title: Effectiveness of Calcifediol in Improving Muscle Function in Post-Menopausal Women: A Prospective Cohort Study.
abstract: The role of vitamin D supplementation on muscle function and physical performance is still debated. Calcifediol is an available treatment for hypovitaminosis D, particularly for extra-skeletal effects. Aim of this prospective cohort study was to evaluate the effectiveness of calcifediol on serum levels of 25(OH)D3, appendicular muscle strength, physical performance, and prevention of falls in post-menopausal women.
  
  
  
  We recruited post-menopausal women aged ≥50 years, referring to an outpatient service for the management of osteoporosis over a 18-month period. We included women with a diagnosis of osteoporosis and/or vitamin D deficiency [serum levels of 25(OH)D3<30 ng/ml]. All the participants received calcifediol (20 μg, 4 oral drops/day) for a 6-month period. We evaluated at the baseline and after 6 months the following outcomes: serum levels of 25(OH)D3, appendicular muscle strength, using the Isometric Hand Grip Strength Test and the Knee Isometric Extension Strength Test, physical performance, using the Short Physical Performance Battery (SPPB) and the 4-m gait speed (4MGS), and the risk of falls (percentage of fallers and recurrent fallers and mean number of falls). A sub-analysis was performed in patients with vitamin D deficiency.
  
  
  
  We enrolled 113 post-menopausal women, mean aged 68.01 ± 9.13 years. After 6 months of treatment, there was a significant increase in serum levels of 25(OH)D3(p < 0.001), appendicular muscle strength (p < 0.001), and physical performance (p = 0.002 at SPPB and p = 0.010 at 4MGS, respectively). At 6 months, the percentage of fallers was lower, although not significantly (p = 0.078), whereas there was a significant reduction both in percentage of recurrent fallers and in the mean number of falls (p < 0.001 and p = 0.020, respectively).
  
  
  
  Calcifediol was significantly effective in improving serum levels of 25(OH)D3and muscle function and in reducing the percentage of recurrent fallers and the mean number of falls in a cohort of post-menopausal women.
authors.affiliation: Department of Medical and Surgical Specialties and Dentistry, University of Campania "Luigi Vanvitelli", Naples, Italy. giovanni.iolascon@gmail.com.
authors.forename: Giovanni
authors.identifier: 0000-0002-0976-925X
authors.initials: G
authors.lastname: Iolascon
authors.affiliation: Department of Medical and Surgical Specialties and Dentistry, University of Campania "Luigi Vanvitelli", Naples, Italy.
authors.forename: Antimo
authors.initials: A
authors.lastname: Moretti
authors.affiliation: Department of Medical and Surgical Specialties and Dentistry, University of Campania "Luigi Vanvitelli", Naples, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: de Sire
authors.affiliation: Department of Medical and Surgical Specialties and Dentistry, University of Campania "Luigi Vanvitelli", Naples, Italy.
authors.forename: Dario
authors.initials: D
authors.lastname: Calafiore
authors.affiliation: Department of Mental and Physical Health and Preventive Medicine, University of Campania "Luigi Vanvitelli", Naples, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Gimigliano
mesh_terms: D000058:Accidental Falls / Q000517:prevention & control*; D000368:Aged; D050071:Bone Density Conservation Agents / Q000008:administration & dosage; D002112:Calcifediol / Q000008:administration & dosage / Q000378:metabolism; D019587:Dietary Supplements; D005260:Female; D018737:Hand Strength / Q000502:physiology*; D006801:Humans; D008875:Middle Aged; D010809:Physical Fitness / Q000502:physiology*; D017698:Postmenopause / Q000187:drug effects / Q000502:physiology; D011446:Prospective Studies; D055948:Sarcopenia / Q000209:etiology / Q000378:metabolism / Q000517:prevention & control*; D014808:Vitamin D Deficiency / Q000150:complications / Q000175:diagnosis
chemical_list: D050071:Bone Density Conservation Agents; D002112:Calcifediol
keywords: Calcifediol; Falls; Muscle strength; Orthopedics; Physical performance; Sarcopenia; Vitamin D; Vitamin D deficiency