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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Bioavailability of Casein-bound Vitamin D From Fortified Cheese and Its Effects on the Well-being of the Institutionalized Elderly

Conditions
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The Focus is to Assess 25-hydroxyvitamin D Levels and Well-being

Intervention / Treatment
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* Dietary Supplement: High dose
* Dietary Supplement: Reference dose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High dose<br> | Dietary Supplement: High dose<br>* 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).<br>|
| Active Comparator: Reference dose<br> | Dietary Supplement: Reference dose<br>* This arm of the study receives a lower dose of the vitamin D fortified cheese (200IU/ 50g of cheddar cheese eaten once a week).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The bioavailability of vitamin D from cheddar cheese fortified with vitamin D, in older institutionalized adults | 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). | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A change in wellbeing scores using an SF-36 survey in the older institutionalized adults | 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. | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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25-hydroxyvitamin D, Institutionalized seniors, SF-36 survey, Winter