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

NCT01555424 | Unknown

• 1 other identifier: M2327
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

25-hydroxyvitamin D; Institutionalized seniors; SF-36 survey; Winter

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• A change in wellbeing scores using an SF-36 survey in the older institutionalized adults

  2 months

Study Arms (2)

High dose

ACTIVE COMPARATOR

Dietary Supplement: High dose

Reference dose

ACTIVE COMPARATOR

Dietary Supplement: Reference dose

Interventions

High dose 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).

High dose

Reference dose 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).

Reference dose

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

Kingsway Arms- Aurora Retirement Centre

Aurora, Ontario, L4G 2C7, Canada

Location

Related Publications (2)

• 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.

  PMID: 18567762 BACKGROUND

• 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.

  PMID: 15260882 BACKGROUND

Study Officials

• Reinhold Vieth, PhD,FCACB

  U of Toronto, Mount Sinai Hospital

  PRINCIPAL INVESTIGATOR

• Pierre Geoffroy, MD

  Aurora Retirement Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 13, 2012
• First Posted: March 15, 2012
• Study Start: February 1, 2012
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: March 15, 2012

Record last verified: 2012-03

Locations

CA (1)