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

Not Applicable

• Conditions: The Focus is to Assess 25-hydroxyvitamin D Levels and Well-being
• Interventions: Dietary Supplement: High dose; Dietary Supplement: Reference dose

• Registration Number: NCT01555424
• Lead Sponsor: University of Toronto

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 Timeline

• Study Start: 2012-02
• Status Verified: 2012-03
• Study First Submitted: 2012-03-13
• Study First Submitted QC: 2012-03-14
• Last Update Submitted: 2012-03-14
• Study First Posted: 2012-03-15
• Last Update Posted: 2012-03-15
• Primary Completion: 2012-04
• Study Completion: 2012-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Lactose intolerance
• Generally "Healthy", unless disease status deemed clinically significant and unable to participate by the attending physician.

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Exclusion Criteria

• Hypercalcemia/hypercalciuria
• Interfering medications
• Significant sun exposure in the months before and during the study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose	High dose	-
Reference dose	Reference dose	-

Primary Outcome Measures

Name	Time	Method
The bioavailability of vitamin D from cheddar cheese fortified with vitamin D, in older institutionalized adults	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).

Secondary Outcome Measures

Name	Time	Method
A change in wellbeing scores using an SF-36 survey in the older institutionalized adults	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.

Trial Locations

Locations (1)

Kingsway Arms- Aurora Retirement Centre; 🇨🇦 Aurora, Ontario, Canada