Hansen 2002.
Methods | RCT. Duration 4 years. | |
Participants | 82 type 1 patients (18‐60 yrs) with diabetic retinopathy, albuminuria >= 300 mg/24 hr. GFR above 20ml/min/1.73 m2 and a pre‐study decline in GFR >=2 ml/min/year (progressive diabetic nephropathy). Mean duration of diabetes LPD 28 years, UPD 27 years. | |
Interventions | LPD = 0.6 g/kg/day. Supplementation of calcium of 500 mg/day (n=38). UPD = patients' pre‐study diet (n=34). | |
Outcomes | GFR. RR of ESRD or death. Malnutrition assessed by mid‐arm circumference, serum albumin and body weight. Compliance monitored by dietary interview and uU. Actual protein intake 0.89 g/kg/day. | |
Notes | Comparable number in both groups received antihypertensives and ACE but +4 at follow‐up on antihypertensive and +4 on ACE. Malnutrition indicators comparable in 2 groups, but data not shown. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |