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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-04-30

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.

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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High dose

Group Type ACTIVE_COMPARATOR

High dose

Intervention Type DIETARY_SUPPLEMENT

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).

Reference dose

Group Type ACTIVE_COMPARATOR

Reference dose

Intervention Type DIETARY_SUPPLEMENT

This arm of the study receives a lower dose of the vitamin D fortified cheese (200IU/ 50g of cheddar cheese eaten once a week).

Interventions

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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).

Intervention Type 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).

Intervention Type DIETARY_SUPPLEMENT

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.