Methods |
|
Participants |
Country: Thailand
Setting: university teaching hospital
Aged < 18 years. CKD stage 5/5D, vitamin D deficiency with levels < 30 ng/mL, Hb level 10.0 to 12.5 g/dL, serum phosphorus, 6.5 mg/dL, corrected Ca < 10.5 mg/dL, Ca x P, 65mg2/dL2 one month prior to recruitment
Number: treatment group (10); control group (10)
Mean age ± SD (years): treatment group (7.1 ± 5.4); control group (9.3 ± 5.3)
Sex (M/F): treatment group (7/3); control group (6/4)
Exclusion criteria: thalassaemia; chronic liver disease; gastrointestinal malabsorption; significant blood loss; PTH > 800 pg/mL; proteinuria > 2 mg/mg of urine creatinine; blood transfusion; chronic anticonvulsant therapy; prior ergocalciferol supplementation and kidney transplantation
|
Interventions |
Treatment group
Severe vitamin D deficiency (serum 25D level < 5 ng/mL) 40,000 IU ergocalciferol weekly for 4 weeks, then 40,000 IU every second week for 8 weeks (total 320,000 IU ergocalciferol)
Mild deficiency (serum 25D level 5 to 15 ng/mL) 40,000 IU ergocalciferol every second week for 12 weeks (total 240,000 IU ergocalciferol)
For 25D insufficiency (serum 25D levels 16 to 30 ng/mL) 40,000 IU ergocalciferol every 4 weeks for 12 weeks (total 120,000 IU ergocalciferol)
Control group
Co‐interventions
Calcium carbonate for phosphate binding with phosphorus level > 5.5 mg/dL
Alfacalcidol for secondary hyperparathyroidism
Anaemia management: epoetin alfa administered subcutaneously
|
Outcomes |
Ca levels
PTH levels
Phosphorous levels
|
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
High risk |
Simple randomisation, randomisation was sequentially done (information from authors) |
Allocation concealment (selection bias) |
High risk |
Simple randomisation, randomisation was sequentially done (information from authors) |
Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Not blinded and lack of blinding could affect patient management |
Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Laboratory outcome and unlikely to be influenced by lack of blinding |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
All patients completed 12 week therapy |
Selective reporting (reporting bias) |
Low risk |
All prespecified outcomes mentioned |
Other bias |
Unclear risk |
Insufficient information to permit judgement |