Table 2.
Baseline characteristics, by intervention group
| Characteristic | Placebo | Iron, 3 mg as NaFeEDTA | Iron, 12.5 mg as ferrous fumarate |
|---|---|---|---|
| Number (n) | 112 | 112 | 114 |
| General characteristics | |||
| Sex, male | 69 (61.6%) | 61 (54.5%) | 56 (49.1%) |
| Age, months | 22.8 (6.8) | 23.2 (6.2) | 24.9 (6.4) |
| Age class | |||
| 12–23 months | 61 (54.5%) | 57 (50.9%) | 44 (38.6%) |
| 24–36 months | 51 (45.5%) | 55 (49.1%) | 70 (61.4%) |
| Nutritional markers | |||
| Haemoglobin concentration, g/L | 104.4 (13.2) | 105.9 (13.3) | 104.7 (13.3) |
| Anaemia | |||
| Moderate (haemoglobin concentration 70–99.99 g/L) | 33 (29.5%) | 34 (30.4%) | 36 (31.6%) |
| Mild (haemoglobin concentration 100–109.99 g/L) | 39 (34.8%) | 31 (27.7%) | 37 (32.5%) |
| No anaemia (haemoglobin concentration ≥110 g/L) | 40 (35.7%) | 47 (42.0%) | 41 (36.0%) |
| ZPP:haem ratio, μmol:mola | |||
| In whole blood | 170 (119; 305) | 172 (102; 260) | 196 (137; 283) |
| In erythrocytes | 130 (84; 301) | 141 (76; 223) | 160 (101; 246) |
| Plasma ferritin concentration, μg/La,b | 37.7 (17.3; 74.0) | 31.4 (16.0; 56.6) | 36.9 (17.6; 68.8) |
| Iron statusb | |||
| Deficient (plasma ferritin concentration <12 μg/L) | 17 (15.2%) | 20 (18.3%) | 20 (17.9%) |
| Replete (plasma ferritin concentration ≥12 μg/L in the absence of inflammation) | 26 (23.2%) | 32 (29.4%) | 19 (17.0%) |
| Uncertain (plasma ferritin concentration ≥12 μg/L in the presence of inflammation) | 69 (61.6%) | 57 (52.3%) | 73 (65.2%) |
| Iron deficiency, based on adjusted ferritin concentrationsb,c | 52.7% (59/112) | 57.8% (63/109) | 49.1% (55/112) |
| Plasma soluble transferrin receptor concentration, mg/La | 2.41 (1.75; 3.46) | 2.39 (1.82; 3.16) | 2.60 (1.93; 3.41) |
| Plasma albumin concentration, g/L | 34.6 (3.9) | 35.0 (3.5) | 34.7 (4.1) |
| Vitamin B12 concentration, pmol/L | 391 (291; 557) | 409 (311; 569) | 401 (315; 554) |
| Infection and inflammation markers | |||
| Plasma C-reactive protein concentration, mg/La | 2.5 (0.7; 7.6) | 2.5 (0.6; 7.8) | 4.5 (1.3; 11.0) |
| Plasma α 1-acid glycoprotein concentration, g/La | 1.20 (0.90; 1.57) | 1.08 (0.81; 1.47) | 1.17 (0.97; 1.63) |
| Inflammation | |||
| Plasma C-reactive protein concentration >5 mg/L | 40 (35.7%) | 35 (31.3%) | 53 (46.5%) |
| Plasma α 1-acid glycoprotein concentration >1 g/L | 71 (63.4%) | 63 (56.3%) | 81 (71.1%) |
| Plasma C-reactive protein concentration >5 mg/L or plasma α 1-acid glycoprotein concentration >1 g/L | 77 (68.8%) | 65 (58%) | 84 (73.7%) |
| Plasmodium antigenaemia, by rapid dipstick testsd | |||
| P. falciparum (either HRP2 or P. falciparum-specific pLDH) | 39 (35.1%) | 40 (36.0%) | 43 (38.1%) |
| Plasmodium species other than P. falciparum (pLDH specific for P. malariae, P. ovale or P. vivax)e | 1 (0.9%) | 2 (1.8%) | 0 |
| Any Plasmodium species | 39 (35.1%) | 41 (36.9%) | 43 (38.1%) |
| Blood smear tests, by microscopy | |||
| Asexual or sexual forms of P. falciparum | 47 (41.9%) | 49 (43.8%) | 55 (48.2%) |
| Asexual forms of both P. falciparum and human Plasmodium spp. other than P. falciparum (i.e. P. malariae, P. ovale or P. vivax) | 2 (1.8) | 1 (0.8) | 2 (1.8) |
| Asexual parasite density for P. falciparum, μ/La | 757 (172; 3972) | 3340 (297; 20,023) | 1048 (207; 6820) |
| Low (<1000 μ/L) | 17 (15.2%) | 9 (8.0%) | 19 (16.7%) |
| Medium (1000–9999 μ/L) | 12 (10.7%) | 8 (7.1%) | 15 (13.2%) |
| High (≥10,000 μ/L) | 3 (2.7%) | 7 (6.3%) | 5 (4.4%) |
| Gametocyte density, μ/La | 326 (49; 732) | 82 (37; 120) | 1126 (57; 2679) |
| Anthropometric markers | |||
| Body height, cm | 80.9 (5.9) | 82.1 (5.7) | 82.4 (5.1) |
| Body weight, kg | 10.6 (1.8) | 10.8 (2.0) | 10.9 (1.7) |
| Height-for-age z-score, SD | –1.42 (1.47) | –1.15 (1.43) | –1.43 (1.31) |
| Weight-for-height z-score, SD | –0.10 (1.05) | –0.16 (1.07) | –0.14 (0.93) |
| Weight-for-age z-score, SD | –0.81 (1.18) | –0.71 (1.22) | –0.86 (1.09) |
| Stunted (height-for-age z-score < –2 SD) | 34 (30.4%) | 31 (27.7%) | 37 (32.5%) |
| Wasted (weight-for-height z-score < –2 SD) | 3 (2.7%) | 5 (4.5%) | 2 (1.8%) |
| Underweight (weight-for-age z-score < –2 SD) | 19 (17.0%) | 12 (10.7%) | 15 (13.2%) |
Values indicate n (%), mean (SD) or amedian (25th and 75th percentiles). HRP2 histidine-rich protein-2, pLDH P. falciparum-specific lactate dehydrogenase
bDue to missing values for ferritin concentrations in 5 children, n was 112, 109 and 112 for groups that received placebo, NaFeEDTA and ferrous fumarate, respectively; cbased on ferritin concentrations adjusted for inflammation by linear regression (see text)
dDue to missing values in 3 children, n was 111, 111 and 113 for groups that received placebo, NaFeEDTA and ferrous fumarate, respectively
eOne child in placebo group and 1 child in NaFeEDTA group with antigenaemia due to P. malariae or P. ovale or P. vivax also had antigenaemia to P. falciparum (mixed infection)