ClinicalTrials.gov
ClinicalTrials.gov Menu

Vitamin D Fortified Cheese and Well-being in the Institutionalized Elderly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01555424
Recruitment Status : Unknown
Verified March 2012 by Reinhold Vieth, University of Toronto.
Recruitment status was:  Active, not recruiting
First Posted : March 15, 2012
Last Update Posted : March 15, 2012
Sponsor:
Information provided by (Responsible Party):
Reinhold Vieth, University of Toronto

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The investigators hypotheses is that the consumption of the investigators vitamin D fortified cheese will result in an increase in serum 25-hydroxy vitamin D levels in older institutionalized adults. Also, the consumption of the cheese with the higher amount of vitamin D will result in an improvement in wellbeing scores.

Condition or disease Intervention/treatment Phase
The Focus is to Assess 25-hydroxyvitamin D Levels and Well-being Dietary Supplement: High dose Dietary Supplement: Reference dose Not Applicable

Detailed Description:

The institute of medicine increased the dietary reference intakes of vitamin D for all of the age groups. The Recommended Daily Allowance (RDA) is now 800 IU for older adults over the age of 70, and the Tolerable Upper Level (UL) is 4000 IU daily. Canadians are known to have an inadequate vitamin D status, and older institutionalized adults are particularly susceptible to this. One strategy to correct this is to fortify more kinds of foods with vitamin D. We have already demonstrated that we can get vitamin D into cheddar cheese and it is as biologically available as vitamin D in the liquid supplement.

This new project aims to optimize the fortification process and deliver all of the vitamin D into cheddar cheese, and to measure its bioavailability and related changes in well-being during winter. We will assess the well being of the older institutionalized adults by administering the SF-36v2 health survey.


Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Bioavailability of Casein-bound Vitamin D From Fortified Cheese and Its Effects on the Well-being of the Institutionalized Elderly
Study Start Date : February 2012
Estimated Primary Completion Date : April 2012
Estimated Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: High dose Dietary Supplement: High dose
This arm of the study receives a higher dose of the vitamin D fortified cheese (28,000IU/ 50g of cheddar cheese eaten once a week).
Active Comparator: Reference dose Dietary Supplement: Reference dose
This arm of the study receives a lower dose of the vitamin D fortified cheese (200IU/ 50g of cheddar cheese eaten once a week).


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. The bioavailability of vitamin D from cheddar cheese fortified with vitamin D, in older institutionalized adults [ Time Frame: 2 months ]
    We are adminstering 2 doses of vitamin D fortified cheese. One cheese contains a higher 28,000 IU/week dose that we expect to see health benefits with. The other cheese contains a 200IU/week dose that is similar to the current milk fortification practice in Canada (100IU per serving).


Secondary Outcome Measures :
  1. A change in wellbeing scores using an SF-36 survey in the older institutionalized adults [ Time Frame: 2 months ]
    We have previously shown that a group of adults showed an improvement in their wellbeing scores after the consumption of 28,000 IU/week of vitamin D during the winter months. Therefore, we will assess whether well-being changes in older institutionalized adults after the consumption of the vitamin D fortifed cheese, by using an SF-36 well-being survey.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Lactose intolerance
  • Generally "Healthy", unless disease status deemed clinically significant and unable to participate by the attending physician.

Exclusion Criteria:

  • Hypercalcemia/hypercalciuria
  • Interfering medications
  • Significant sun exposure in the months before and during the study
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01555424


Locations
Canada, Ontario
Kingsway Arms- Aurora Retirement Centre
Aurora, Ontario, Canada, L4G 2C7
Sponsors and Collaborators
University of Toronto
Investigators
Principal Investigator: Reinhold Vieth, PhD,FCACB U of Toronto, Mount Sinai Hospital
Principal Investigator: Pierre Geoffroy, MD Aurora Retirement Centre
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Responsible Party: Reinhold Vieth, Dr., University of Toronto
ClinicalTrials.gov Identifier: NCT01555424     History of Changes
Other Study ID Numbers: M2327
First Posted: March 15, 2012    Key Record Dates
Last Update Posted: March 15, 2012
Last Verified: March 2012

Keywords provided by Reinhold Vieth, University of Toronto:
25-hydroxyvitamin D
Institutionalized seniors
SF-36 survey
Winter

Additional relevant MeSH terms:
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
 Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents