Status:
UNKNOWN
Vitamin B12 and Folic Acid Supplementation for Preventing Fractures in Elderly People
Lead Sponsor:
Wageningen University
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
MCO Health
Conditions:
Osteoporosis
Cognitive Decline
Eligibility:
All Genders
65+ years
Phase:
PHASE1
Brief Summary
It is hypothesized that vitamin B12 and folic acid supplementation reduces the number of incident fractures. The proposed study, a randomized placebo-controlled intervention trial, compares daily supp...
Detailed Description
Rationale: There is growing evidence that an elevated homocysteine level is a risk factor for fracture incidence. The most common cause of homocysteine elevation is poor vitamin B12 and folate status....
Eligibility Criteria
Inclusion
- 65 years and older; based on entry date into study;
- Fasting plasma Hcy level \>= 12 µmol/L and \< 50 µmol/L;
- No current or recent (\<4 months) use of supplements with very high doses of B-vitamins;
- Competent to make own decisions;
- Persons with skin cancer are allowed to participate.
- Compliance to tablet intake \> 85%
Exclusion
- Participation in other intervention trials;
- Serious medical conditions, e.g. cancer diagnosis within the last 5 years or recent myocardial infarction;
- Immobilization (bedridden, wheelchair bound);
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2013
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT00696514
Start Date
September 1 2008
End Date
March 1 2013
Last Update
August 25 2011
Active Locations (3)
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1
VU University Amsterdam, Institute for Health Sciences
Amsterdam, Netherlands
2
Erasmus MC
Rotterdam, Netherlands, 3015 GD
3
Wageningen University
Wageningen, Netherlands