No registrations found.
ID
Source
Brief title
Health condition
osteoporosis
fracture
cognitive decline
physical performance
quality of life
nutritional status
Sponsors and support
NZO: Dutch Dairy Association
MCO Health
Wageningen University
Erasmus Medical Center
VU University Medical Center
Intervention
Outcome measures
Primary outcome
Fracture 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
Background summary
It 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
Study objective
Supplementation with 500 µg vitamin B12 and 400 µg folic acid reduces fracture incidence in elderly people.
Study design
screening
baseline
final measurements
Intervention
- 500 µg vitamin B12 and 0.4 mg folic acid in one capsule, once per day
- placebo capsule, once per day
P.O. Box 8129
Lisette Groot, de
Gen. Foulkesweg 13
Wageningen 6700 EV
The Netherlands
+31 (0)317 482577 / +31 (0)317 482574
Lisette.deGroot@wur.nl
P.O. Box 8129
Lisette Groot, de
Gen. Foulkesweg 13
Wageningen 6700 EV
The Netherlands
+31 (0)317 482577 / +31 (0)317 482574
Lisette.deGroot@wur.nl
Inclusion criteria
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.
Exclusion criteria
1. 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)
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1287 |
| NTR-old | NTR1333 |
| Other | 6130.0031 : BV PROOF 07/30 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |
Summary results
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. <br>
- Paper with main outcomes:<br>