Computational protocol: Cholecalciferol Additively Reduces Serum Parathyroid Hormone Levels in Severe Secondary Hyperparathyroidism Treated with Calcitriol and Cinacalcet among Hemodialysis Patients

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Protocol publication

[…] The trial was designed as a randomized, controlled open-label study. A total of 80 patients were eligible and agreed to participate. Group matching with gender, age (within 5 years), and duration of hemodialysis (within 1 year) was conducted for every pair group and they were then randomly assigned to either treatment with cinacalcet, calcitriol and cholecalciferol (CCC, study group) or control group, treated with cinacalcet, calcitriol and placebo (CCP, control group). G*power was used to calculate the required sample size [] and effects were detected in a two-sided test with a power of (1 − β) = 80% at a significance level of 0.05. Other calculation settings were as follows: (1) the randomization process was based on 1:1 proportion of this study; (2) the effect size was set as 0.8. The required sample size for calculating was at least 25 subjects in the CCC group and 25 subjects in the CCP group. [...] The results were expressed as mean ± standard deviation or median (interquartile range). Parametric or non-parametric tests were used for analysis; for paired data, the Student t or Wilcoxon tests, respectively, and for between-group comparisons, the Student t, one-way ANOVA or Mann–Whitney U tests were used. Unilateral correlation analysis was performed using Pearson (r) or Spearman correlation (rs), as appropriate. All the tests were two-sided, and p < 0.05 was considered statistically significant. Statistica (Version 11, Stat Soft, Inc., 2300 East 14th Street, Tulsa, OK 74104, USA) was used for calculations. […]

Pipeline specifications

Software tools G*Power, Statistica
Application Miscellaneous
Organisms Homo sapiens
Diseases Bone Diseases, Hyperparathyroidism, Secondary
Chemicals Calcitriol, Cholecalciferol, Vitamin D