A phase IV, two-armed, randomized, cross-over study comparing compliance with once-a-month administration of vitamin D3 to compliance with daily administration of a fixed-dose combination of vitamin D3 and calcium during two 6-month periods
25OHD; compliance; preference; randomized controlled trial; vitamin D
Abstract :
[en] Summary In a randomized, cross-over study, once monthly
administration of vitamin D3 was preferred over a once daily
administration of a fixed-dose combination of vitamin D3 and
calcium, with a better compliance but without any significant
difference in the increase in vitamin D levels.
Introduction The aim of the present study was to compare a
once-monthly administration of vitamin D3 to a daily administration
of a fixed-dose combination of vitamin D3 and calcium
during two treatment periods of 6 months.
Methods One hundred volunteers aged 50 years old or older
were randomized to receive either one drinkable ampoule containing
25,000 IU vitamin D3 (D-Cure®, SMB) once monthly
(group VD) or one chewable tablet containing 1000 mg calcium
carbonate+800 IU vitamin D3 (Steovit Forte®, Takeda)
once daily (group VDCa) during 6 months. After the first
6 months of treatment, the groups were reversed according
to the randomized cross-over design. Treatment compliance
(i.e. the primary outcome), preference, acceptability and vitamin
D levels and adverse events were all collected.
Results For the two periods, the patients had a significantly
higher compliance in the VD group than in the VDCa group
(p<0.0001). During the study, 50 (56.8 %) patients preferred
the VD treatment, 16 (18.2 %) patients preferred the VDCa,
and for 22 (25.0 %) patients, neither treatment was preferred.
At the end of the first 6 months of treatment, the mean (SD)
increase of 25(OH)D was 6.57 ng/mL (8.19) in the VD group
and 3.88 ng/mL (10.0) in the VDCa group (p=0.16 between
groups).
Conclusion In this study, a once-monthly administration of
vitamin D3 was preferred over a once-daily administration
of a fixed-dose combination of vitamin D3 and calcium, with
a better compliance but without any significant difference in
the increase in vitamin D levels.
Disciplines :
General & internal medicine
Author, co-author :
Bruyère, Olivier ; Université de Liège > Département des sciences de la santé publique > Santé publique, Epidémiologie et Economie de la santé
DEROISY, Rita ; Centre Hospitalier Universitaire de Liège - CHU > Médecine de l'appareil locomoteur
Dardenne, Nadia ; Université de Liège > Département des sciences de la santé publique > Santé publique, Epidémiologie et Economie de la santé
Cavalier, Etienne ; Université de Liège > Département de pharmacie > Chimie médicale
COFFINER, M
da silva, S
De Niet, S.
Reginster, Jean-Yves ; Université de Liège > Département des sciences de la santé publique > Santé publique, Epidémiologie et Economie de la santé
Language :
English
Title :
A phase IV, two-armed, randomized, cross-over study comparing compliance with once-a-month administration of vitamin D3 to compliance with daily administration of a fixed-dose combination of vitamin D3 and calcium during two 6-month periods
Publication date :
December 2015
Journal title :
Osteoporosis International
ISSN :
0937-941X
eISSN :
1433-2965
Publisher :
Springer Science & Business Media B.V., Godalming, United Kingdom
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