Skip to main content
Top
Published in: Endocrine 1/2017

01-01-2017 | Endocrine Trials

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

Authors: István Takács, Béla E. Tóth, László Szekeres, Boglárka Szabó, Bence Bakos, Péter Lakatos

Published in: Endocrine | Issue 1/2017

Login to get access

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.
Literature
1.
go back to reference M.F. Holick, T.C. Chen, Vitamin D deficiency: a worldwide problem with health consequences. Am. J. Clin. Nutr. 87, 1080S–1086SS (2008)PubMed M.F. Holick, T.C. Chen, Vitamin D deficiency: a worldwide problem with health consequences. Am. J. Clin. Nutr. 87, 1080S–1086SS (2008)PubMed
2.
go back to reference A.C. Ross, J.E. Manson, S.A. Abrams, J.F. Aloia, P.M. Brannon, S.K. Clinton, R.A. Durazo-Arvizu, J.C. Gallagher, R.L. Gallo, G. Jones, C.S. Kovacs, S.T. Mayne, C.J. Rosen, S.A. Shapses, The 2011 report on dietary reference intakes for calcium and vitamin D from the Institute of Medicine: what clinicians need to know. J. Clin. Endocrinol. Metab. 96, 53–58 (2011)CrossRefPubMed A.C. Ross, J.E. Manson, S.A. Abrams, J.F. Aloia, P.M. Brannon, S.K. Clinton, R.A. Durazo-Arvizu, J.C. Gallagher, R.L. Gallo, G. Jones, C.S. Kovacs, S.T. Mayne, C.J. Rosen, S.A. Shapses, The 2011 report on dietary reference intakes for calcium and vitamin D from the Institute of Medicine: what clinicians need to know. J. Clin. Endocrinol. Metab. 96, 53–58 (2011)CrossRefPubMed
3.
go back to reference I. Takacs, I. Benko, E. Toldy, N. Wikonkál, L. Szekeres, E. Bodolay, E. Kiss, Z. Jambrik, B. Szabó, B. Merkely, Z. Valkusz, T. Kovács, A. Szabó, O. Grigoreff, Z. Nagy, J. Demeter, H.C. Horváth, N. Bittner, S. Várbíró, P. Lakatos, Hungarian consensus about the vitamin D effects on prevention and treatment of diseases. Orv. Hetil. 153(Suppl ), 5–26 (2012)CrossRefPubMed I. Takacs, I. Benko, E. Toldy, N. Wikonkál, L. Szekeres, E. Bodolay, E. Kiss, Z. Jambrik, B. Szabó, B. Merkely, Z. Valkusz, T. Kovács, A. Szabó, O. Grigoreff, Z. Nagy, J. Demeter, H.C. Horváth, N. Bittner, S. Várbíró, P. Lakatos, Hungarian consensus about the vitamin D effects on prevention and treatment of diseases. Orv. Hetil. 153(Suppl ), 5–26 (2012)CrossRefPubMed
4.
go back to reference R. Vieth, P.C. Chan, G.D. MacFarlane, Efficacy and safety of vitamin D3 intake exceeding the lowest observed adverse effect level. Am. J. Clin. Nutr. 73, 288–294 (2001)PubMed R. Vieth, P.C. Chan, G.D. MacFarlane, Efficacy and safety of vitamin D3 intake exceeding the lowest observed adverse effect level. Am. J. Clin. Nutr. 73, 288–294 (2001)PubMed
5.
go back to reference D.E. Lawson, J. Douglas, M. Lean, S. Sedrani, Estimation of vitamin D3 and 25-hydroxyvitamin D3 in muscle and adipose tissue of rats and man. Clin. Chim. Acta. 157, 175–181 (1986)CrossRefPubMed D.E. Lawson, J. Douglas, M. Lean, S. Sedrani, Estimation of vitamin D3 and 25-hydroxyvitamin D3 in muscle and adipose tissue of rats and man. Clin. Chim. Acta. 157, 175–181 (1986)CrossRefPubMed
6.
go back to reference C. Gokce, O. Gokce, C. Baydinc, N. Ilhan, E. Alaşehirli, F. Ozküçük, M. Taşçi, M.K. Atilkeler, H. Celebi, N. Arslan, Use of random urine samples to estimate total urinary calcium and phosphate excretion. Arch. Intern. Med. 151, 1587–1588 (1991)CrossRefPubMed C. Gokce, O. Gokce, C. Baydinc, N. Ilhan, E. Alaşehirli, F. Ozküçük, M. Taşçi, M.K. Atilkeler, H. Celebi, N. Arslan, Use of random urine samples to estimate total urinary calcium and phosphate excretion. Arch. Intern. Med. 151, 1587–1588 (1991)CrossRefPubMed
7.
go back to reference S. Ish-Shalom, E. Segal, T. Salganik, B. Raz, I.L. Bromberg, R.J. Vieth, Comparison of daily, weekly, and monthly vitamin D3 in ethanol dosing protocols for two months in elderly hip fracture patients. Clin. Endocrinol. Metab. 93(9), 3430–3435 (2008)CrossRef S. Ish-Shalom, E. Segal, T. Salganik, B. Raz, I.L. Bromberg, R.J. Vieth, Comparison of daily, weekly, and monthly vitamin D3 in ethanol dosing protocols for two months in elderly hip fracture patients. Clin. Endocrinol. Metab. 93(9), 3430–3435 (2008)CrossRef
8.
go back to reference B. Szabó, Á.G. Tabák, E. Toldy, L. Szekeres, B. Szili, B. Bakos, B. Balla, J.P. Kósa, P. Lakatos, , I. Takács, The role of serum total and free 25-hydroxyvitamin D and PTH values in defining vitamin D status at the end of winter: a representative survey. J. Bone Miner. Metab. (2015) Dec 10. [Epub ahead of print]. B. Szabó, Á.G. Tabák, E. Toldy, L. Szekeres, B. Szili, B. Bakos, B. Balla, J.P. Kósa, P. Lakatos, , I. Takács, The role of serum total and free 25-hydroxyvitamin D and PTH values in defining vitamin D status at the end of winter: a representative survey. J. Bone Miner. Metab. (2015) Dec 10. [Epub ahead of print].
9.
go back to reference V. Chel, H.A. Wijnhoven, J.H. Smit, M. Ooms, P. Lips, Efficacy of different doses and time intervals of oral vitamin D supplementation with or without calcium in elderly nursing home residents. Osteoporos. Int. 19(5), 663–671 (2008)CrossRefPubMed V. Chel, H.A. Wijnhoven, J.H. Smit, M. Ooms, P. Lips, Efficacy of different doses and time intervals of oral vitamin D supplementation with or without calcium in elderly nursing home residents. Osteoporos. Int. 19(5), 663–671 (2008)CrossRefPubMed
10.
go back to reference M.F. Holick, N.C. Binkley, H.A. Bischoff-Ferrari, C.M. Gordon, D.A. Hanley, R.P. Heaney, M.H. Murad, C.M. Weaver, Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline. J. Clin. Endocrinol. Metab 96, 1911–1930 (2011)CrossRefPubMed M.F. Holick, N.C. Binkley, H.A. Bischoff-Ferrari, C.M. Gordon, D.A. Hanley, R.P. Heaney, M.H. Murad, C.M. Weaver, Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline. J. Clin. Endocrinol. Metab 96, 1911–1930 (2011)CrossRefPubMed
11.
go back to reference A. Sorva, J. Risteli, L. Risteli, M. Valimaki, R. Tilvis, Effects of vitamin D and calcium on markers of bone metabolism in geriatric subjects with low serum 25-hydroxyvitamin D levels. Calcif. Tissue Int 49(Suppl, ), S88–S89 (1991)CrossRefPubMed A. Sorva, J. Risteli, L. Risteli, M. Valimaki, R. Tilvis, Effects of vitamin D and calcium on markers of bone metabolism in geriatric subjects with low serum 25-hydroxyvitamin D levels. Calcif. Tissue Int 49(Suppl, ), S88–S89 (1991)CrossRefPubMed
12.
go back to reference R.P. Heaney, K.M. Davies, T.C. Chen, M.F. Holick, M.J. Barger-Lux, Human serum 25-hydroxycholecalciferol response to extended oral dosing with cholecalciferol. Am. J. Clin. Nutr. 77, 204–210 (2003)PubMed R.P. Heaney, K.M. Davies, T.C. Chen, M.F. Holick, M.J. Barger-Lux, Human serum 25-hydroxycholecalciferol response to extended oral dosing with cholecalciferol. Am. J. Clin. Nutr. 77, 204–210 (2003)PubMed
13.
go back to reference A.M. Kenny, B. Biskup, B. Robbins, G. Marcella, J.A. Burleson, Effects of vitamin D supplementation on strength, physical function, and health perception in older, community-dwelling men. J. Am. Geriatr. Soc. 51, 1762–1767 (2003)CrossRefPubMed A.M. Kenny, B. Biskup, B. Robbins, G. Marcella, J.A. Burleson, Effects of vitamin D supplementation on strength, physical function, and health perception in older, community-dwelling men. J. Am. Geriatr. Soc. 51, 1762–1767 (2003)CrossRefPubMed
14.
go back to reference E.S. Orwoll, R.M. Weigel, S.K. Oviatt, M.R. McClung, L.J. Deftos, Calcium and cholecalciferol: effects of small supplements in normal men. Am. J. Clin. Nutr. 48, 127–130 (1988)PubMed E.S. Orwoll, R.M. Weigel, S.K. Oviatt, M.R. McClung, L.J. Deftos, Calcium and cholecalciferol: effects of small supplements in normal men. Am. J. Clin. Nutr. 48, 127–130 (1988)PubMed
15.
go back to reference J. Pepe, I. Mezzaroma, A. Fantauzzi, M. Falciano, A. Salotti, M. Di Traglia, D. Diacinti, P. Biondi, C. Cipriani, M. Cilli, S. Minisola, An oral high dose of cholecalciferol restores vitamin D status in deficient postmenopausal HIV-1-infected women independently of protease inhibitors therapy: a pilot study. Endocrine 53, 299–304 (2016)CrossRefPubMed J. Pepe, I. Mezzaroma, A. Fantauzzi, M. Falciano, A. Salotti, M. Di Traglia, D. Diacinti, P. Biondi, C. Cipriani, M. Cilli, S. Minisola, An oral high dose of cholecalciferol restores vitamin D status in deficient postmenopausal HIV-1-infected women independently of protease inhibitors therapy: a pilot study. Endocrine 53, 299–304 (2016)CrossRefPubMed
16.
go back to reference K.M. Sanders, A.L. Stuart, E.J. Williamson, J.A. Simpson, M.A. Kotowicz, D. Young, G.C. Nicholson, Annual high-dose oral vitamin D and falls and fractures in older women: a randomized controlled trial. JAMA. 303, 1815–1822 (2010)CrossRefPubMed K.M. Sanders, A.L. Stuart, E.J. Williamson, J.A. Simpson, M.A. Kotowicz, D. Young, G.C. Nicholson, Annual high-dose oral vitamin D and falls and fractures in older women: a randomized controlled trial. JAMA. 303, 1815–1822 (2010)CrossRefPubMed
17.
go back to reference M. Rossini, S. Adami, O. Viapiana, E. Fracassi, L. Idolazzi, M.R. Povino, D. Gatti, Dose-Dependent short-term effects of single high doses of oral vitamin D3 on bone turnover markers. Calcif. Tissue Int. 91, 365–369 (2012)CrossRefPubMed M. Rossini, S. Adami, O. Viapiana, E. Fracassi, L. Idolazzi, M.R. Povino, D. Gatti, Dose-Dependent short-term effects of single high doses of oral vitamin D3 on bone turnover markers. Calcif. Tissue Int. 91, 365–369 (2012)CrossRefPubMed
18.
go back to reference E.B. Mawer, K. Schaefer, G.A. Lumb, S.W. Stanbury, The metabolism of isotopically labelled vitamin D3 in man: the influence of the state of vitamin D nutrition. Clin Sci. 40, 39–53 (1971)CrossRefPubMed E.B. Mawer, K. Schaefer, G.A. Lumb, S.W. Stanbury, The metabolism of isotopically labelled vitamin D3 in man: the influence of the state of vitamin D nutrition. Clin Sci. 40, 39–53 (1971)CrossRefPubMed
19.
go back to reference A. Shieh, R.F. Chun, C. Ma, S. Witzel, B. Meyer, B. Rafison, L. Swinkels, T. Huijis, S. Pepkowitz, B. Holmquist, M. Hewison, J.S. Adams, Effects of high-dose vitamin D2 versus D3 on total and free 25-Hydroxyvitamin D and markers of calcium balance. J. Clin. Endocrinol. Metab. 101, 3070–3078 (2016)CrossRefPubMed A. Shieh, R.F. Chun, C. Ma, S. Witzel, B. Meyer, B. Rafison, L. Swinkels, T. Huijis, S. Pepkowitz, B. Holmquist, M. Hewison, J.S. Adams, Effects of high-dose vitamin D2 versus D3 on total and free 25-Hydroxyvitamin D and markers of calcium balance. J. Clin. Endocrinol. Metab. 101, 3070–3078 (2016)CrossRefPubMed
Metadata
Title
Randomized clinical trial to comparing efficacy of daily, weekly and monthly administration of vitamin D3
Authors
István Takács
Béla E. Tóth
László Szekeres
Boglárka Szabó
Bence Bakos
Péter Lakatos
Publication date
01-01-2017
Publisher
Springer US
Published in
Endocrine / Issue 1/2017
Print ISSN: 1355-008X
Electronic ISSN: 1559-0100
DOI
https://doi.org/10.1007/s12020-016-1137-9

Other articles of this Issue 1/2017

Endocrine 1/2017 Go to the issue

Clinical Management of Endocrine Diseases

SIADH: differential diagnosis and clinical management

Live Webinar | 27-06-2024 | 18:00 (CEST)

Keynote webinar | Spotlight on medication adherence

Live: Thursday 27th June 2024, 18:00-19:30 (CEST)

WHO estimates that half of all patients worldwide are non-adherent to their prescribed medication. The consequences of poor adherence can be catastrophic, on both the individual and population level.

Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.

Prof. Kevin Dolgin
Prof. Florian Limbourg
Prof. Anoop Chauhan
Developed by: Springer Medicine
Obesity Clinical Trial Summary

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.

Developed by: Springer Medicine