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

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

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.

Study Overview

• Status: Unknown
• Conditions: The Focus is to Assess 25-hydroxyvitamin D Levels and Well-being
• Intervention / Treatment: Dietary supplement: High dose; Dietary supplement: Reference dose

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: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Aurora, Ontario, Canada, L4G 2C7
      • Kingsway Arms- Aurora Retirement Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Toronto
• Investigators: Principal Investigator: Reinhold Vieth, PhD,FCACB, U of Toronto, Mount Sinai Hospital; Principal Investigator: Pierre Geoffroy, MD, Aurora Retirement Centre

Publications and helpful links

General Publications

• Wagner D, Sidhom G, Whiting SJ, Rousseau D, Vieth R. The bioavailability of vitamin D from fortified cheeses and supplements is equivalent in adults. J Nutr. 2008 Jul;138(7):1365-71. doi: 10.1093/jn/138.7.1365.
• Vieth R, Kimball S, Hu A, Walfish PG. Randomized comparison of the effects of the vitamin D3 adequate intake versus 100 mcg (4000 IU) per day on biochemical responses and the wellbeing of patients. Nutr J. 2004 Jul 19;3:8. doi: 10.1186/1475-2891-3-8.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Anticipated): April 1, 2012
• Study Completion (Anticipated): April 1, 2012

Study Registration Dates

• First Submitted: March 13, 2012
• First Submitted That Met QC Criteria: March 14, 2012
• First Posted (Estimate): March 15, 2012

Study Record Updates

• Last Update Posted (Estimate): March 15, 2012
• Last Update Submitted That Met QC Criteria: March 14, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: 25-hydroxyvitamin D; Institutionalized seniors; Winter; SF-36 survey
• Other Study ID Numbers: M2327