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

Isakova 2013.

Methods
  • Study design: RCT

  • Study time frame: July 2009 to March 2012

  • Duration of study: 3 months

Participants
  • Country: USA

  • Setting: clinical research centre

  • Diagnostic criteria: eGFR of 15‐59 mL/min/1.73 m2 on the basis of the Modification of Diet in Renal Disease equation, and had normal phosphate levels (2.5 to 4.6 mg/dL)

  • Number: treatment group A (10); control group A (10); treatment group B (8); control group B (11)

  • Mean age ± SD (years): treatment group A (56.2 ± 10.1); control group B (55.1 ± 12.6); treatment group B (56.1 ± 10.0); control group B (54.3 ± 9.8)

  • Sex (M/F): treatment group A (7/3); control group A (5/5); treatment group B (5/3); control group B (8/3)

  • Comorbidity: not reported

  • Exclusion criteria: hyperphosphataemia; rapidly advancing CKD, primary hyper‐ or hypoparathyroidism or prior parathyroidectomy; malabsorption; malnutrition, liver disease; cholestasis; anaemia; received prior counselling by a nutritionist within 6 months; taking phosphate binders; hospitalised within the previous 4 weeks; pregnant or breastfeeding mothers; unable to provide written informed consent

Interventions All participants met with the dietitian, who provided personalized dietary recommendations during a 60‐minute session at the randomisation visit and at 30‐minute follow‐up visits during weeks 2, 8, and 12, when adherence with the dietary intervention was reassessed with 3‐day food records. Dietitian used the food records to counsel participants to follow a diet tailored to their randomisation group.
Treatment group A
  • 900‐mg phosphate diet

  • Lanthanum carbonate placebo


Control group A
  • ad libitum diet

  • Lanthanum carbonate placebo


Treatment group B
  • 900 mg phosphate diet

  • Lanthanum carbonate (1000 mg, 3 times/d with meals)


Control group B
  • ad libitum diet

  • Lanthanum carbonate (1000 mg, 3 times/d with meals)

Outcomes
  • Serum phosphorus (mg/dL)

  • FGF‐23 (RU/mL)

  • PTH (pg/mL)

Notes
  • Funding: "supported by a grant from Shire Pharmaceuticals and by grants from the National Institutes of Health and the National Institute of Diabetes and Digestive and Kidney Diseases: K23DK087858 (T.I.), R01DK076116 (M.W.) and R01DK081374 (M.W.)"

  • "Shire Pharmaceuticals gave full rights of publication to the investigators. Shire did review the manuscript but did not participate in the conceptual design, data analysis, interpretation of the results, or writing of the manuscript"

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 High risk Dietitian and participants were unblinded to the assigned dietary counselling group
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk The investigators remained blinded to the dietary group
Incomplete outcome data (attrition bias) 
 All outcomes High risk Imbalance in numbers and reasons for missing data across intervention groups
Selective reporting (reporting bias) High risk Data did not show all of the study's pre‐specified primary outcomes
Other bias Unclear risk Insufficient information to permit judgement