Normal distribution was evaluated with visual inspection of histograms with normal curve, and determination of skewness and kurtosis. All dependent variables except serum OPG and RANKL were considered normally distributed at baseline. After log transformation OPG attained normal distribution and was used as such when parametric statistics were applied. Because of several 0-values (not detectable) RANKL could not be log transformed and therefore was evaluated with non-parametric statistics. The delta values for OPG and RANKL were also not normally distributed and could not be log transformed because of several 0-values, and were therefore evaluated with non-parametric statistics. The other delta values were normally distributed. A multiple linear regression model with age, gender, BMI, smoking status, serum 25(OH)D, serum PTH and serum calcium as covariates was used to evaluate individual predictor of BMD L2-L4, BMD total hip and serum OPG. Correlations were evaluated with Pearson's or Spearman's correlation coefficients as appropriate.
The intervention study was analysed per protocol. Comparisons between the groups at baseline and between their delta values (value at end of the study minus value at baseline) were performed with ANOVA, the Kruskall Wallis test or the Chi-square test. The Bonferroni correction was used where multiple comparisons were performed. Unless otherwise stated, data are expressed as mean ± SD. All tests were done two-sided, and P-value < 0.05 was considered statistically significant. The Statistical Package for Social Sciences version 15.0 was used for all statistical analyses (SPSS Inc., Chicago, Ill., USA).
The power calculation was performed according to the primary end point (weight loss) to disclose a clinically significant difference of 6 kg with or without vitamin D supplementation [16 (link)].
The intervention study was analysed per protocol. Comparisons between the groups at baseline and between their delta values (value at end of the study minus value at baseline) were performed with ANOVA, the Kruskall Wallis test or the Chi-square test. The Bonferroni correction was used where multiple comparisons were performed. Unless otherwise stated, data are expressed as mean ± SD. All tests were done two-sided, and P-value < 0.05 was considered statistically significant. The Statistical Package for Social Sciences version 15.0 was used for all statistical analyses (SPSS Inc., Chicago, Ill., USA).
The power calculation was performed according to the primary end point (weight loss) to disclose a clinically significant difference of 6 kg with or without vitamin D supplementation [16 (link)].
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