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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University of Toronto.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Reinhold Vieth, University of Toronto
ClinicalTrials.gov Identifier:
NCT01555424
First received: March 13, 2012
Last updated: March 14, 2012
Last verified: March 2012

March 13, 2012
March 14, 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 ] [ Designated as safety issue: No ]
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
Complete list of historical versions of study NCT01555424 on ClinicalTrials.gov Archive Site
A change in wellbeing scores using an SF-36 survey in the older institutionalized adults [ Time Frame: 2 months ] [ Designated as safety issue: No ]
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
28
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
Both
70 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01555424
M2327
No
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