG
      • Arbon, TG, Switzerland, 9320
        • Pflegeheim Sonnhalden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Resident of nursing home on qualifying date
  • Written informed consent by residents or their relatives

Exclusion Criteria:

  • Refusion of participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Entire group
A peer-applied guideline will be applied to the physicians.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of compliance with federal recommendations
Time Frame: up to 12 months
We register the proportion of residents those calcium and vitamin D supplementation complies with Swiss federal recommendation.
up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
25-hydroxyvitamin D serum levels
Time Frame: up to 12 months
We measure 25-hydroxyvitamin D serum levels among the residents.
up to 12 months
Effect of nursing home-applied recommendations to physicians
Time Frame: up to 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Markus P. Gnädinger, MD, Zurich University
  • Study Director: Heike A. Bischoff-Ferrari, MD, DrPH, Prof, Zurich University
  • Study Chair: Andreas Egli, MD, Zurich University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

July 23, 2012

First Submitted That Met QC Criteria

July 26, 2012

First Posted (Estimate)

July 31, 2012

Study Record Updates

Last Update Posted (Estimate)

October 7, 2013

Last Update Submitted That Met QC Criteria

October 1, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSVDNH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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