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Vitamin D – monthly dosing was better than daily with Calcium – RCT Dec 2015

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.

Osteoporos Int. 2015 Dec;26(12):2863-8. doi: 10.1007/s00198-015-3205-z. Epub 2015 Jun 23.
Bruyère O1, Deroisy R2, Dardenne N3, Cavalier E4, Coffiner M5, Da Silva S5, De Niet S5, Reginster JY3.
1Support Unit in Epidemiology and Biostatistics, Department of Public Health, Epidemiology and Health Economics, University of Liège, Liège, 4000, Belgium. olivier.bruyere at ulg.ac.be.
2Médecine Appareil Locomoteur, CHU Liège, BRULL, Liège, Belgium.
3Support Unit in Epidemiology and Biostatistics, Department of Public Health, Epidemiology and Health Economics, University of Liège, Liège, 4000, Belgium.
4Department of Clinical Chemistry, University of Liège, Liège, Belgium.
5SMB Belgium, Brussels, Belgium.

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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.

PMID: 26100413 PMCID: PMC4656705 DOI: 10.1007/s00198-015-3205-z

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7087 Monthly daily.pdf PDF 2016 admin 17 Sep, 2016 15:35 258.74 Kb 188
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