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Vitamin D supplementation to prevent falls: Good overall account of a preliminary trial

WINSTON-SALEM, N.C. – Aug. 17, 2015 – Every year falls affect approximately one in three older adults living at home, with approximately one in 10 falls resulting in serious injury. Even if an injury does not occur, the fear of falling can lead to reduced activity and a loss of independence.

Research has shown that vitamin D plays a key role in maintaining muscle integrity and strength and some studies suggest vitamin D may reduce the risk of falls.

Homebound elderly, a generally vulnerable population due to poor dietary intake and nutrition-related health conditions as well as decreased exposure to sunlight, are at increased risk for low vitamin D levels, possibly leading to more falls.

Researchers at Wake Forest Baptist Medical Center set out to evaluate the feasibility of delivering a vitamin D supplement through a Meals-on-Wheels (MOW) program to improve the clients’ vitamin D levels and reduce falls.

The study is published in the early online edition (8/16/2015) of the Journal of the American Geriatrics Society.

“Falls in homebound older people often lead to disability and placement in a nursing home,” said Denise Houston, Ph.D., R.D., associate professor of gerontology and geriatric medicine at Wake Forest Baptist and lead author of the study. “One or our aging center’s goals is to help people maintain their independence and live safely at home for as long as possible.”

Participants in the Meals-on-Wheels program in Forsyth County, North Carolina, were recruited to take part in a five-month, single-blind randomized trial.

Sixty-eight study participants received either a monthly vitamin D supplement of 100,000 international units or placebo delivered with their MOW meal. The study included the participants’ history of falls and their fear of falling, blood tests at the beginning and at end of the trial to measure 25-hydroxyvitamin D (biomarker for vitamin D in blood), and a monthly diary recording falls during the trial period.

At the beginning of this pilot study, the research team found that more than half of the participants had insufficient concentrations of vitamin D in the blood (less than 20 ng/ml), while less than a quarter had concentrations in the optimal range (30 ng/ml or more).

The study showed that the monthly vitamin D supplement was effective in increasing the concentrations of vitamin D in the blood from insufficient to sufficient levels in all but one of the 34 people who received it, and to optimal levels in all but five people. In addition, people in the vitamin D group reported approximately half the falls of those in the control group.

“Although these initial findings are encouraging, we need to confirm the results in a larger trial,” Houston said.

The Wake Forest Baptist team currently is conducting a clinical trial to try to determine how vitamin D affects risk factors for falls such as balance and muscle strength and power.

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Funding for the study was provided by the Wake Forest Translational Science Institute and Center for Integrative Medicine and the Claude Pepper Older Americans Independence Center of Wake Forest Baptist.

Co-authors are Janet Tooze, Ph.D., Jamehl Demons, M.D., Brooke Davis, M.S., Rachel Shertzer-Skinner, M.A., Stephen Kritchevsky, Ph.D., and Jeff Williamson, M.D., of Wake Forest Baptist; and Linda Kearsley, B.S., Senior Services Inc., Winston-Salem.

Vitamin D supplements could help reduce falls in homebound elderly

Our Review Summary

senior fallThis release started out very strong in describing the major findings of a study of vitamin D for preventing falls — an issue of critical importance to the nation’s growing universe of senior citizens and the people who care for them. The release offers a clear summary of the problem and intervention.  It also describes the intermediate endpoint (raising vitamin D levels) and the clinically important endpoint (falls). It would have been stronger if it had given the absolute reduction in fall risk (we need to know the fall rate in the control or intervention group to figure out how important the 50% reduction mentioned in the story would be), discussed cost and harm, and told us more about prior similar research.

 

Why This Matters

More than a third of home-bound older adults fall in any given year, and about one in 10 of those falls results in serious injury that can result in disability, placement in long-term care or death, according to a 2003 New England Journal of Medicine study. If Vitamin D supplementation via Meals on Wheels can reduce that risk, that would be important information that could help guide this vulnerable population and their caregivers. Although we have some interventions to reduce falls (e.g. balance programs), simple ways to reduce risk like vitamin supplementation are also important.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

The news release makes no mention of the cost of Vitamin D supplements, which would likely be important to the elderly population, many of whom live on fixed incomes. Nor does it mention a key fact about the Older Americans Act that was cited in the study itself: “Although OAA nutrition programs can provide education and counseling to encourage the use of vitamin-mineral supplements, the provision of vitamin-mineral supplements is currently not a fundable OAA service.” Relatively speaking, the cost of such supplements is minimal, but readers may not be aware of that.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

On the positive side, the release notes that participants in the vitamin D group had higher blood levels of the vitamin and tells us how many achieved “sufficient” and “optimal” levels. It provides the cutoffs that were used to determine those outcomes.

However, with respect to the key clinical outcome — falls — the story says, “people in the vitamin D group reported approximately half the falls of those in the control group.” It’s not clear from this description how many falls were actually prevented. The study itself clarifies this in absolute terms: “The mean number of reported falls over the 5-month follow-up period was 0.5 (range 0–
4) in participants randomized to vitamin D3 and 1.1 (range 0–8) in participants randomized to active placebo.”

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

The release makes no mention of possible harms caused by Vitamin D supplements, though the FDA website cites a laundry list of concerns that it attributes to the American Association of Family Physicians: Nausea, vomiting, poor appetite, constipation, weakness, weight loss, confusion, heart rhythm problems, deposits of calcium and phosphate in soft tissues.

Does the news release seem to grasp the quality of the evidence?

Satisfactory

The release makes it clear that this was a randomized placebo-controlled trial and explained the purpose and delivery of the vitamin. It also closes with a restraining comment from one of the study researchers: “Although these initial findings are encouraging, we need to confirm the results in a larger trial,” Houston said. We’ll call that good enough for a Satisfactory rating here.

Does the news release commit disease-mongering?

Satisfactory

The news release did not appear to exaggerate the severity of the problem.

Does the news release identify funding sources & disclose conflicts of interest?

Satisfactory

The news release cites funding sources. It makes no mention of possible conflicts of interest, but the study itself says none were found.

Does the news release compare the new approach with existing alternatives?

Not Satisfactory

Neither the news release nor the study makes any mention of other possible interventions that might result in fewer or less-serious falls. For example, balance programs such as Tai Chi are known to decrease fall risk. Other steps that may help include the installation of hand rails, the use of carpeting on steps, the use of bright-colored tape on steps to increase depth perception, etc.

Does the news release establish the availability of the treatment/test/product/procedure?

Not Applicable

We’ll rate this Not Applicable. Although no mention was made of the availability of the vitamin supplements, it is fair to assume most readers know that they are readily available in nearly any supermarket or drug store. However, the high dose vitamin D used in this study is typically available by prescription only.

Does the news release establish the true novelty of the approach?

Not Satisfactory

The news release says that “some studies suggest vitamin D may reduce the risk of falls,” but this area has been more thoroughly studied than this statement would suggest. On the basis of available research summarized in a systematic review, the U.S. Preventive Services Task Force recommends vitamin D supplementation in community-dwelling adults aged 65 years or older who are at increased risk for falls.

In addition, the study authors state that they believe their work to be the first such study conducted in homebound older adults — an important statement of novelty. The release doesn’t mention this.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Satisfactory

The news release does not use language that goes beyond what the study itself justifies.

Total Score: 4 of 9 Satisfactory

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