Falls and vitamin D – another poor study – RCT

Created October 2017

Medium doses of daily vitamin D decrease falls and higher doses of daily vitamin D3 increase falls: A randomized clinical trial

The Journal of Steroid Biochemistry and Molecular Biology, Vol 173, Oct 2017, Pages 317–322, https://doi.org/10.1016/j.jsbmb.2017.03.015

Lynette M. Smitha, J. Christopher Gallagherb, , , Corinna Suiterb

* 8 arms to the study: placebo, 400, 800, 1600, 2400, 3200, 4,000 and 4800 IU* Tiny study: only 19 women in each arm of the study* Apparently half were white women (10)* Apparently less than half of the whites were previously fallers (3)* Apparently 2 falls per year/woman*     Pretty tricky to get good statistics based on a total of 3 falls of 3 white women* Study duration = 1 year* Analysis of falls was for the exact same time period * giving no time to get benefits of increase Vitamin D levels* Black women fell less often with higher Vitamin D doses, including 4,000 IU * Study gives no indication of number of falls vs the study period* Study states that there were more falls for those archiving > 40 ng of vitamin D by the end of the year* No details of falls vs time are provided* Vitamin D Life is well aware of problems with > 40 ng of vitamin D if co-factors are not adjusted* This study had, for example, all participants consume least 1200 mg of Calcium daily* Many other studies minimize Calcium intake: <700 or even <500 mg 1. See also Vitamin D Life* 2X fewer Senior falls in group getting 100,000 IU vitamin D monthly via Meals-on-Wheels – RCT Aug 2015* Vitamin D prevents falls – majority of meta-analyses conclude – meta-meta analysis Feb 2015 * Vitamin A interferes with vitamin D and may be the cause of U shaped relationships – April 2014* Note: the study on this page did not even record the other supplements which were taken* Elderly should not have more than 40 ng of vitamin D (if infrequent dosing or fail to adjust cofactors) Aug 2017* Falls cut in half by 100,000 IU vitamin D monthly - RCT 2016

Highlights

• One year double blind trial, 7 daily oral doses of vitamin D or placebo, on incidence Fallers.

• Faller rate was a U shaped curve, maximum decrease on doses 1600–3200 IU or serum 25OHD of 32–38 ng/ml.

• High vitamin D dose 4000–4800 IU increases Faller incidence in those with previous Fall history.

Falls are a serious health problem in the aging population. Because low levels of vitamin D have been associated with increased fall rates, many trials have been performed with vitamin D; two meta-analyses showed either a small effect or no effect of vitamin D on falls. We conducted a study of the effect of vitamin D on serum 25 hydroxyvitamin D (25OHD) and data on falls was collected as a secondary outcome. In a 12-month double blind randomized placebo trial, elderly women, mean age 66 years , were randomized to one of seven daily oral doses of vitamin D or placebo. The main inclusion criterion for study was a baseline serum 25OHD < 20 ng/ml (50 nmol/L). A history of falls was collected at baseline and fall events were collected every 3 months. Results showed that the effect of vitamin D on falls followed a U-shaped curve whether analyzed by dose or serum 25OHD levels.

  • There was no decrease in falls on low vitamin D doses 400, 800 IU,

  • a significant decrease on medium doses 1600, 2400,3200 IU (p = 0.020) and

  • no decrease on high doses 4000, 4800 IU compared to placebo (p = 0.55).

When compared to 12-month serum 25OHD quintiles, the faller rate was

  • 60% in the lowest quintile <25 ng/ml (<50 nmol/L),

  • 21% in the low middle quintile 32–38 ng/ml (80–95 nmo/L),

  • 72% in the high middle quintile 38–46 ng/ml (95–115 nmo/L) and

  • 45% in the highest quintile 46–66 ng/ml (115–165 nmol/L).

In the subgroup with a fall history , fall rates were

  • 68% on low dose,

  • 27% on medium doses and

  • 100% on higher doses.

Fall rates on high doses were increased compared to medium doses (Odds Ratio 5.6.95% CI: 2.1–14.8).

In summary, the maximum decrease in falls corresponds to a 12- month serum 25OHD of 32–38 ng/ml (80–95 nmol/L) and faller rates increase as serum 25OHD exceed 40–45 ng/ml (100–112.5 nmol/L). The Tolerable upper limit (TUL) recently increased in 2010 from 2000 to 4000 IU/day may need to be reduced in elderly women especially in those with a fall history.