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academies
September 15-16, 2017 | Dallas, USA
International Conference on
VITAMINS, NUTRIGENOMICS & MALNUTRITION
Insights Nutr Metab 2017
Volume 1 Issue 1
T
he main objective of the present study was to demonstrate efficacy
and safety of three different vitamin D
3
treatment protocols with the
same cumulative dose in vitamin D-deficient subjects. Adult subjects
with vitamin D deficiency (25OHD<20 ng/ml), were included according to
the inclusion and exclusion criteria. A daily single dose of 1000 IU (group
DD1K) to a once weekly dose 7000 IU (group WD7K), or monthly dose of
30,000 IU (group MD30K) of vitamin D
3
were administered for 12-weeks.
The comparative efficacy and safety profiles of these selected maintenance
doses of vitamin D
3
has been evaluated in a prospective, randomized clinical
trial. Additional to safety parameters, the measurements of 25OHD and PTH
were completed in every 4 weeks. The treatment efficacy was compared
between groups by inclusion levels (i.e. <10 ng/ml and 10-20 ng/ml initial
plasm 25OHD values at screening). The dose-response were similar in these
three groups, 13.0±1.5; 12.6±1.1 and 12.9±0.9 ng/ml. Thus the treatment
of vitamin D-deficient subjects with different treatment regimens of 1000
IU/daily dose were judged to be equally effective in restoration of 25OHD
values to above 20 ng/ml. The increase of 25OHD in the group with “low”
(<10 ng/ml) initial values was significantly higher (14.05-20.9 ng/ml) by the
end of the treatment period in treatment group than that in the group with
“moderately-insufficient” (10-20 ng/ml) baseline values (11.54-14.9 ng/ml).
The calculated efficacy relative to the baseline resulted in Effnd=1.72-2.66
of subjects with the “low” and Effnd=0.75-0.92 in moderately deficient
subjects. Outcomes of the present RCT investigation demonstrated similar
efficacy and safety profile of daily, weekly and monthly dosing equivalent
of 1000 IU/day vitamin D
3
. The present study utilized vitamin D
3
tablets
commercially available for the public with selected dosing schedules to
achieve the best adherence to treatment goals.
Speaker Biography
Bela E Toth MD, PhD, MBA, has her academic background based on neuroendocrine
and cell biology research (Semmelweis University, Neuroendocrine research group
at Academy of Sciences Hungary; Rudolph Magnus Institute of Pharmacology,
Utrecht: The Netherlands; Dept. of Molecular and Cell Biology: Penn State University,
USA). She was academically appointments as a university Lecturer (Medical School)
and Invited lecturer for graduate and postgraduate education and recently as an
Associate Professor, Head of Department of Pharmaceutical Surveillance and Economy
at Debrecen University, teaching pharmacovigilance, pharmaceutical business-
management, and drug development. Her clinical research experience is based on
clinical operation management and clinical quality site management including senior
level consultancy for pharmaceutical industry (research /project management, drug
development, medical affairs) and clinical operational head. The research projects
covered the range of development phases (I/II to III-IV) including specific areas such as
bioequivalence and post-marketing safety trials as well.
e:
tothe.bela@pharm.unideb.huRandomized clinical trial comparing the efficacy of daily, weekly and monthly administration of
vitamin D
3
Bela E Toth
1
, Istvan Takacs
2
, Boglarka Szabo
2
, Bence Bakos
2
, Laszlo Szekeres
3
and
Peter Lakatos
2
1
University of Debrecen, Hungary
2
Semmelweis University School of Medicine, Hungary
3
National Institute of Rheumatology and Physiotherapy, Hungary