Vitamin D Fortified Cheese and Well-being in the Institutionalized Elderly
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University of Toronto.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University of Toronto
Information provided by (Responsible Party):
Reinhold Vieth, University of Toronto
ClinicalTrials.gov Identifier:
NCT01555424
First received: March 13, 2012
Last updated: March 14, 2012
Last verified: March 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
The Focus is to Assess 25-hydroxyvitamin D Levels and Well-being |
Dietary Supplement: High dose Dietary Supplement: Reference dose |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) |
| Official Title: | Bioavailability of Casein-bound Vitamin D From Fortified Cheese and Its Effects on the Well-being of the Institutionalized Elderly |
Resource links provided by NLM:
Further study details as provided by University of Toronto:
Primary Outcome Measures:
- The bioavailability of vitamin D from cheddar cheese fortified with vitamin D, in older institutionalized adults [ Time Frame: 2 months ] [ Designated as safety issue: No ]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:
- A change in wellbeing scores using an SF-36 survey in the older institutionalized adults [ Time Frame: 2 months ] [ Designated as safety issue: No ]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.
| Enrollment: | 28 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | April 2012 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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).
|
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| Ages Eligible for Study: | 70 Years and older (Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01555424
Please refer to this study by its ClinicalTrials.gov identifier: NCT01555424
Locations
| Canada, Ontario | |
| Kingsway Arms- Aurora Retirement Centre | |
| Aurora, Ontario, Canada, L4G 2C7 | |
Sponsors and Collaborators
University of Toronto
Investigators
| Principal Investigator: | Reinhold Vieth, PhD,FCACB | U of Toronto, Mount Sinai Hospital |
| Principal Investigator: | Pierre Geoffroy, MD | Aurora Retirement Centre |
More Information
Publications:
| Responsible Party: | Reinhold Vieth, Dr., University of Toronto |
| ClinicalTrials.gov Identifier: | NCT01555424 History of Changes |
| Other Study ID Numbers: | M2327 |
| Study First Received: | March 13, 2012 |
| Last Updated: | March 14, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of Toronto:
|
25-hydroxyvitamin D Institutionalized seniors SF-36 survey Winter |
Additional relevant MeSH terms:
|
Vitamins Vitamin D Ergocalciferols Micronutrients |
Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on September 28, 2016