Table 2.
Study (Reference) | Study Type | Sample Size | Control Group | Randomized | Results | Limitations |
---|---|---|---|---|---|---|
Chandra et al. (67) | Double-blind, placebo-controlled, randomized controlled pilot study | 20 | Yes | Yes | Among cholecalciferol-treated participants, serum 25(OH)D concentration increased on average from 17.3 ng/ml (95% CI, 11.8–25.2) at baseline to 49.4 ng/ml (95% CI, 33.9–-72.0) at week 12. As-treated analysis indicated a trend toward lower PTH levels among cholecalciferol-treated participants (P=0.07) | Small study |
Short follow-up period | ||||||
Dogan et al. (66) | Randomized | 40 | Yes | Yes | Administration of depot oral cholecalciferol (300,000 IU vitamin D3) resulted in a significant increase in calcidiol (6.8±3.5 to 17.8±21.4 ng/ml, P<0.001), significant decrease in iPTH (368±274 to 279±179 pg/ml, P<0.001). No statistically significant change in Ca, P, Ca × P, and urinary calcium creatinine rate was observed | Small study |
Short follow-up period | ||||||
Methodology does not specify whether investigators were blinded to the intervention | ||||||
Oksa et al. (68) | Randomized | 87 | No | Yes | Vitamin D insufficiency/deficiency in CKD significantly improved after the 12-mo cholecalciferol treatment, with more significant improvement with higher dose (20,000 IU/wk) being more effective and equally safe | Lack of a placebo control |
The inclusion of a subgroup of patients who received calcium carbonate for correction of metabolic acidosis is a potential confounder | ||||||
Kovesdy et al. (17) | Randomized, not blinded | 80 | Active | Randomized | 80 CKD patients randomized to ergocalciferol versus paricalcitol. Paricalcitol group showed lower PTH levels than ergocalciferol group | Not blinded |
Differential initiation of phosphate binders in the two groups |
95% CI, confidence interval; PTH, parathyroid hormone.