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. 2015 Nov 12;2015(11):CD008327. doi: 10.1002/14651858.CD008327.pub2

Rianthavorn 2013.

Methods
  • Study design: RCT

  • Time frame: not reported

  • Follow‐up period: not reported

  • Loss to follow‐up/excluded: none reported

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
  • No specific therapy


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
  • Primary outcome was the effect of ergocalciferol on ESA dose

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