Table 1 |
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Studies that failed to demonstrate any significant effect of vitamin D and/or calcium supplementation on fall and bone fracture rate reduction in the elderly |
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Study |
Primary objective |
Study plan |
Population |
Supplementation |
Results |
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|
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Latham et al. 2003 [9] |
- I Prevention area and II area |
- Multicenter, randomized, controlled trial with a factorial design |
- N = 243 |
- Vitamin D: |
- No reduction of the fall rate |
|
- Falls |
- Mean follow-up: 6 months |
- Mean age = 79.1 ± 6.9 years |
Calciferol Dose: 300,000 IU Per os |
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- Women: 53% |
- Compliance: 100% |
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- Subjects: |
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Frail hospitalized History of falls in previous year: 56% Mean 25(OH)D3 at entry = 17 ng/mL |
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Smith HE et al. 2004 [10] |
- Primary prevention |
- Randomized, controlled, double-blind trial |
- N = 9,440 |
- Vitamin D: |
- No significant reduction of fracture risk (OR = 1.10; [0.94-1.29] |
|
- Non-vertebral fractures |
- Mean follow-up: 3 years |
- Age > 75 years |
Ergocalciferol (D2) Dose/year: 300,000 IU IM |
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- Women living at home |
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Porthouse J et al. 2005 [11] |
- Secondary prevention |
Randomized, controlled, open-label trial |
- N = 3,314 (1,993 controls and 1,321 intervention) |
- Vitamin D: |
- No significant risk reduction: |
|
- Vertebral or long bone fracture |
- Mean follow-up: 2 years |
- Mean age: (76.5 ± 5.0 control and 77.0 ± 5.1 intervention) |
Cholecalciferol (D3) Dose/day: 800 IU Per os |
Fractures (OR = 1.01; [0.71-1.43] Falls (OR = 0.99 [0.81-1.20] at 6 months; OR = 0.98 [0.79-1.20] at 12 months |
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|
- Women: |
- Calcium: 1000 mg/day |
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Living at home With one or more risk factors for hip fracture History of falls: 34% |
- Compliance: 63% at 12 months and 55% at 24 months |
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Grant AM et al. 2005 [12] |
- Secondary prevention |
- Randomized, controlled, double-blind trial |
- N = 5,292 (1,332 controls and 1,311 calcium, 1,343 vitamin D and 1,306 Vitamin D and calcium) |
- Vitamin D: |
- No significant risk reduction: |
|
- Vertebral or non-vertebral fractures |
- Mean follow-up: 2 years |
- Mean age |
Cholecalciferol (D3) Dose/day: 800 IU Per os |
Fractures (OR = 0.94; [0.81-1.09] for calcium) (OR = 1.02; [0.88-1.19] for vitamin D) (OR = 1.01; [0.75-1.36] for the Vitamin D and calcium combination) |
|
|
- Women: |
- Calcium: 1000 mg/day |
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Living at home With one or more risk factors for hip fracture History of falls: 34% |
- Compliance: 54.5% at 24 months |
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Jackson RD et al. 2006 [13] |
- I Prevention area and II area |
- Randomized trial, controlled, double blinds |
- N = 36,282 (18,106 controls and 18,176 intervention) |
- Vitamin D: |
- No reduction of the fracture risk (OR = 0, 96; [0.91-1.02] |
|
- Vertebral fracture or long bone |
- Mean follow-up 7 years |
- Mean age (62.4 ± 6.9 years control subjects and 62.4 ± 7.0 years for intervention subjects) |
Cholecalciferol (D3) Dose/day: 400 IU Per os |
No effect of serum vitamin D3 level |
|
|
- Women: |
- Calcium: 1000 mg/day |
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Living at home In good health Post-menopausal osteoporosis History of falls: 39% |
- Compliance: 63% at 3 years and 59% at 7 years |
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Law M et al. 2006 [14] |
- I Prevention area and II area |
- Randomized trial, controlled, opened |
- N = 3,717 (1,955 controls and 1,762 intervention) |
- Vitamin D: |
- No reduction of the rate of falls or the incidence of fractures. |
|
- Vertebral fracture and long bone, and fall |
- Mean follow-up 10 months |
- Mean age of 2 groups 85 years |
Ergocalciferol (D2) Dose/3 months: 1,100 IU Per os |
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- 76% of women in each group |
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- Subjects: |
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> 60 years Institutionalized |
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Lyons RA et al. 2007 [15] |
- I Prevention area and II area |
- Randomized trial, controlled, double blinds |
- N = 3,440 (1,715 controls and 1,725 intervention) |
- Vitamin D: |
- No reduction of the incidence of fractures |
|
- Vertebral or non-vertebral fractures |
- Mean follow-up 3 years |
- Mean age (84 ± 7.4 years control subjects and 84 ± 7.6 years for intervention subjects) |
Ergocalciferol (D2) Dose/4 months: 100,000 IU Per os |
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- 76% of women |
- Compliance: 80% at 3 years |
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- Subjects: |
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Institutionalized |
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Annweiler et al. Journal of NeuroEngineering and Rehabilitation 2010 7:50 doi:10.1186/1743-0003-7-50 |
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