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. 2015 Sep 16;2015(9):CD010350. doi: 10.1002/14651858.CD010350.pub2

Herselman 1995.

Methods

  • Study design: RCT

  • Duration of study: 9 months
Participants

  • Country: South Africa

  • Setting: outpatient clinic

  • Diagnostic criteria: history of confirmed CKD for at least 6 months; SCr 150 to 700 µmol/L; no evidence of diabetes mellitus, liver disease, alcoholism, underlying malignancy or psychiatric disorders; no prescription for corticosteroids, cyclophosphamide, angiotensin‐converting enzyme inhibitors, calcium entry blockers or other bone toxic drugs

  • Number: (treatment group (11); control group (11)

  • Mean age ± SD (years): treatment group (42 ± 13); control group (43 ± 15)

  • Sex (M/F): treatment group (7/4); control group (5/6)
Interventions Patients received the same standard of counselling. Each patient was supplied with food scales for the weighing of food, and was visited at home to optimise education. Following the training period of 8 weeks, patients were matched for underlying nephropathy, SCr, creatinine clearance, known duration of disease, age, sex and dietary knowledge, then randomised.
Treatment group

  • 0.4 g protein/kg/d supplemented with essential amino acids


Control group

  • 0.6 g protein/kg/d
Outcomes

  • Serum phosphorus (mmol/L)

  • Serum calcium (mmol/L)

  • PTH (pmol/L)

  • Alkaline phosphatase (U/L)
Notes

  • Funding: "supported by grants from Kabi Vitrum AB, Stockholm, Sweden; Adcock‐Ingram Laboratoris Ltd, South Africa, and Roussel Laboratories (Pty) Ltd, South Africa"
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not reported
Allocation concealment (selection bias) Unclear risk Not reported
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Not reported
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not reported
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No missing data at nine months follow‐up
Selective reporting (reporting bias) Low risk Published report included all specified outcomes
Other bias Unclear risk Insufficient information to permit judgement