| - candidate number | 3353 |
| - NTR Number | NTR1333 |
| - ISRCTN | ISRCTN wordt niet meer aangevraagd |
| - Date ISRCTN created | |
| - date ISRCTN requested | |
| - Date Registered NTR | 1-jun-2008 |
| - Secondary IDs | BV PROOF 07/30 6130.0031 |
| - Public Title | Vitamin B12 and Folic Acid Supplementation for Preventing Fractures in Elderly People |
| - Scientific Title | Vitamin B12 and Folic Acid Supplementation for Preventing Fractures in Elderly People |
| - ACRONYM | B-PROOF |
| - hypothesis | Supplementation with 500 µg vitamin B12 and 400 µg folic acid reduces fracture incidence in elderly people. |
| - Healt Condition(s) or Problem(s) studied | Cognitive decline, Osteoporosis, Nutrition, Physical activity, Quality of life, Fracture |
| - Inclusion criteria | 1. 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 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) |
| - mec approval received | yes |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | Double |
| - control | Placebo |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-jul-2008 |
| - planned closingdate | 31-dec-2011 |
| - Target number of participants | 3000 |
| - Interventions | - 500 µg vitamin B12 and 0.4 mg folic acid in one capsule, once per day - placebo capsule, once per day |
| - 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 |
| - Timepoints | screening baseline final measurements |
| - Trial web site | N/A |
| - status | open: patient inclusion |
| - CONTACT FOR PUBLIC QUERIES | PhD. Lisette Groot, de |
| - CONTACT for SCIENTIFIC QUERIES | Dr. 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 | N/A |
| - 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 supplementation with folic acid (400 µg) and vitamin B12 (500 µg ) 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 µmol/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) | |
| - RECORD | 1-jun-2008 - 25-jul-2008 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl