NCT01653353

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 31, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

October 7, 2013

Status Verified

October 1, 2013

Enrollment Period

1.2 years

First QC Date

July 23, 2012

Last Update Submit

October 1, 2013

Conditions

AgingVitamin Deficiency

Keywords

nursing homevitamin D supplementscalcium supplementsguideline adherence

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • 25-hydroxyvitamin D serum levels

    up to 12 months

  • Effect of nursing home-applied recommendations to physicians

    up to 12 months

Study Arms (1)

Entire group

EXPERIMENTAL

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

Behavioral: peer physician-applied recommendation to the physicians

Interventions

peer physician-applied recommendation to the physiciansBEHAVIORAL

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.

Entire group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Refusion of participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pflegeheim Sonnhalden

Arbon, Thurgau, 9320, Switzerland

Location

MeSH Terms

Conditions

Avitaminosis

Condition Hierarchy (Ancestors)

Deficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Markus P. Gnädinger, MD

    University of Zurich

    PRINCIPAL INVESTIGATOR

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

    University of Zurich

    STUDY DIRECTOR

  • Andreas Egli, MD

    University of Zurich

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2012

First Posted

July 31, 2012

Study Start

July 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

October 7, 2013

Record last verified: 2013-10

Locations

CH(1)