Vitamin D and Falls in Older African American Women: The PODA Randomized Clinical Trial

J Am Geriatr Soc. 2019 May;67(5):1043-1049. doi: 10.1111/jgs.15760. Epub 2019 Jan 30.

Abstract

Background: Limited information is available on the influence of vitamin D on falls in older high-functioning black American women. Endocrine Society guidelines propose serum 25(OH)D levels over 30 ng/mL.

Objective: To determine if maintenance of serum 25(OH)D above 30 ng/mL protects against falls.

Design: The Physical Performance, Osteoporosis and Vitamin D in African American Women (PODA) trial had a prospective, randomized, placebo-controlled, double-dummy design with two arms: one with placebo and one with vitamin D3 adjusted to maintain serum 25(OH)D above 30 ng/mL. The primary outcomes were the prevention of bone loss and the decline in physical performance.

Patients: The target population was healthy black women older than 60 years with serum 25(OH)D between 8 and 26 ng/mL. The trial was 3 years in duration with a falls questionnaire administered every 3 months. A total of 260 women entered the study, and 184 completed the 3 years. Mean age was 68.2 years.

Setting: Research center in an academic health center.

Main outcomes measure: Prevention of falls.

Intervention: Participants were randomly assigned to placebo or active vitamin D. Vitamin D3 dose was adjusted to maintain serum 25(OH)D above 30 ng/mL in the active group using a double-dummy design.

Results: Baseline 25(OH)D was 22 ng/mL. Mean serum 25(OH)D reached 47 ng/mL in the active group compared with 21 ng/mL in the placebo group. There were 14.2% falls in the previous year recalled at baseline. During the study, 46% reported falling in the treatment group compared with 47% in the placebo group. There was no association of serum 25(OH)D or vitamin D dose with the risk of falling.

Conclusions: There is no benefit of maintaining serum 25(OH)D above 30 ng/mL compared with the Institute of Medicine recommendation (20 ng/mL) in preventing falls in healthy older black American women. J Am Geriatr Soc 67:1043-1049, 2019.

Keywords: falls; polypharmacy; race; vitamin D.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Accidental Falls / prevention & control*
  • Accidental Falls / statistics & numerical data
  • Aged
  • Biomarkers / blood
  • Black or African American*
  • Calcifediol / blood*
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Humans
  • Incidence
  • Middle Aged
  • Motor Activity / physiology*
  • Osteoporosis / ethnology*
  • Osteoporosis / prevention & control
  • Prospective Studies
  • United States / epidemiology
  • Vitamin D / therapeutic use*
  • Vitamin D Deficiency / blood*
  • Vitamin D Deficiency / drug therapy
  • Vitamin D Deficiency / ethnology
  • Vitamins / therapeutic use

Substances

  • Biomarkers
  • Vitamins
  • Vitamin D
  • Calcifediol