Clinical trial NCT01555424: Vitamin D Fortified Cheese and Well-being in the Institutionalized Elderly
Official title: Bioavailability of Casein-bound Vitamin D From Fortified Cheese and Its Effects on the Well-being of the Institutionalized Elderly
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: The Focus is to Assess 25-hydroxyvitamin D Levels and Well-being
Keywords: 25-hydroxyvitamin D
Institutionalized seniors
SF-36 survey
Winter
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2012-03-15
Enrollment: 28
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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

Primary outcomes:
measure: The bioavailability of vitamin D from cheddar cheese fortified with vitamin D, in older institutionalized adults
timeFrame: 2 months
Secondary outcomes:
measure: A change in wellbeing scores using an SF-36 survey in the older institutionalized adults
timeFrame: 2 months
Other outcomes:
Locations:
city: Aurora
country: Canada
facility: Kingsway Arms- Aurora Retirement Centre
state: Ontario
Study officials:
affiliation: U of Toronto, Mount Sinai Hospital
name: Reinhold Vieth, PhD,FCACB
role: PRINCIPAL_INVESTIGATOR
affiliation: Aurora Retirement Centre
name: Pierre Geoffroy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.