Table 2

Details of subject selection criteria of included studies

Study nameSubject selection criteriaActive vitamin D usePhosphate binder useCinacalcet (or other calcimimetic agent) use
Massart et al19No 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.YesYes
Mieczkowski et al8Total 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.NRNo use within 6 months prior to enrollment
Mose et al20No 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 study23/25 did not change dose, 1 increased and 1 decreased doses during the study
Hewitt et al12No 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 studyUsed but dosage unchanged for 4 weeks prior to studyNo
Delanaye et al17Subjects 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 excludedNo ergo or cholecalciferol used within the past year.Yes, and no dosage change during the study was reportedNo use within l year
Seibert et al11Without 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 glycosidesNo pre-existing cholecalciferol supplementation. For other pre-existing vitamin D: no dose adjustment in all except one pt increased slightly in 11th weekAdjusted based on K/DOQI 2003 recommendationsPre-existing use in 1/15 in study and 3/18 in placebo group; whether dose changed during study is not reported
Marckmann et al21No 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 excludedYes, and almost all patients (except one who stopped using sevelamer) had no dosage changed during studyNot reported for HD patients, but yes for the overall group with dosage unchanged during study.
Armas et al22Exclude those who were not ambulatory, were unable to complete the questionnaire with a research nurse, or had unusual difficulty with venous access. PD patients.NRNRNR
Wasse (2012)23Those 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 dayNRNR
  • HD, hemodialysis; NKF-KDOQI, National Kidney Foundation–Kidney Disease Outcomes Quality Initiative); NR, not reported; PD, peritoneal dialysis; PTH, parathyroid hormone.