Comparison of the outcome measures at follow up visits
| Haemoglobin (g/l) | Serum ferritin (μg/dl)* | Peripheral smear | Head circumference (cm) | Weight (g) | Length (cm) | |||
|---|---|---|---|---|---|---|---|---|
| NCHC | MCHC | NCNC | ||||||
| Results expressed as mean±SD or number (%). | ||||||||
| *Means indicated are geometric means except those depicted under change in outcome measures (arithmetic means). | ||||||||
| †The change in haemoglobin has been adjusted for infant age, infant baseline haemoglobin, infant ferritin, and maternal haemoglobin. | ||||||||
| Calculated by Mann-Whitney ranking test. | ||||||||
| b is the regression coefficient, SE (b) is the standard error of b. | ||||||||
| IS group, iron supplementation group; P group, placebo group. | ||||||||
| MCHC, microcytic hypochromic; NCHC, normocytic hypochromic; NCNC, normocytic normochromic. | ||||||||
| INFANTS AVAILABLE AT FIRST FOLLOW UP (n = 62) | ||||||||
| Outcome measures at first follow up | ||||||||
| IS group (n = 32) | 114±9 | 108.0±2.3 | 5 (15.6) | 1 (3.1) | 26 (81.25) | 38.5±1.6 | 4663±535 | 54.4±2.3 |
| P group (n = 30) | 110±11 | 124.1±2.5 | 6 (20.0) | 1 (3.3) | 23 (76.7) | 38.4±1.8 | 4771±469 | 54.9±2.2 |
| Mean difference (95% CI) | 3.6 (−1.7 to 8.4) | – | – | – | – | 0.12 (−0.7 to 1.0) | −108 (−364 to 148) | −0.48 (−1.6 to 0.6) |
| p value | 0.19 | 0.356 | 0.950 | 0.700 | 0.954 | 0.398 | ||
| Change in outcome measures from baseline to first follow up | ||||||||
| IS group (n = 32) | −1.4±11 | −64.2±91.2 | – | 2.1±0.6 | 875.7±282.7 | 3.0±1.1 | ||
| P group (n = 30) | −6.8±9 | −65.0±119.8 | – | 2.3±0.7 | 912.3±224.0 | 3.0±1.3 | ||
| Mean difference (95% CI) | 5.3 (0.2 to 10.5) | 0.78 (−53.1 to 54.6) | – | −0.17 (−0.48 to 0.14) | −36.7 (−166.8 to 93.4) | 0.05 (−0.54 to 0.64) | ||
| p value | 0.042 | 0.274 | – | 0.280 | 0.575 | 0.871 | ||
| INFANTS AVAILABLE AT SECOND FOLLOW UP (n = 26) | ||||||||
| Outcome measures at second follow up | ||||||||
| IS group (n = 13) | 117±9 | 83.8±2.0 | 4 (30.7) | 1 (7.7) | 8 (61.5) | 40.5±1.8 | 5669±475 | 58.9±2.9 |
| P group (n = 13) | 107±12 | 88.4±2.6 | 3 (23.1) | 1 (7.7) | 9 (69.2) | 40.9±2.1 | 5523±370 | 57.3±2.0 |
| Mean difference (95% CI) | 9.8 (0.9 to 18.9) | – | – | – | – | −0.238 (−1.8 to 1.3) | 148 (−199 to 491) | 1.6 (−0.4 to 3.5) |
| p value | 0.03 | 0.681 | 0.736 | 0.310 | 0.390 | 0.108 | ||
| Change in outcome measures from baseline to second follow up | ||||||||
| IS group (n = 13) | 1.4 | −121.1 | – | 3.8±1.0 | 1684.6±535 | 6.6±2.1 | ||
| P group (n = 13) | −6.8 | −111.3 | – | 4.5±1.4 | 1653.8±260 | 5.2±1.3 | ||
| Mean difference (95% CI) | 8.2 (−0.4 to 16.8) | −9.61 (−113 to 94) | – | −0.75 (−1.76 to 0.26) | 30.7 (−310 to 371) | −1.33 (−0.07 to 2.73) | ||
| p value | 0.062 | 0.837 | – | 0.061 | 0.854 | 0.138 | ||
| Adjusted† change in infant haemoglobin | ||||||||
| Variable | b | SE (b) | 95% CI for b | p value | R2 | F-test: p value | ||
| First follow up (n = 62) | ||||||||
| Group (0 = iron,1 = placebo) | 4.66 | 2.07 | 0.052 to 0.880 | 0.024 | 0.471 | <0.001 | ||
| Second follow up (n = 26) | ||||||||
| Group (0 = iron,1 = placebo) | 8.60 | 3.25 | 0.180 to 1.540 | 0.016 | 0.582 | 0.003 | ||