Table 3.
Intent to Treat, Comparison of biomarkers at three time points, per study group
| Biomarker | Controla [n] | Interventionb [n] | P-valuec |
|---|---|---|---|
| Vitamin B12 (pg/mL) | |||
| Baseline | 177.3±2.3 [93] | 226.5±2.1 [105] | 0.14 |
| Month 6 | 189.1±2.0 [97] | 248.5±2.0 [110] | 0.03 |
| Month 12 | 227.0±2.2 [99] | 285.3±2.0 [122] | 0.08 |
| Vitamin B12 deficiencyd (%) | |||
| Baseline | 58.1 [93] | 47.6 [105] | 0.25 |
| Month 6 | 67.0 [93] | 43.6 [105] | 0.01 |
| Month 12 | 61.6 [99] | 48.3 [122] | 0.09 |
| CRP (mg/L) | |||
| Baseline | 0.75±4.2 [97] | 1.35±5.2 [115] | 0.03 |
| Month 6 | 0.89±4.7 [96] | 0.78±4.4 [114] | 0.60 |
| Month 12 | 0.74±6.2 [99] | 0.73±6.8 [121] | 0.96 |
| CRP >3 mg/L (%) | |||
| Baseline | 18.6 [97] | 33.0 [115] | 0.02 |
| Month 6 | 21.9 [96] | 16.7 [114] | 0.43 |
| Month 12 | 23.2 [99] | 20.7 [121] | 0.53 |
| Folate (ng/mL)e | |||
| Baseline | 17.36±1.4 [93] | 17.66±1.5 [110] | 0.76 |
| Month 6 | 16.65±1.4 [97] | 18.48±1.5 [115] | 0.06 |
| Month 12 | 16.25±1.4 [99] | 18.73±1.4 [122] | 0.002 |
| Hemoglobin (g/L)f | |||
| Baseline | 101.8±1.2 [134] | 106.7±1.1 [144] | 0.10 |
| Month 6 | 102.5±1.2 [128] | 106.6±1.2 [144] | 0.17 |
| Month 12 | 105.7±1.1 [109] | 108.7±1.1 [134] | 0.14 |
| Anemia (%)f | |||
| Baseline | 50.0 [134] | 39.6 [144] | 0.18 |
| Month 6 | 65.6 [128] | 50.7 [144] | 0.07 |
| Month 12 | 55.1 [109] | 51.5 [134] | 0.60 |
| Transferrin receptors (μg/mL) | |||
| Baseline | 8.11±1.6 [97] | 8.70±1.5 [115] | 0.26 |
| Month 6 | 7.81±1.7 [96] | 8.20±1.6 [112] | 0.55 |
| Month 12 | 7.62±1.5 [98] | 7.11±1.8 [122] | 0.63 |
| Transferrin >8.3 μg/mL (%) | |||
| Baseline | 49.5 [97] | 52.2 [115] | 0.68 |
| Month 6 | 45.8 [96] | 49.1 [112] | 0.67 |
| Month 12 | 28.6 [98] | 26.2 [122] | 0.86 |
| Zinc (μg/dL) | |||
| Baseline | 62.4±1.6 [109] | 66.2±1.4 [128] | 0.35 |
| Month 6 | 65.6±1.3 [91] | 64.9±1.3 [111] | 0.84 |
| Month 12 | 63.4±1.2 [77] | 65.1±1.2 [99] | 0.55 |
| Zinc <65 μg/dL (%) | |||
| Baseline | 47.7 [109] | 37.5 [128] | 0.42 |
| Month 6 | 51.7 [91] | 54.1 [111] | 0.83 |
| Month 12 | 62.3 [77] | 55.6 [99] | 0.48 |
| Retinol (μmol/L)f | |||
| Baseline | 0.75±1.3 [82] | 0.80±1.3 [97] | 0.006 |
| Month 6 | 0.82±1.3 [89] | 0.92±1.2 [102] | 0.03 |
| Month 12 | 0.82±1.4 [75] | 0.88±1.3 [96] | 0.34 |
| Vitamin A Deficiency (Retinol <0.70 μmol/L) (%)g | |||
| Baseline | 45.1 [82] | 26.8 [97] | <0.0001 |
| Month 6 | 25.8 [89] | 13.7 [102] | 0.19 |
| Month 12 | 33.3 [75] | 17.7 [96] | 0.03 |
| Riboflavin (nmol/L) | |||
| Baseline | 215.9±1.7 [92] | 254.4±1.4 [134] | 0.11 |
| Month 6 | 273.5±1.4 [78] | 277.3±1.4 [52] | 0.89 |
| Month 12 | 261.4±1.3 [86] | 265.1±1.3 [117] | 0.78 |
| Riboflavin <170 nmol/L (%) | |||
| Baseline | 20.7 [92] | 8.2 [134] | 0.18 |
| Month 6 | 6.4 [78] | 11.5 [52] | 0.31 |
| Month 12 | 4.7 [86] | 3.4 [117] | 0.70 |
Geometric means and geometric standard deviation.
P-values based on GEE analysis using PROC GENMOD, taking into account randomization at village level.
Cut points were <167.9 pg/ml for 5–11 mo old, <266.79 pg/ml for 11–24 mo olds, and <319.6 for >24 mo olds.
There were no cases of folate deficiency defined as <3 ng/mL at any time point.
Hemoglobin values adjusted for altitude. Cut points were <100 g/L for <12 mo olds, <110 g/L for 12 to 24 mo olds, and <111 g/l for 2 to 5 yr olds.
P-values for retinol and vitamin A deficiency based on GEE analysis using PROC GENMOD, taking into account randomization at village level and adjusted for baseline value and time point-specific measured CRP level.