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

• Conditions: Vitamin D deficiency; MedDRA version: 8.1Level: LLTClassification code 10047626Term: Vitamin D deficiency

• Registration Number: EUCTR2006-002595-17-SE
• Lead Sponsor: Recip AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified