A randomized, double-blind, parallel-group study evaluating efficacy and safety of MEGA tablets compared to Kalcipos® tablets in adult Subjects

Recip AB0 个研究点开始时间: 2006年9月28日最近更新: 2012年3月19日

适应症

试验速览

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•Male and female Subject 55-85 years of age.Subject with a S-25-OH-D level within 10 and 70 nmol/L at the time of screening.Signed Informed Consent obtained prior to inclusion into the study.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Subject suffering from serious disease, at the discretion of the Investigator.Subject with suspected osteomalacia, at the discretion of the Investigator.Subject with known or suspected hypersensitivity to any of the IMPs, see SPCs (e.g. hypersensitivity to peanuts or soy). Subject suffering from conditions in which calcium and/or D-vitamin are contraindicated.Subject on regular vitamin D supplementation during the last three months. Subject requiring medicinal treatment interacting with any of the IMPs or influencing study results such as thiazide, phenytoin, carbamazepine, bisphosphonates, cardiac glycosides and/or additional calcium treatment.Subject suffering from urolithiasis.Subject suffering from renal insufficiency defined as P-Creatinine >130 µmol/L at the time of screening.Subject suffering from liver disease defined as >2 x upper reference limit of P-ALAT and/or P-GT at the time of screening or reported in the medical chart.Subject with a P-ALP more than 50% above upper reference limit at the time of screening.Subject with a S-Calcium (ionised) >1.34 nmol/L and/or total S-Calcium >2.6 nmol/L at the time of screening.Subject with a P-Albumin <32 g/L at the time of screening.Subject with extensive outdoor activities (i.e. sun-exposure), at the discretion of the Investigator.Subject suspected to be unable to comply with the study at the discretion of the Investigator.Subject treated in a Clinical Trial (i.e. with another IMP) within one month prior to this trial.

发起方

Recip AB