TABLE 3.
Unadjusted mean difference, µg/L | P value2 | Adjusted mean difference,3 µg/L | P value2 | |
---|---|---|---|---|
Human milk total thiamine concentration,4 µg/L | ||||
1.2 mg − placebo (0 mg) | 29.05 (12.17, 45.94) | <0.0001 | 30.09 (13.30, 46.88) | <0.0001 |
2.4 mg − placebo (0 mg) | 38.66 (19.88, 57.45) | <0.0001 | 39.84 (21.21, 58.47) | <0.0001 |
2.4 mg − 1.2 mg | 9.61 (−8.32, 27.54) | 0.5 | 9.75 (−7.99, 27.49) | 0.5 |
10 mg − placebo (0 mg) | 37.25 (18.71, 55.79) | <0.0001 | 38.65 (20.35, 56.95) | <0.0001 |
10 mg − 1.2 mg | 8.19 (−9.30, 25.68) | 0.6 | 8.56 (−8.85, 25.97) | 0.6 |
10 mg − 2.4 mg | −1.42 (−20.93, 18.10) | 1.0 | −1.19 (−20.20, 17.93) | 1.0 |
Overall | <0.0001 | <0.0001 | ||
Whole blood ThDP,5 nmol/L | ||||
Mother | ||||
1.2 mg − placebo (0 mg) | 43.03 (12.02, 74.05) | 0.002 | 43.17 (12.64, 73.70) | 0.002 |
2.4 mg − placebo (0 mg) | 46.24 (13.17, 79.32) | 0.002 | 46.01 (13.36, 78.66) | 0.002 |
2.4 mg − 1.2 mg | 3.21 (−30.28, 36.71) | 1 | 2.84 (−30.14, 35.82) | 1 |
10 mg − placebo (0 mg) | 77.23 (44.79,109.67) | <0.0001 | 76.78 (44.81,108.76) | <0.0001 |
10 mg − 1.2 mg | 34.19 (1.96, 66.42) | 0.03 | 33.61 (1.93, 65.29) | 0.03 |
10 mg − 2.4 mg | 30.98 (−2.63, 64.59) | 0.08 | 30.77 (−2.40, 63.95) | 0.08 |
Overall | <0.0001 | <0.0001 | ||
Infant | ||||
1.2 mg − placebo (0 mg) | 56.60 (24.50, 88.69) | <0.0001 | 57.01 (25.31, 88.72) | <0.0001 |
2.4 mg − placebo (0 mg) | 42.04 (7.52, 76.55) | 0.01 | 42.35 (8.00, 76.70) | 0.009 |
2.4 mg − 1.2 mg | −14.56 (−50.71, 21.58) | 0.7 | −14.66 (−50.52, 21.20) | 0.7 |
10 mg − placebo (0 mg) | 47.31 (16.02, 78.61) | 0.0007 | 46.83 (15.88, 77.78) | 0.0007 |
10 mg − 1.2 mg | −9.29 (−40.65, 22.08) | 0.9 | −10.18 (−41.22, 20.86) | 0.8 |
10 mg − 2.4 mg | 5.28 (−27.80, 38.35) | 1 | 4.48 (−28.22, 37.18) | 1 |
Overall | <0.0001 | <0.0001 | ||
ETKac5 | ||||
Mother | ||||
1.2 mg − placebo (0 mg) | −0.05 (−0.08, −0.01) | 0.004 | −0.05 (−0.08, −0.01) | 0.004 |
2.4 mg − placebo (0 mg) | −0.06 (−0.09, −0.02) | 0.0002 | −0.06 (−0.09, −0.02) | 0.0002 |
2.4 mg − 1.2 mg | −0.01 (−0.04, 0.02) | 0.7 | −0.01 (−0.04, 0.02) | 0.7 |
10 mg − placebo (0 mg) | −0.07 (−0.11, −0.04) | <0.0001 | −0.07 (−0.11, −0.04) | <0.0001 |
10 mg − 1.2 mg | −0.03 (−0.06, 0.00) | 0.1 | −0.03 (−0.06, 0.00) | 0.1 |
10 mg − 2.4 mg | −0.02 (−0.05, 0.02) | 0.7 | −0.02 (−0.05, 0.02) | 0.6 |
Overall | <0.0001 | <0.0001 | ||
Infant | ||||
1.2 mg − placebo (0 mg) | −0.04 (−0.08, 0.01) | 0.1 | −0.04 (−0.08, 0.01) | 0.1 |
2.4 mg − placebo (0 mg) | −0.04 (−0.09, 0.01) | 0.1 | −0.04 (−0.09, 0.01) | 0.1 |
2.4 mg − 1.2 mg | −0.00 (−0.04, 0.03) | 1 | −0.00 (−0.04, 0.03) | 1 |
10 mg − placebo (0 mg) | −0.06 (−0.10, −0.02) | 0.003 | −0.06 (−0.10, −0.02) | 0.003 |
10 mg − 1.2 mg | −0.02 (−0.06, 0.01) | 0.3 | −0.02 (−0.06, 0.01) | 0.3 |
10 mg − 2.4 mg | −0.02 (−0.06, 0.02) | 0.6 | −0.02 (−0.06, 0.02) | 0.6 |
Overall | 0.009 | 0.009 |
Data are mean differences (95% CIs) unless otherwise indicated. Results are based on analysis of 100 imputed datasets. ETKac, erythrocyte transketolase activity coefficient; ThDP, thiamine diphosphate concentrations.
Post hoc (Tukey) adjusted P values for multiple comparisons.
Adjustments: human milk concentrations, adjusted for human milk total thiamine at 2 wk and health center; ThDP, adjusted for health center (mother and infant) and maternal thiamine diphosphate concentrations (corrected for hematocrit) at 2 wk (mother only); ETKac, adjusted for health center (mother and infant) and erythrocyte transketolase activity coefficient at 2 wk (mother only).
Linear mixed-effects model was used to analyze the data at 4, 12, and 24 wk with a treatment by time point interaction model. Mean differences between treatment groups collapsed across all time points (4, 12, and 24 wk) are reported, as the treatment by time interaction P value was >0.05 and hence was dropped from the analysis model.
Linear regression was used to estimate the mean differences between treatment groups at 24 wk.