Table 5.

Side effect profile before and during treatment

Adverse EffectBaselinePlaceboOral Sodium Bicarbonate Dose (mEq/kg per day)P Value
0.30.61.0
Gastrointestinal symptoms
 Bloating3 (15)4 (20)2 (10)2 (10)4 (22)0.96
 Flatulence10 (50)15 (75)11 (55)12 (60)10 (55)0.39
 Stomach upset3 (15)4 (20)3 (15)3 (15)3 (11)0.84
 Nausea3 (15)2 (10)0 (0)3 (15)4 (22)0.28
 Total12 (60)16 (80)11 (55)12 (60)11 (61)0.24
Edema0.61
 None11 (55)12 (60)13 (65)11 (55)10 (55)
 1+7 (35)5 (25)4 (20)6 (30)7 (39)
 2+2 (10)3 (15)3 (15)3 (15)1 (6)
Shortness of breath4 (20)1 (5)1 (5)3 (15)2 (11)0.97
Hospitalization00000
  • Data are expressed as number (%). Data are presented for all 20 participants at each time point except for the 1.0-mEq/kg per day dose, when 18 participants remained in the study.