Status:
COMPLETED
How Much Vitamin D is Required to be Protective Against Deficiency During the Winter Months?
Lead Sponsor:
McGill University
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Vitamin D Deficiency
Eligibility:
MALE
70+ years
Phase:
PHASE4
Brief Summary
Vitamin D is essential to bone health. In Canada, it is obtained by sunlight exposure of the skin (between April and October) or by a few foods such as fatty fish, eggs or fortified milk and margarine...
Detailed Description
The main objectives of the proposed 2 phase-protocol in aged Canadian veterans (n=60) are to evaluate the impact of 2000 IU/day of vitamin D3 supplementation (tablets or liquid form) on correcting low...
Eligibility Criteria
Inclusion
- All Veterans over the age of 70 years will be invited to participate given selection and exclusion criteria. Level 1, 2 and 3 care will comprise the recruitment pool. These levels of care permit such investigation and do not include those in palliative conditions.
- Individuals with chronic diseases will be permitted to participate as long as the disease is not end-stage (ie prognosis of more than 4 months).
- Not excluding co-morbidities or poor cognition is consistent with the work of others in the area.
- Lastly combined oral and enteral feeding modes will be included since the majority quickly transition to foods but some do take a meal-replacement/liquid supplement.
Exclusion
- End-stage renal disease due to altered vitamin D metabolism and use of vitamin D analogues
- End-stage liver disease
- Untreated hyperparathyroid conditions such as cancer and metabolic bone disease except for osteoporosis and osteomalacia
- Any condition that requires enteral feeding alone as feeding route will be excluded since this oral intake, even if only partial, is a critical measurement.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT01437696
Start Date
October 1 2011
End Date
May 1 2014
Last Update
September 5 2014
Active Locations (1)
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1
Ste. Anne's Hospital
Ste. Anne-de-Bellevue, Quebec, Canada, H9X1Y9