PMID- 24672109
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20140327
LR  - 20211021
IS  - 0011-393X (Print)
IS  - 0011-393X (Linking)
VI  - 66
IP  - 1
DP  - 2005 Jan
TI  - 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.
PG  - 23-34
LID - 10.1016/j.curtheres.2005.03.003 [doi]
AB  - 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.
FAU - Reginster, Jean Yves
AU  - Reginster JY
AD  - Bone and Cartilage Metabolism Research Unit, University of Liege, Liege, Belgium.
FAU - Kaufman, J M
AU  - Kaufman JM
AD  - Department of Endocrinology, University Hospital, Ghent, Belgium.
FAU - Gangjii, V
AU  - Gangjii V
AD  - Rheumatology Service, Ersame Hospital, Brussels, Belgium.
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Curr Ther Res Clin Exp
JT  - Current therapeutic research, clinical and experimental
JID - 0372621
PMC - PMC3964541
OTO - NOTNLM
OT  - acceptance
OT  - calcium
OT  - elderly
OT  - formulation
OT  - osteoporosis
OT  - preference
OT  - vitamin D3
EDAT- 2005/01/01 00:00
MHDA- 2005/01/01 00:01
PMCR- 2005/01/01
CRDT- 2014/03/28 06:00
PHST- 2004/11/09 00:00 [accepted]
PHST- 2014/03/28 06:00 [entrez]
PHST- 2005/01/01 00:00 [pubmed]
PHST- 2005/01/01 00:01 [medline]
PHST- 2005/01/01 00:00 [pmc-release]
AID - S0011-393X(05)00019-6 [pii]
AID - 10.1016/j.curtheres.2005.03.003 [doi]
PST - ppublish
SO  - Curr Ther Res Clin Exp. 2005 Jan;66(1):23-34. doi: 
      10.1016/j.curtheres.2005.03.003.