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Randomized clinical trial to comparing efficacy of daily, weekly and monthly administration of vitamin D3

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Abstract

The comparative efficacy and safety profiles of selected daily 1000 IU, weekly 7000 IU and monthly 30,000 IU vitamin D 3—not previously investigated—will be evaluated. Here, a prospective, randomized clinical trial, comparing efficacy and safety of a daily single dose of 1000 IU (group A) to a once-weekly 7000 IU dose (group B), or monthly 30,000 IU dose (group C) of vitamin D3. The present study is a controlled, randomized, open-label, multicenter clinical trial, 3  months in duration. Sixty-four adult subjects with vitamin D deficiency (25OHD<20 ng/ml), were included according to the inclusion and exclusion criteria. Dose-responses for increases in serum vitamin 25OHD were statistically equivalent for each of the three groups: A, B and C. Outcomes were 13.0 ± 1.5; 12.6 ± 1.1 and 12.9 ± 0.9 ng/ml increases in serum 25OHD per 1000 IU, daily, weekly and monthly, respectively. The treatment of subjects with selected doses restored 25OHD values to levels above 20 ng/ml in all groups. Treatment with distinct administration frequency of vitamin D3 did not exhibit any differences in safety parameters. The daily, weekly and monthly administrations of daily equivalent of 1000 IU of vitamin D3 provide equal efficacy and safety profiles.

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Acknowledgments

The authors are sincerely grateful to Stephanie C. Fox, J.D. of QueenBeeEdit of Bloomfield Connecticut, U.S.A. for her technical assistance in language improvement and proofreading of the manuscript. This work was supported by Pharma Patent KFT. There are no other organizations with any financial interest in the subject matter or material discussed in the manuscript.

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Authors and Affiliations

  1. 1st Department of Internal Medicine, Semmelweis University Faculty of Medicine, Koranyi Sándor u. str 2/a, Budapest, 1083, Hungary

    István Takács, Boglárka Szabó, Bence Bakos & Péter Lakatos

  2. Department of Pharmaceutical Surveillance and Economy, University of Debrecen Faculty of Pharmacy, Nagyerdei krt 98, Debrecen, 4032, Hungary

    Béla E. Tóth

  3. National Institute of Rheumatology and Physiotherapy, Frankel Leo str. 25-29, Budapest, 1023, Hungary

    László Szekeres

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  1. István Takács
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Correspondence to István Takács.

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Conflict of interest

Béla E Tóth consulted for Pharma Patent KFT. Péter Lakatos and István Takács received lecture fees from Pharma Patent KFT. László Szekeres, Boglárka Szabó and Bence Bakos declare that they have no conflict of interest.

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Takács, I., Tóth, B.E., Szekeres, L. et al. Randomized clinical trial to comparing efficacy of daily, weekly and monthly administration of vitamin D3 . Endocrine 55, 60–65 (2017). https://doi.org/10.1007/s12020-016-1137-9

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  • DOI: https://doi.org/10.1007/s12020-016-1137-9

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