Swiss Study on Vitamin D and Calcium in Nursing Homes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01653353
First received: July 23, 2012
Last updated: October 1, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Aging
Vitamin Deficiency
Behavioral: peer physician-applied recommendation to the physicians

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Swiss Study on Vitamin D and Calcium in Nursing Homes

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Proportion of compliance with federal recommendations [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
    We measure 25-hydroxyvitamin D serum levels among the residents.

  • Effect of nursing home-applied recommendations to physicians [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 71
Study Start Date: July 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Refusion of participation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01653353

Locations
Switzerland
Pflegeheim Sonnhalden
Arbon, TG, Switzerland, 9320
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01653353     History of Changes
Other Study ID Numbers: SSVDNH
Study First Received: July 23, 2012
Last Updated: October 1, 2013
Health Authority: Switzerland: Federal Office of Public Health

Keywords provided by University of Zurich:
nursing home
vitamin D supplements
calcium supplements
guideline adherence

Additional relevant MeSH terms:
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 30, 2014