Daily home fortification with iron as ferrous fumarate versus NaFeEDTA: a randomised, placebo-controlled, non-inferiority trial in Kenyan children

Table 3 Effect of daily home fortification with 3 mg iron as NaFeEDTA and 12.5 mg iron as encapsulated ferrous fumarate on continuous outcomes at 30 days after start of intervention, per protocol analysis

Outcome/intervention group	No. (n)	Estimate^a	Effect (95% CI) relative to placebo^b	Effect (95% CI) relative to standard^b
Haemoglobin concentration
Placebo	105	106.9 g/L (13.3 g/L)	Reference	Not applicable
Iron, 3 mg as NaFeEDTA	103	110.0 g/L (12.5 g/L)	3.0 g/L (–0.2 g/L to 6.2 g/L)^c	1.3 g/L (–1.8 g/L to 4.3 g/L)^c
Iron, 12.5 mg as ferrous fumarate	107	108.6 g/L (12.0 g/L)	1.6 g/L (–1.6 g/L to 4.8 g/L)^c	Reference
Plasma ferritin concentration
Placebo	104	29.7 μg/L [3.47]	Reference	Not applicable
Iron, 3 mg as NaFeEDTA	102	33.7 μg/L [2.53]	16.2% (–14.3% to 57.7%)^d	2.5% (–22.4% to 35.4%)^d
Iron, 12.5 mg as ferrous fumarate	105	32.6 μg/L [3.00]	12.3% (–17.1% to 52.0%)^d	Reference
Plasma soluble transferrin receptor concentration
Placebo	105	2.24 mg/L [1.61]	Reference	Not applicable
Iron, 3 mg as NaFeEDTA	103	2.15 mg/L [1.47]	–4.3% (–13.5% to 5.9%)^d	3.6% (–5.5% to 13.6%)^d
Iron, 12.5 mg as ferrous fumarate	106	2.07 mg/L [1.38]	–7.3% (–16.2% to 2.6%)^d	Reference
Erythrocyte ZPP-haem ratio
Placebo	104	136 μmol/mol [2.17]	Reference	Not applicable
Iron, 3 mg as NaFeEDTA	103	127 μmol/mol [1.97]	–6.5% (–23.5% to 14.2%)^d	-5.3% (-21.7% to 14.5%) ^d
Iron, 12.5 mg as ferrous fumarate	106	134 μmol/mol [2.00]	–0.7% (–18.6% to 21.0%)^d	Reference

^aMean (SD) or geometric mean [geometric standard deviation]
^bEffects were adjusted for study design (blocks nested within strata of haemoglobin concentration <100 g/L and ≥100 g/L)
^cEffects were calculated as absolute difference in means
^dExponentiation of group differences with log-transformed outcomes resulted in associations being expressed as relative differences

ISSN: 1741-7015