Can Vitamin D Supplementation Reduce the Risk of Fracture in the Elderly? A Randomized Controlled Trial

Paediatric Research Institute (PFI), University of Oslo, Kristiania (historical), Oslo, Norway
Journal of Bone and Mineral Research (Impact Factor: 6.83). 05/2002; 17(4):709-15. DOI: 10.1359/jbmr.2002.17.4.709
Source: PubMed


Randomized controlled trials have shown that a combination of vitamin D and calcium can prevent fragility fractures in the elderly. Whether this effect is attributed to the combination of vitamin D and calcium or to one of these nutrients alone is not known. We studied if an intervention with 10 microg of vitamin D3 per day could prevent hip fracture and other osteoporotic fractures in a double-blinded randomized controlled trial. Residents from 51 nursing homes were allocated randomly to receive 5 ml of ordinary cod liver oil (n = 569) or 5 ml of cod liver oil where vitamin D was removed (n = 575). During the study period of 2 years, fractures and deaths were registered, and the principal analysis was performed on the intention-to-treat basis. Biochemical markers were measured at baseline and after 1 year in a subsample. Forty-seven persons in the control group and 50 persons in the vitamin D group suffered a hip fracture. The corresponding figures for all nonvertebral fractures were 76 persons (control group) and 69 persons (vitamin D group). There was no difference in the incidence of hip fracture (p = 0.66, log-rank test), or in the incidence of all nonvertebral fractures (p = 0.60, log-rank test) in the vitamin D group compared with the control group. Compared with the control group, persons in the vitamin D group increased their serum 25-hydroxyvitamin D concentration with 22 nmol/liter (p = 0.001). In conclusion, we found that an intervention with 10 microg of vitamin D3 alone produced no fracture-preventing effect in a nursing home population of frail elderly people.

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    • "Few studies have examined the relationship between vitamin D supplementation and PTH in Blacks. In a study of 127 postmenopausal Black women randomized to either placebo or 1000 IU of vitamin D supplementation with calcium supplement to bring daily calcium intake to 1000 mg, serum 25(OH)D increased by 100 % in supplement users from a baseline of 11.6 ng/mL and produced a significant decline in PTH at 3 months [34]. In another study of 198 White and African-American women, participants were randomly assigned to placebo or daily vitamin D supplementation and were given calcium to maintain total calcium intake of 1000-1200 mg/d. "
    [Show abstract] [Hide abstract] ABSTRACT: Background: Response of parathyroid hormone (PTH) to vitamin D supplementation is determined by the baseline PTH level and change in vitamin D status. Conflicting reports in Blacks exist on the PTH response to vitamin D to supplementation. Methods: During 3 winters from 2007-2010, 328 healthy Blacks (median age, 51 years) living in Boston, MA were randomized into a 4-arm, double-blind trial for 3 months of placebo, 1000, 2000, or 4000 IU of vitamin D3. PTH was measured in 254 participants at baseline and at the end of vitamin D supplementation period. Results: The differences in PTH between baseline and 3 months were 3.93 pg/mL for those receiving placebo, -3.37 pg/mL for those receiving 1000 IU/d, -6.76 pg/mL for those receiving 2000 IU/d, and -8.99 pg/mL for those receiving 4000 IU/d ( -2.98 pg/mL for each additional 1000 IU/d of vitamin D3; p<0.001). Conclusion: We found a significant decrease in PTH with increasing doses of vitamin D supplementation up to intakes of 4000 IU/d in Blacks. Clinical NCT00585637.
    Full-text · Article · Dec 2015
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    • "The DIPART group conducted a patient-based meta-analysis including 7 large trials on vitamin D with 68500 individuals aged 47 and older [29] : two open design trials [30, 31], one trial with intra-muscular vitamin D, and 4 of the 10 double-blind RCTs included in the 2009 meta-analysis described above (one RCT using intermittent vitamin D2 doses without calcium [32], one RCT with 400 IU of vitamin D3 without calcium [33], one trial with 800 IU of vitamin D3 per day with and without calcium and less than 50% adherence [25], and one trial with 400 IU of vitamin D with calcium [24]). On the basis of the inclusion criteria, a reduced overall risk of fracture (hazard ratio = 0.92; 95% CI 0.86 to 0.99) and a non-significant reduction of hip fractures (hazard ratio = 0.84; 95% CI 0.70 to 1.01) was found for trials that used vitamin D plus calcium. "
    [Show abstract] [Hide abstract] ABSTRACT: Besides its well-known effect on bone metabolism, recent researches suggest that vitamin D may also play a role in the muscular, immune, endocrine, and central nervous systems. Double-blind RCTs support vitamin D supplementation at a dose of 800 IU per day for the prevention of falls and fractures in the senior population. Ecological, case-control and cohort studies have suggested that high vitamin D levels were associated with a reduced risk of autoimmune diseases, type 2 diabetes, cardio-vascular diseases and cancer but large clinical trials are lacking today to provide solid evidence of a vitamin D benefit beyond bone health. At last, the optimal dose, route of administration, dosing interval and duration of vitamin D supplementation at a specific target dose beyond the prevention of vitamin D deficiency need to be further investigated.
    Full-text · Article · Sep 2014
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    • "Older adults are particularly susceptible to vitamin D insufficiency [1] particularly in nursing homes [2]. In Romania, serum 25-hydroxyvitamin D (25(OH)D) concentrations in institutionalized seniors were 28.5 ± 10.8 nmol/L [3], far below the minimum 50 nmol/L that the US Institutes of Medicine has set as the basis for its latest recommended dietary allowance (RDA) [4]. "
    [Show abstract] [Hide abstract] ABSTRACT: We conducted a single-arm clinical trial in institutionalized seniors, on the effects of high-dose vitamin D3-fortified bread daily intake ( registration NCT00789503). At 1 and 3 years after the dietary fortification was stopped, serum 25-hydroxyvitamin D (25(OH)D), parathyroid hormone (PTH) and bone mineral density were measured in 23 of the original study subjects, aged 60-82 years who had consumed bread buns (100 g) fortified with 320 mg elemental calcium and 125 mug (5,000 IU) vitamin D3 daily for one year. At the end of the 1-year supplementation phase (receiving vitamin D3 fortified bread daily), mean (SD) serum 25(OH)D was 127.3 +/- 37.8 nmol/L (baseline for this follow-up). At 1-year follow-up, the serum 25(OH)D was 64.9 +/- 24.8 nmol/L (p = 0.001, vs. baseline); and at 3-year follow-up it was 28.0 +/- 15.0 nmol/L (p = 0.001 vs. baseline). Serum PTH was 18.8 +/- 15.6 pg/ml at baseline while at Year 3 it was 48.4 +/- 18.4 pg/ml (p = 0.001 vs. baseline). Lumbar spine BMD did not change from baseline to Year 3. However, by Year 3, hip BMD had decreased (0.927 +/- 0.130 g/cm2 vs. 0.907 +/- 0.121 g/cm2, p = 0.024). Vitamin D nutritional status exhibits a long half-life in the body, and a true steady-state plateau may not even be reached 1 year after a discontinuation in dose. Furthermore, once the need for vitamin D has been established, based on a low baseline serum 25(OH)D concentrations, the appropriate action is to maintain corrective vitamin D supplementation over the long term.Trial registrationClinical trial registration number: NCT00789503.
    Full-text · Article · Oct 2013 · Nutrition Journal
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