title: Preference for and acceptability of twoformulations of a dietary supplement containing calcium plus vitamin D3: A randomized, open-label, crossover trial in adult patients with calcium and vitamin D deficiencies.
abstract: BACKGROUND
  Preference for and acceptability of a drug are crucial for complianceand hence optimal treatment of diseases that require long-term management (eg, osteoporosis). The preference for and acceptability of a chewable tablet containing calcium and vitamin D3 and a dose-comparable effervescent powder were assessed in a Phase 4, randomized, open-label, crossover trial in 5 European countries (Sweden, Finland, Belgium, the Netherlands, and Greece).
  
  
  OBJECTIVE
  The aim of the present analysis was to compare the preference for and acceptability, including tolerability, of these 2 formulations based on the Belgian results of the previously mentioned study.
  
  
  METHODS
  Patients were recruited from 3 osteoporosis units and universityhospitals in Brussels, Liege, and Ghent, Belgium. Adult patients at risk for calcium and vitamin D deficiencies were enrolled. The study drugs included 2 formulations of a dietary supplement containing a combination of calcium plus vitamin D3: chewable tablets (calcium carbonate, 1250 mg; vitamin D3, 400 IU) (A) and effervescent powder (calcium carbonate, 1250 mg; vitamin D3, 440 IU) (B). Patients were randomly assigned to receive 1 of 2 treatment sequences: AB or BA. Both formulations were given PO BID for 14 days, with a switch to the alternate formulation occurring on day 15 of the study. Preference and acceptability were assessed using 2 questionnaires: one assessed 5 variables of acceptability using 11-point scales, and the other assessed preference using yes/no questions. Compliance and tolerability were recorded throughout the study, with unused dose counts and recording of adverse events (AEs), respectively.
  
  
  RESULTS
  The study comprised 200 patients, 199 of whom received at least 1 dose of study medication and were included in the intent-to-treat analysis (174 women, 25 men; mean age, 66 years [range, 30-87 years]). Preference data were available in 178 patients, 129 of whom (72.5%) preferred the chewable tablet compared with 34 (19.1%) who preferred the effervescent powder and 15 (8.4%) who had no preference (both, P < 0.001 vs tablet). The preference for the tablet was based on consistently and significantly higher mean scores on all 5 variables of acceptability (all, P < 0.001). The most common AEs were gastrointestinal (tablet, 27/192 patients [14.1%]; powder, 31/190 patients [16.3%]). Eighteen patients (9.0%) discontinued the trial due to ≥1 AE (12 receiving the tablet and 6 receiving the powder).
  
  
  CONCLUSIONS
  In this study of preference for and acceptability of 2 formulations (chewable tablet and effervescent powder) of a dietary supplement containing a combination of calcium plus vitamin D3 in Belgian adults at risk for calcium and vitamin D deficiencies, the chewable tablet was preferred by a significant majority. Based on 5 variables, the tablet was found to be significantly more acceptable than the powder. Tolerability was similar between the 2 formulations.
authors.affiliation: Bone and Cartilage Metabolism Research Unit, University of Liege, Liege, Belgium.
authors.forename: Jean Yves
authors.initials: JY
authors.lastname: Reginster
authors.affiliation: Department of Endocrinology, University Hospital, Ghent, Belgium.
authors.forename: J M
authors.initials: JM
authors.lastname: Kaufman
authors.affiliation: Rheumatology Service, Ersame Hospital, Brussels, Belgium.
authors.forename: V
authors.initials: V
authors.lastname: Gangjii
keywords: acceptance; calcium; elderly; formulation; osteoporosis; preference; vitamin D3