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Swiss Study on Vitamin D and Calcium in Nursing Homes

Primary Purpose

Aging, Vitamin Deficiency

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

peer physician-applied recommendation to the physicians

About this trial

This is an interventional prevention trial for Aging focused on measuring nursing home, vitamin D supplements, calcium supplements, guideline adherence

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Refusion of participation

Sites / Locations

Pflegeheim Sonnhalden

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Entire group

Arm Description

A peer-applied guideline will be applied to the physicians.

Outcomes

Primary Outcome Measures

Proportion of compliance with federal recommendations

We register the proportion of residents those calcium and vitamin D supplementation complies with Swiss federal recommendation.

Secondary Outcome Measures

25-hydroxyvitamin D serum levels

We measure 25-hydroxyvitamin D serum levels among the residents.

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.

Full Information

NCT ID

NCT01653353

First Posted

July 23, 2012

Last Updated

October 1, 2013

Sponsor

University of Zurich

1. Study Identification

Unique Protocol Identification Number

NCT01653353

Brief Title

Swiss Study on Vitamin D and Calcium in Nursing Homes

Official Title

Swiss Study on Vitamin D and Calcium in Nursing Homes

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Completed

Study Start Date

July 2012 (undefined)

Primary Completion Date

September 2013 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Zurich

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aging, Vitamin Deficiency

Keywords

nursing home, vitamin D supplements, calcium supplements, guideline adherence

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

71 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Entire group

Arm Type

Experimental

Arm Description

A peer-applied guideline will be applied to the physicians.

Intervention Type

Behavioral

Intervention Name(s)

peer physician-applied recommendation to the physicians

Intervention Description

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.

Primary Outcome Measure Information:

Title

Proportion of compliance with federal recommendations

Description

We register the proportion of residents those calcium and vitamin D supplementation complies with Swiss federal recommendation.

Time Frame

up to 12 months

Secondary Outcome Measure Information:

Title

25-hydroxyvitamin D serum levels

Description

We measure 25-hydroxyvitamin D serum levels among the residents.

Time Frame

up to 12 months

Title

Effect of nursing home-applied recommendations to physicians

Description

Time Frame

up to 12 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Resident of nursing home on qualifying date Written informed consent by residents or their relatives Exclusion Criteria: Refusion of participation

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Markus P. Gnädinger, MD

Organizational Affiliation

Zurich University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Heike A. Bischoff-Ferrari, MD, DrPH, Prof

Organizational Affiliation

Zurich University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Andreas Egli, MD

Organizational Affiliation

Zurich University

Official's Role

Study Chair

Facility Information:

Facility Name

Pflegeheim Sonnhalden

City

Arbon

State/Province

ZIP/Postal Code

9320

Country

Switzerland

12. IPD Sharing Statement

Learn more about this trial

Swiss Study on Vitamin D and Calcium in Nursing Homes

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