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. 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
Information provided by (Responsible Party):
Reinhold Vieth, University of Toronto

March 13, 2012
March 15, 2012
March 15, 2012
February 2012
April 2012   (Final data collection date for primary outcome measure)
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).
Same as current
No Changes Posted
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.
Same as current
Not Provided
Not Provided
Vitamin D Fortified Cheese and Well-being in the Institutionalized Elderly
Bioavailability of Casein-bound Vitamin D From Fortified Cheese and Its Effects on the Well-being of the Institutionalized Elderly
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.

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.

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
The Focus is to Assess 25-hydroxyvitamin D Levels and Well-being
  • 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).
  • 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).
  • Active Comparator: High dose
    Intervention: Dietary Supplement: High dose
  • Active Comparator: Reference dose
    Intervention: Dietary Supplement: Reference dose

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
April 2012
April 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
70 Years and older   (Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Reinhold Vieth, University of Toronto
University of Toronto
Not Provided
Principal Investigator: Reinhold Vieth, PhD,FCACB U of Toronto, Mount Sinai Hospital
Principal Investigator: Pierre Geoffroy, MD Aurora Retirement Centre
University of Toronto
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP