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Pharmacy Times
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Vitamin D supplementation has been studied as a possible intervention for reducing the risk of falls in elderly patients.
A fall is defined as “an event which results in a person coming to rest inadvertently on the ground or floor or other lower level.”1 According to the Centers for Disease Control and Prevention, millions of adults 65 years and older fall each year.2 The number of falls increases with age, regardless of sex and ethnicity3 (Figure). Falls may threaten the independence of elderly adults and lead to substantial financial costs; they can lead to such serious injuries as hip fractures and head traumas, and are the seventh leading cause of death for this age group.4
Worldwide, the proportion of adults 60 years and older is growing faster than any other age group.5 Thus, effective interventions need to be identified to prevent and/or delay falls among the elderly. Vitamin D supplementation has been studied as a possible intervention for reducing this risk.
Vitamin D
The role of vitamin D in fall prevention has been evaluated in multiple trials and is mentioned in various guidelines and organizations. Vitamin D is a fat-soluble vitamin that typically exists in some foods but is also available as a dietary supplement.6 Additionally, it is made by the body once the skin is exposed to UV rays from sunlight .Vitamin D promotes calcium absorption and enables normal bone mineralization by maintaining sufficient serum calcium and phosphate concentrations.6 A positive association between 25-hydroxyvitamin D (25-OHD) levels and lower-extremity musculoskeletal function in older adults has fueled interest to further explore the possible effects on preventing falls.7 Older adults are at a higher risk for vitamin D deficiency, which is commonly defined as serum 25-OHD less than 30 ng/mL. Possible etiologies include less efficient synthesis of vitamin D in the skin, less sun exposure, and a potentially inadequate dietary intake of vitamin D.6
Evidence Review
Per the Institute of Medicine panel, the recommended dietary allowance of vitamin D is 600 IU daily for all ages up to 70 years and 800 IU after the age of 70.8 The United States Preventative Services Task Force recommends exercise or physical therapy and vitamin D supplementation to prevent falls in community-dwelling adults at risk for them (grade B) who are at least 65 years.9 The American Geriatrics Society (AGS) recommends 800 IU/day in older adults with a proven vitamin D deficiency (grade A) and consideration of supplementation in those with suspected vitamin D deficiency or at increased risk for falls (grade B).10 These recommendations are based on trials that have assessed the effects of vitamin D on preventing falls in the elderly. The summary of the guideline recommendations can be found in Table 1. See Table 2 for a summary of the following trials.
Table 1: Summary of Guideline Recommendations on Vitamin D Supplementation
Institution
Recommendation
Institute of Medicine8
2010
Daily dietary allowance:
≤70 years: 600 IU daily
>70 years: 800 IU daily
United States Preventative Services Task Force9
2012
≥65 years, community-dwelling adults: exercise or physical therapy and vitamin D supplementation if at increased risk for falls (grade B)
American Geriatrics Society10
2010
Recommend 800 IU in older adults with proven vitamin D deficiency (grade A)
Consider in older adults with suspected vitamin D deficiency (grade B), increased risk for falls (grade B)
Dukas et al11
This was a 36-week, double-blind, placebo-controlled, randomized trial that studied the effect of 1 mcg of alfacalcidol (vitamin D3 analogue) daily on the number of individuals who fell and falls compared with placebo. The study included 378 community-dwelling adults with an average age of approximately 75 years and baseline 25-OHD level of approximately 29 ng/mL. The primary outcome was the number of individuals in each group who had a fall. Upon adjusting for multiple variables (such as age, sex, and body mass index), alfacalcidol was associated with a nonsignificant number of individuals who fell compared with placebo (OR 0.69; 95% CI, 0.41-1.16). When stratified by reported calcium use, subjects who consumed more than 512 mg of calcium each day in the alfacalcidol group had significant fewer individuals who fell (OR 0.45; 95% CI, 0.21-0.97)
Porthouse et al12
This was a randomized controlled trial of 3314 women 70 years and older with 1 or more risk factors for hip fracture who were randomized into 2 groups: the patients received either (1) 1000 mg of calcium plus 800 IU of vitamin D3 and an informational leaflet on dietary calcium intake and prevention of falls or (2) the leaflet only. No baseline serum 25-OHD levels were taken. The primary outcome was fractures, not including those of digits, rib, face, and skull. Secondary outcome measures included hip fracture, quality of life, visits to the doctor and hospital admissions, death, falls, and fear of falling. There was no significant difference in any of the primary or secondary outcomes.
Bischoff et al13
A 3-year, randomized controlled trial of 445 participants who were assigned to either vitamin D3 (cholecalciferol) 700 IU/day plus calcium citrate malate 500 mg/day or placebo. The groups were stratified according to race, sex, and decade of age. The primary end point of the original trial was bone mineral density. This particular analysis studied the risk of falling at least once during follow-up, which was the secondary outcome of the original trial; the original trial was powered to assess bone mineral density. The average age was approximately 71 years, with a mean 25-OHD of 26.7 ng/mL in women and 33 ng/mL in men. The results for the total sample showed that during the 3-year follow-up period, the cholecalciferol-calcium intervention did not significantly reduce the odds of falling compared with the placebo (OR 0.77; 95% CI, 0.51-1.15); however, when analyzed by sex, the odds of falling in this group were significantly reduced among women (OR 0.54; 95% CI, 0.30-0.97), specifically less active women (OR 0.35; 95% CI, 0.15-0.81). There was no significant reduction among men.
Prince et al14
A 1-year, double-blind, randomized controlled trial included 302 community-dwelling women aged 70 to 90 years living in Perth, Australia. The participants were randomized to receive vitamin D2 (ergocalciferol) 1000 IU/day or placebo, and both groups received calcium citrate 1000 mg/day. The average age of the total sample was approximately 77 years, with a baseline 25-OHD of approximately 18 ng/mL, with height being the only significant difference (P <.05). The primary outcome was the number of falls recorded. After adjusting for differences in height between the 2 groups, there was a significant reduction in the odds of falling in the ergocalciferol group compared with the control group, which equated to a 19% relative risk reduction.
Pfeifer et al15
In this 20-month, double-blind, controlled trial, 242 healthy ambulatory adults 70 years and older were assigned to either elemental calcium 500 mg plus cholecalciferol 400 IU twice daily or elemental calcium 500 mg twice daily (control group). The study treatments were stopped at month 12, and participants were followed for 8 more months. The primary outcome measured was the occurrence of falls recorded by diary. By month 20, 40% of participants had at least 1 fall in the treatment group compared with 63% in the control group (P <.01). This study also assessed quadriceps strength, body sway, and timed-up-and-go (TUG) test. Both TUG and quadriceps strength had a significant difference in favor of the treatment group, but no significant difference in body sway.
Table 2: Summary of Trials Examining the Role of Vitamin D Supplementation in Elderly Fall Prevention
Trial
Average Age (years)
Duration
Treatment Intervention
Outcome
Results
Comments
Dukas et al (2004)11
75
36 weeks
1 mcg alfacalcidol (vitamin D3 analogue) daily vs placebo
Number of fallers
No significant difference (OR 0.69; 95% CI, 0.41-1.16)
Baseline mean 25-OHD: ~ 29 ng/mL; participants mostly from the Basel Study (cohort study since 1959), Basel, Switzerland
Porthouse et al (2005)12
77
2 years (median)
1000 mg calcium plus 800 IU vitamin D3 and information leaflet on dietary calcium intake and prevention of falls or just the leaflet.
Primary outcome: fractures, not including those of digits, rib, face, and skull. Secondary outcomes: hip fracture, quality of life, visits to the doctor and hospital admissions, death, falls and fear of falling.
No significant difference in the primary and secondary outcomes. No significant difference in the odds of a woman falling in the treatment group compared with the control group (OR 0.99; 95% CI, 0.81-1.20).
Baseline 25-OHD not assessed
Bischoff et al (2006)13
71
3 years
700 IU cholecalciferol plus 500 mg calcium citrate malate daily vs placebo
Risk of falling at least once during follow-up
Overall cholecalciferol-calcium intervention did not significantly reduce the odds of falling compared with the placebo (OR 0.77; 95% CI, 0.51-1.15).
Odds of falling in the cholecalciferol-calcium group were significantly reduced among women (OR 0.54; 95% CI, 0.30-0.97). There was no significant reduction among men.
Baseline mean 25-OHD: 26.6 ng/mL (women); 33.2 ng/mL (men)
Prince et al (2008)14
77
1 year
Vitamin D2 1000 IU plus calcium citrate 1000 mg daily vs placebo plus calcium citrate 1000 mg daily
Number of falls
Significant reduction in the odds of falling in the ergocalciferol group compared with the control group; 19% relative risk reduction
At baseline, participants had a history of falling and 25-OHD deficiency (mean 18 ng/mL).
Fall risk reduction was mostly seen in the winter.
Pfeifer et al (2009)15
76.5
20 months
Elemental calcium 500 mg plus 400 IU cholecalciferol twice daily vs elemental calcium 500 mg twice daily
Occurrence of falls (determined by diaries)
Month 12: 27% decrease in number of first falls in the treatment group compared with the control group (P <.01). Month 20: 39% decrease (P <.01)
Baseline 25-OHD: ~21.8 ng/mL
Older adults are more likely to be vitamin D—deficient and have a higher risk for falls. However, due to the various and conflicting results from the trials summarized above, it is difficult to pinpoint the exact role of vitamin D supplementation in fall prevention. Many variables, such as dose, variation in fall reporting, diet, serum vitamin D levels, and geographic location, can make the results challenging to compare and draw conclusions from.
Key Considerations
It is important to consider other factors that could put an older adult at risk for falls, such as medications, low blood pressure, and vision problems (Figure).16 Even though vitamin D is a relatively benign supplement, it is imperative to remember that toxicity is possible because it is a fat-soluble vitamin. Serum levels should be assessed routinely, particularly if a patient is on high-dose vitamin D supplementation. Recommendations should be made after assessing patients individually, as each older adult is unique.
Ms. Noh and Ms. Bonsu are fourth-year pharmacy student at Notre Dame of Maryland University School of Pharmacy. Dr. Rickards is an assistant professor at Notre Dame of Maryland University School of Pharmacy and a geriatric clinical pharmacist.
References