Találati lista | Tudóstér

001-es BibID:	BIBFORM113301
035-os BibID:	(WOS)001009706200001 (Scopus)85159819117 (cikkazonosító)106330
Első szerző:	Takács István
Cím:	Controlled randomized open label clinical study comparing the safety and efficacy of loading schedules in vitamin D deficient patients / Istvan Takacs, Bence Bakos, Zsuzsanna Nemeth, Bela E. Toth, Balazs Szili, Peter Lakatos
Dátum:	2023
ISSN:	0960-0760
Megjegyzések:	Rapidly restoring vitamin D levels to normal might be desirable in certain clinical situations. Larger doses of supplementation, have been shown to increase bone loss and the risk of falls. The optimal way to perform vitamin D loading safely and effectively is still not well elucidated. Our study was aimed to assess the safety andefficacy of two oral vitamin D loading protocols. Sixty-nine subjects with vitamin D deficiency (25OH-vitamin D (25(OH)D) < 20 ng/ml) were included. Thirty-five participants received 30 000 IU of vitamin D3 per week for 10 weeks (group Slower Loading Dose (SLD)) and thirty-four received 30 000 IU twice weekly for 5 weeks (group Moderate Loading Dose (MLD)) resulting in a loading dose of 300 000 IU for all subjects. Following this initial loading phase, both groups received 30 000 IU biweekly for 4 weeks to test whether the recommended daily vitamin D supplementation in range of 2000 IU dose-equivalent could maintain the achieved levels. Seventy-nine percent of those subjects treated in group SLD and everyone in group MLD achieved a 25(OH)D level of 30 ng/ ml, which is the lower limit of the recommended normal range in Hungary. The mean increase in 25(OH)D was significantly higher in group MLD than in group SLD (38.6 ? 1.80 ng/ml vs 46,6 ? 1.80 ng/ml). No significant decrease was observed with the administration of the maintenance dose. There were no clinically significant changes in serum or urine calcium, and bone biomarkers in either group. Both protocols were found to be safe and effective, but the five-week dosing caused a significantly greater increase in 25(OH)D. A maintenance dose applied for four weeks after the loading protocol did not raise 25(OH)D levels further but maintained the ach- ieved increase. The administration of 30 000 IU of vitamin D3 twice weekly for five weeks is a rapid, effective and safe way to treat vitamin D deficiency in vitamin D deficient patients.
Tárgyszavak:	Orvostudományok Gyógyszerészeti tudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk
Megjelenés:	Journal Of Steroid Biochemistry And Molecular Biology. - 231 (2023), p. 1-7. -
További szerzők:	Bakos Bence Németh Zsuzsanna Tóth E. Béla (1960-) (orvos) Szili Balázs Lakatos Péter (Semmelweis Egyetem)
Internet cím:	Szerző által megadott URL DOI Intézményi repozitóriumban (DEA) tárolt változat
Borító:
Saját polcon:

001-es BibID:	BIBFORM073659
Első szerző:	Takács István
Cím:	Randomized clinical trial to comparing efficacy of daily, weekly and monthly administration of vitamin D3 / István Takács, Béla E. Tóth, László Szekeres, Boglárka Szabó, Bence Bakos, Péter Lakatos
Dátum:	2016
ISSN:	1355-008X 1559-0100
Megjegyzések:	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.
Tárgyszavak:	Orvostudományok Gyógyszerészeti tudományok idegen nyelvű folyóiratközlemény külföldi lapban
Megjelenés:	Endocrine 55 : 1 (2016), p. 60-65. -
További szerzők:	Tóth E. Béla (1960-) (orvos) Szekeres László Szabó Boglárka Bakos Bence Lakatos Péter (belgyógyász)
Internet cím:	Szerző által megadott URL DOI Intézményi repozitóriumban (DEA) tárolt változat
Borító:
Saját polcon:

001-es BibID:	BIBFORM073660
Első szerző:	Tóth E. Béla (orvos)
Cím:	Safety and Efficacy of Weekly 30,000 IU Vitamin D Supplementation as a Slower Loading Dose Administration Compared to a Daily Maintenance Schedule in Deficient Patients : a Randomized, Controlled Clinical Trial / Bela E. Toth, Istvan Takacs, Laszlo Szekeres, Boglarka Szabo, Bence Bakos, Peter Lakatos
Dátum:	2017
ISSN:	2329-6887
Megjegyzések:	Introduction: The primary objective of the study was to assess the safety and the efficacy of a "Slower Loading"dose of 30,000 IU vitamin D3 supplementation administered in a weekly schedule for 12 weeks in vitamin D deficientpatients compared to the daily equivalent dose of 1000 IU/day regimens in a clinical trial.Methods: This open label, randomized, controlled, multicenter clinical trial was performed during the spring andsummer period enrolling adult subjects with 25OHD levels <20 ng/ml. In a sub-study presented here, subjects wererandomized into two treatment groups using 30,0000 IU Vitamin D3 film coated tablets either in weekly (WD30Kgroup, daily dose equivalent of 4286 IU/day) or a standard dose for maintenance treatment in a daily administration(SDD1K group, 1000 IU/day). Subjects in a control group received a similar 30,0000 IU Vitamin D3 film coatedtablets in a once-per-month schedule (MD30K), dosing schedule for 12 weeks, (an equivalent to 1000 IU/day). Theassessment of efficacy made by the changes in 25OHD and PTH levels in a throughout 12 weeks. Routinelaboratory tests, serum and urinary calcium served for laboratory-safety assessments in every 4 weeks throughoutthe duration of the study.Results: The baseline values of 25OHD at in group (WD30K, SDD1K and MD30K) were in similar range: 13.7 ?3.7 ng/mL, 13.48 ? 3.9 ng/mL and 13.1 ? 4.3 ng/mL, respectively. A daily dose of 1000 IU for 12 weeks was effectivein restoration of 25OHD values to above 20 ng/mL (50 nmol/L), however the median of the group failed to attain the30 ng/mL (75 nmol/L) threshold. Dose-response was statistically different in the 4286 IU/day group compared to a1000 IU/daily dose (p<0.001) for all study visits. Treatment efficiency assessed on two levels and for treatmentduration of 8 and 12 weeks. The limit of 25 ng/mL was achieved by 95% of patients in 8 weeks with 30,000 IU/wkadministration (vs. only 33% with 1000 IU/d) but more prominent difference observed with the limit of desired range(>30 ng/ml): 91% vs. 10% of subjects in after 8 weeks with 30,000 IU/wk and 1000 IU/d doses and 95% vs. 24% byend of the 12 weeks of treatment. The treatment-related increment potential was in a range of 2.26-2.92 ng/week forthe weekly 30K dosing group compared to 1.32-1.70 ng/week for the 1000 IU/day standard maintenance dose groupafter 8 weeks. Treatment with 30,000 IU doses of Vitamin D3 in a weekly administration for 12 weeks did not abolishserum calcium levels. No difference in frequency of laboratory adverse events and other safety parameters wasobserved compared to lower maintenance doses or to control group.Conclusion: The safety of weekly loading oral doses of 30,000 IU vitamin D3 tablets was demonstrated andefficacy compared to the maintenance treatment with a daily dose equivalent of 1000 IU/d, in a daily or in monthlyschedule in vitamin D deficient, adult population. Weekly administration of 30,000 IU loading dose for 12 weeks doesnot raise safety concern, but provides an effective tool for normalization of 25OHD levels to the desirable level of>30ng/mL in deficient patients
Tárgyszavak:	Orvostudományok Gyógyszerészeti tudományok idegen nyelvű folyóiratközlemény külföldi lapban
Megjelenés:	Journal of Pharmacovigilance. - 5 : 4 (2017), p. 1-10. -
További szerzők:	Takács István Szekeres László Szabó Boglárka Bakos Bence Lakatos Péter
Internet cím:	Szerző által megadott URL DOI Intézményi repozitóriumban (DEA) tárolt változat
Borító:
Saját polcon: