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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 µg vitamin B12 and 400 µg 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 µmol/L and < 50 µmol/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 µg 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
- statusstopped: trial finished
- 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
- Publications- Design paper:
Van Wijngaarden JP, Dhonukshe-Rutten RAM, van Schoor NM, van der Velde N, Swart KMA, Enneman AW, van Dijk SC, Brouwer-Brolsma EM, Zillikens MC, van Meurs JBJ, Brug J, Uitterlinden AG, Lips P, de Groot LCPGM. Rationale and design of the B-PROOF study, a randomized controlled trial on the effect of supplemental intake of vitamin B12 and folic acid on fracture incidence. BMC Geriatr 2011;11:80 - Van Wijngaarden JP, Swart KMA, Enneman AW, Dhonukshe- Rutten, van Dijk SC, Brouwer-Brolsma EM, van der Zwaluw NL, Sohl E, van Meurs JBJ, Zillikens MC, van Schoor NM, van der Velde N, Brug J, Uitterlinden AG, Lips P, de Groot LCPGM. Effect of daily vitamin B12 and folic acid supplementation on fracture incidence in elderly with an elevated plasma homocysteine level: B-PROOF, a randomized controlled trial. Am J Clin Nutr 2014; 100(6):1578-1586.
- Paper with main outcomes:
- Brief summaryIt is hypothesized that vitamin B12 and folic acid supplementation reduces the number of incident fractures. The B-PROOF study, a randomized placebo- controlled intervention trial, compares daily supplementation with folic acid (400 µg) and vitamin B12 (500 µg ) to a placebo for a period of two years or longer in 2919 men and women aged 65 years and older, with initial basal plasma total homocysteine (tHcy) levels ≥ 12 µmol/L. Fracture incidence and time to fracture were assessed and used as the efficacy measure.
The data showed that combined vitamin B12 and folic acid supplementation had no effect on osteoporotic fracture incidence in this elderly population. Exploratory subgroup analyses suggest a beneficial effect on osteoporotic fracture prevention in compliant persons aged .80 y. However, treatment was also associated with increased incidence of cancer, although the study was not designed for assessing cancer outcomes. Therefore, vitamin B-12 plus folic acid supplementation cannot be recommended at present for fracture prevention in elderly people
- Main changes (audit trail)18-okt-2015:

The inclusion criteria regarding cut-off values for plasma homocysteine concentrations and age were adapted during the first phase of the intervention. The initial eligibility criterion for plasma homocysteine concentrations has been adjusted from ≥ 15 μmol/L to ≥ 12 μmol/L. The age criterion was adjusted from 70 years and older to 65 years and older after the first year of recruitment.

Inclusion criteria NEW:
1. 65 years and older; based on entry date into study;
2. Fasting plasma Hcy level >= 12 µmol/L and < 50 µmol/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%;
7. Serum creatinine >150 µmol/L.
- RECORD1-jun-2008 - 18-okt-2015


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