title: Vitamin D supplementation in older people (VDOP): Study protocol for a randomised controlled intervention trial with monthly oral dosing with 12,000 IU, 24,000 IU or 48,000 IU of vitamin D₃.
abstract: The randomised, double blind intervention trial 'Optimising Vitamin D Status in Older People' (VDOP) will test the effect of three oral dosages of vitamin D given for one year on bone mineral density (BMD) and biochemical markers of vitamin D metabolism, bone turnover and safety in older people. VDOP is funded by Arthritis Research UK, supported through Newcastle University and MRC Human Nutrition Research and sponsored by the Newcastle upon Tyne Hospitals NHS Foundation Trust.a
  
  
  BACKGROUND
  Vitamin D insufficiency is common in older people and may lead to secondary hyperparathyroidism, bone loss, impairment of muscle function and increased risk of falls and fractures. Vitamin D supplementation trials have yielded conflicting results with regard to decreasing rates of bone loss, falls and fractures and the optimal plasma concentration of 25 hydroxy vitamin D (25OHD) for skeletal health remains unclear.
  
  
  METHODS
  Older (≥70 years) community dwelling men and women are recruited through General Practices in Northern England and 375 participants are randomised to take 12,000 international units (IU), 24,000 IU or 48,000 IU of vitamin D3 orally each month for one year starting in the winter or early spring. Hip BMD and anthropometry are measured at baseline and 12 months. Fasting blood samples are collected at baseline and three-month intervals for the measurement of plasma 25OHD, parathyroid hormone (PTH), biochemical markers of bone turnover and biochemistry to assess the dose-response and safety of supplementation. Questionnaire data include falls, fractures, quality of life, adverse events and outcomes, compliance, dietary calcium intake and sunshine exposure.
  
  
  CONCLUSIONS
  This is the first integrated vitamin D supplementation trial in older men and women using a range of doses given at monthly intervals to assess BMD, plasma 25OHD, PTH and biochemical markers of bone turnover and safety, quality of life and physical performance. We aim to investigate the vitamin D supplementation and plasma 25OHD concentration required to maintain bone health and to develop a set of biochemical markers that reflects the effect of vitamin D on bone. This will aid future studies investigating the effect of vitamin D supplementation on fracture risk.#ISRCTN 35648481 (assigned 16 August 2012), EudraCT 2011-004890-10.
authors.affiliation: MRC Human Nutrition Research, Elsie Widdowson Laboratory, Fulbourn Road, Cambridge CB1 9NL, UK. Inez.Schoenmakers@mrc-hnr.cam.ac.uk.
authors.forename: Inez
authors.initials: I
authors.lastname: Schoenmakers
authors.forename: Roger M
authors.initials: RM
authors.lastname: Francis
authors.forename: Elaine
authors.initials: E
authors.lastname: McColl
authors.forename: Thomas
authors.initials: T
authors.lastname: Chadwick
authors.forename: Gail R
authors.initials: GR
authors.lastname: Goldberg
authors.forename: Christine
authors.initials: C
authors.lastname: Harle
authors.forename: Alison
authors.initials: A
authors.lastname: Yarnall
authors.forename: Jennifer
authors.initials: J
authors.lastname: Wilkinson
authors.forename: Jennie
authors.initials: J
authors.lastname: Parker
authors.forename: Ann
authors.initials: A
authors.lastname: Prentice
authors.forename: Terence
authors.initials: T
authors.lastname: Aspray
mesh_terms: D000284:Administration, Oral; D000367:Age Factors; D000368:Aged; D015415:Biomarkers / Q000097:blood; D015519:Bone Density / Q000187:drug effects; D016723:Bone Remodeling / Q000187:drug effects; D001842:Bone and Bones / Q000187:drug effects* / Q000378:metabolism; D002762:Cholecalciferol / Q000008:administration & dosage* / Q000627:therapeutic use; D019587:Dietary Supplements; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004739:England; D005260:Female; D006801:Humans; D008297:Male; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014808:Vitamin D Deficiency / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D014815:Vitamins / Q000008:administration & dosage* / Q000627:therapeutic use
chemical_list: D015415:Biomarkers; D014815:Vitamins; D002762:Cholecalciferol
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