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| Name | Class |
|---|---|
| University of Ulster | OTHER |
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An intervention study to investigate the effect of B-vitamin supplementation for 2-years on bone health. This is a dual centre (UCD and University of Ulster) 2-year randomised, placebo controlled, double blind intervention.
Osteoporosis is a major public health issue, especially among older adults. The condition is widespread, with an estimated 1 in 2 women and 1 in 5 men over the age of 50 years expected to have an osteoporotic fracture. The associated health care costs are considerable and growing as the population of older adults increases. Furthermore, osteoporotic fractures are associated with loss of independence and risk of further fractures and health problems for the individual. Given these negative impacts, new approaches to help maintain better bone health in older age are urgently needed.
Vitamin D and calcium have well established protective roles, however, other evidence links certain B vitamins with bone health. This study will investigate the effect of B-vitamin supplementation over a two year period at two centres (UCD and University of Ulster)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Active Comparator | Supplementation for 2 years with one of the following treatments in capsule form: Treatment group will receive: B vitamins + vitamin D, a daily capsule containing 200 µg/day folic acid, 10 µg/day vitamin B12, 10 mg/day vitamin B6 and 5 mg/day riboflavin, and 10 µg/day vitamin D combined |
|
| Control group | Placebo Comparator | Supplementation for 2 years with one of the following treatments in capsule form: Control group will receive: Vitamin D, a daily capsule containing 10 µg/day vitamin D |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B-vitamin supplementation on bone health | Dietary Supplement | An intervention study to investigate the effect of B-vitamin supplementation for 2-years on bone health |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of low dose B vitamins on bone mineral density | A 2 year Randomized Control Trial (RCT) to investigate the effect of low dose B vitamins on bone mineral density (as measured by dual energy X-ray absorptiometry- DXA) in older Irish adults with sub-optimal B-vitamin status at baseline. A DXA bone scan will be performed pre and post the 2-year intervention to evaluate beneficial effects to bone mineral density | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolomics | Metabolomics analysis of blood samples collected pre and post the trial to explore the mechanistic effects of B- vitamins on bone and other outcomes | 2 years |
| Neurocognitive function I |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lorraine Brennan, PhD | University College Dublin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University College Dublin | Dublin | Dublin 4 | D4 | Ireland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36128889 | Result | Clements M, Heffernan M, Ward M, Hoey L, Doherty LC, Hack Mendes R, Clarke MM, Hughes CF, Love I, Murphy S, McDermott E, Grehan J, McCann A, McAnena LB, Strain JJ, Brennan L, McNulty H. A 2-Year Randomized Controlled Trial With Low-Dose B-Vitamin Supplementation Shows Benefits on Bone Mineral Density in Adults With Lower B12 Status. J Bone Miner Res. 2022 Dec;37(12):2443-2455. doi: 10.1002/jbmr.4709. Epub 2022 Oct 14. |
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Supplementation for 2 years with one of the following treatments in capsule form:
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2 year randomised, placebo controlled, double blinded intervention
| Control group; Vitamin D, a daily capsule containing 10 µg/day vitamin D | Dietary Supplement | Vitamin D, a daily capsule containing 10 µg/day vitamin D |
|
To determine the neurocognitive function using the Mini Mental State Exam 'MMSE' test (pre- and post-intervention)
| 2 years |
| Neurocognitive function II | To determine the neurocognitive function using the Repeatable Battery for the Assessment of Neuropsychological Status 'RBANS' test (pre- and post-intervention) | 2 years |
| Neurocognitive function III | To determine the neurocognitive function using the Frontal Assessment Battery 'FAB' test (pre- and post-intervention) | 2 years |
| Gut microbiome | To collect faecal samples pre and post intervention to explore potential interactions with the gut microbiome | 2 years |
| Blood pressure | To measure blood pressure throughout the study and compare baseline to post intervention | 2 years |
| ID | Term |
|---|---|
| D035061 | Control Groups |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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