Massart et al19 | No hypersensitivity to study medications, pregnancy or lactation period, women without effective contraception, and plasma calcium level 10.2 mg/dL, prior para-thyroidectomy, no granulomatous disorder, no active malignancy, and/or estimated life expectancy of at least 1 year. | No paricalcitol, alfacalcidol, cholecalciferol and/or calcitriol dosage adjustment 1 month prior to enrollment. | Yes | Yes |
Mieczkowski et al8 | Total serum calcium concentrations of 2.55 mmol/L, serum phosphate of 2.08 mmol/L, not taking any vitamin D supplement, calcitriol, its analogs, or calcimimetic within the past 6 months, and no serious overall condition or cachexia. | No use within 6 months prior to enrollment. | NR | No use within 6 months prior to enrollment |
Mose et al20 | No malignant disease, no hypercalcemia (albumin corrected serum calcium >2.60 mmol/L), no intolerance toward cholecalciferol tablets. | Supplementation of more than 10 μg of ergo or cholecalciferol daily was paused 3 months prior to baseline measurement. | Yes, fewer than half of the subjects had the dose changed during the study | 23/25 did not change dose, 1 increased and 1 decreased doses during the study |
Hewitt et al12 | No parathyroid surgery or treatment with cinacalcet in the preceding 3 months, no hypercalcemia defined as albumin corrected serum calcium 10.4 mg/dL (2.60 mmol/L), no bisphosphonate treatment at any time, and no planned surgery except for dialysis access. | Used but no dose adjustment for 4 weeks prior to study | Used but dosage unchanged for 4 weeks prior to study | No |
Delanaye et al17 | Subjects without hepatic failure, sarcoidosis, digestive malabsorption or hypercalcaemia, with intact PTH levels >800 pg/mL or PTH >400 pg/mL with a duplicate value over the last 3 months were excluded | No ergo or cholecalciferol used within the past year. | Yes, and no dosage change during the study was reported | No use within l year |
Seibert et al11 | Without pregnancy or lactation, known malignancy, liver disease, defined as 2-fold upper limit of ASAT, or ALAT levels, PTH 50 pg/mL, no current infections, chronic viral infection, not taking immunosuppressive medication, and no hematologic disorders other than renal anemia, no anaphylactic reaction against the study medication, no renal calculus, no pseudohypopara-thyroidism, no sarcoidosis, and no intake of cardiac glycosides | No pre-existing cholecalciferol supplementation. For other pre-existing vitamin D: no dose adjustment in all except one pt increased slightly in 11th week | Adjusted based on K/DOQI 2003 recommendations | Pre-existing use in 1/15 in study and 3/18 in placebo group; whether dose changed during study is not reported |
Marckmann et al21 | No hypercalcemia or severe hyperphosphatemia (P-phosphate >2.2 mmol/L at two consecutive measurements >1 week apart), no sarcoidosis, malignant disease, psychotic disorder, alcohol or drug abuse, pregnancy, breastfeeding, or allergy toward soy protein, and no estrogen use or not on safe contraception for fertile women. | Supplementary of a total of >10,000 IU ergo or cholecalciferol within the past 3 months was excluded | Yes, and almost all patients (except one who stopped using sevelamer) had no dosage changed during study | Not reported for HD patients, but yes for the overall group with dosage unchanged during study. |
Armas et al22 | Exclude those who were not ambulatory, were unable to complete the questionnaire with a research nurse, or had unusual difficulty with venous access. PD patients. | NR | NR | NR |
Wasse (2012)23 | Those who had a corrected serum calcium >10.5 mg/dL within 4 weeks of study screening were excluded. | Excluded if taking >2000 IU vitamin D2 (ergocalciferol) or D3 (cholecalciferol) per day | NR | NR |