E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10047626 |
E.1.2 | Term | Vitamin D deficiency |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of the study is to evaluate the efficacy of MEGA compared to Kalcipos on S-25-OH-D after 12 months treatment in Subjects aged 55-85 years with a S-25-OH-D level within 10 and 70 nmol/L at the time of screening. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of the study are to evaluate the efficacy of MEGA compared to Kalcipos on S-25-OH-D, S-PTH intact, S-25-OH-D in correlation to S-PTH intact and physical functions, assessed as TUG and incidence of falls, during and after 12 months treatment, assessed at 0 (baseline), 3, 6, 9 and 12 months, and S-BALP, S-TRACP5B assessed at 0, 6, 12 months and to evaluate the safety of MEGA compared to Kalcipos assessed in Serious Adverse Events and Adverse Events (laboratory safety variables, vital sign and symptoms) during and after 12 months treatment. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
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. |
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E.4 | Principal exclusion criteria |
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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
S-25-OH-D after 12 months treatment. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |