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
|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|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|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|
|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).
- 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).
- 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.
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
|Kingsway Arms- Aurora Retirement Centre|
|Aurora, Ontario, Canada, L4G 2C7|
|Principal Investigator:||Reinhold Vieth, PhD,FCACB||U of Toronto, Mount Sinai Hospital|
|Principal Investigator:||Pierre Geoffroy, MD||Aurora Retirement Centre|