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Vitamin B12 and Folic Acid Supplementation for Preventing Fractures in Elderly People


- candidate number3353
- NTR NumberNTR1333
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-jun-2008
- Secondary IDsBV PROOF 07/30 6130.0031
- Public TitleVitamin B12 and Folic Acid Supplementation for Preventing Fractures in Elderly People
- Scientific TitleVitamin B12 and Folic Acid Supplementation for Preventing Fractures in Elderly People
- ACRONYMB-PROOF
- hypothesisSupplementation with 500 g vitamin B12 and 400 g folic acid reduces fracture incidence in elderly people.
- Healt Condition(s) or Problem(s) studiedCognitive decline, Osteoporosis, Nutrition, Physical activity, Quality of life, Fracture
- Inclusion criteria1. 70 years and older; based on entry date into study;
2. Fasting plasma Hcy level >= 15 mol/L and < 50 mol/L;
3. No current or recent (<4 months) use of supplements with very high doses of B-vitamins;
4. Competent to make own decisions;
5. Persons with skin cancer are allowed to participate.
6. Compliance to tablet intake > 85%
- Exclusion criteria1. Participation in other intervention trials;
2. Serious medical conditions, e.g. cancer diagnosis within the last 5 years or recent myocardial infarction;
3. Immobilization (bedridden, wheelchair bound)
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2008
- planned closingdate31-dec-2011
- Target number of participants3000
- Interventions- 500 g vitamin B12 and 0.4 mg folic acid in one capsule, once per day
- placebo capsule, once per day
- Primary outcomeFracture incidence
- Secondary outcome- falls
- quantitative ultrasound (QUS)
- bone turnover
- BMD
- incidence of cardiovascular events or diagnosis of cancer
- physical performance
- cognitive decline
- quality of life
- Timepointsscreening
baseline
final measurements
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESPhD. Lisette Groot, de
- CONTACT for SCIENTIFIC QUERIESDr. Ir. R.A.M. Dhonukshe-Rutten
- Sponsor/Initiator Wageningen University, Division of Human Nutrition
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center, ZON-MW, The Netherlands Organization for Health Research and Development, VU University Medical Center, Dutch Dairy Association (NZO), MCO Health, Wageningen University
- PublicationsN/A
- Brief summaryIt 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 supplementation with folic acid (400 g) and vitamin B12 (500 g ) to a placebo for a period of two years or longer in 3000 men and women aged 70 years and older, with initial basal plasma total homocysteine (tHcy) levels ≥ 15 mol/L. Fracture incidence and time to fracture will be assessed and used as the efficacy measure.
Metabolic studies in a sub sample of the population will be included aiming to contribute to an understanding of the biological mechanisms underlying the associations found between markers of B-vitamin status and bone quality.
- Main changes (audit trail)
- RECORD1-jun-2008 - 25-jul-2008


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