Vitamin D deficiency MedDRA version: 8.1 Level: LLT Classification code 10047626 Term: Vitamin D deficiency
Conditions
Interventions
Product Code: MEGA film-coated tablet
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Cholecalciferol
CAS Number: 67-97-0
Concentration unit: µg microgram(s)
Concentration type: equal
Con
Sponsors
Recip AB
Eligibility
Sex/Gender
All
Inclusion criteria
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. 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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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.;Primary end point(s): S-25-OH-D after 12 months treatment. | — |
Countries
Sweden
Outcome results
None listed