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

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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

Tracking Information
First Submitted Date  ICMJE March 13, 2012
First Posted Date  ICMJE March 15, 2012
Last Update Posted Date March 15, 2012
Study Start Date  ICMJE February 2012
Estimated Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2012)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2012)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin D Fortified Cheese and Well-being in the Institutionalized Elderly
Official Title  ICMJE Bioavailability of Casein-bound Vitamin D From Fortified Cheese and Its Effects on the Well-being of the Institutionalized Elderly
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Condition  ICMJE The Focus is to Assess 25-hydroxyvitamin D Levels and Well-being
Intervention  ICMJE
  • 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).
Study Arms  ICMJE
  • Active Comparator: High dose
    Intervention: Dietary Supplement: High dose
  • Active Comparator: Reference dose
    Intervention: Dietary Supplement: Reference dose
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: March 14, 2012)
28
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2012
Estimated Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01555424
Other Study ID Numbers  ICMJE M2327
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Reinhold Vieth, University of Toronto
Study Sponsor  ICMJE University of Toronto
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Reinhold Vieth, PhD,FCACB U of Toronto, Mount Sinai Hospital
Principal Investigator: Pierre Geoffroy, MD Aurora Retirement Centre
PRS Account University of Toronto
Verification Date March 2012

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