Study subjects and study design
CKD
RENAL DISEASE, SECONDARY HYPERPARATHYROIDISM
This was originally a double-blind, randomized, PBO controlled study (EudraCT 2011–002,586-38, date of registration: 2011–08-24) with the primary aim of assessing the efficacy of a high daily dose of cholecalciferol on the development of secondary hyperparathyroidism. The results from this study have been published previously [In brief, patients with CKD G3—G4 and secondary hyperparathyroidism were recruited and randomized to either treatment with cholecalciferol, 8,000 IU per day (Vitamin D3 Forte Renapharma) for 12 weeks, or to PBO.Patients were eligible for enrollment in the original study if they had a serum level of parathyroid hormone (PTH) above 6.8 pmol/L, 25(OH)D below 75 nmol/L, an estimated glomerular filtration rate (eGFR) quantified with the Modification of Diet in Renal Disease formula between the level of 15 and 59 mL/min/1.73 mThe study was compliant with the Declaration of Helsinki. The Ethical Review board in Uppsala (Ref 2011/313) as well as the Swedish Medical Products Agency approved the study protocol.