TABLE 3.
Unadjusted binary outcome measures (anemia and biomarkers of iron status) for infants in the iLiNS-DYAD randomized trial of daily nutrient supplementation in a semiurban setting in Ghana, by intervention group1
| Intervention groups based on supplements mothers were intended to receive when enrolled | Intervention groups based on supplements mothers actually received when enrolled | |||||||
|---|---|---|---|---|---|---|---|---|
| IFA (n = 441) | MMN (n = 439) | LNS (n = 440) | P 2 | IFA (n = 441) | MMN (n = 439) | LNS (n = 440) | P 2 | |
| Anemia3 | ||||||||
| 6 mo | 37.1 (31.9, 42.6) [310] | 35.4 (30.4, 40.7) [325] | 33.5 (28.5, 39.0) [313] | 0.65 | 33.4 (28.4, 38.9) [308] | 38.8 (33.7, 44.2) [327] | 33.5 (28.5, 39.0) [313] | 0.26 |
| 18 mo | 42.6 (37.4, 48.0) [333] | 47.3 (41.9, 52.7) [328] | 38.7 (33.6, 44.1) [328] | 0.09 | 43.9 (38.6, 49.4) [321] | 45.9 (40.6, 51.2) [340] | 38.7 (33.6, 44.1) [328] | 0.16 |
| Anemia4 | ||||||||
| 6 mo | 19.7 (15.6, 24.5) [310] | 19.4 (15.4, 24.1) [325] | 16.6 (12.9, 21.2) [313] | 0.55 | 19.2 (15.1, 23.9) [308] | 19.9 (15.9, 24.6) [327] | 16.6 (12.9, 21.2) [313] | 0.54 |
| 18 mo | 6.0 (3.9, 9.1) [333] | 4.9 (3.0, 7.8) [328] | 4.6 (2.8, 7.5) [328] | 0.68 | 5.6 (3.6, 8.7) [321] | 5.3 (3.4, 8.2) [340] | 4.6 (2.8, 7.5) [328] | 0.83 |
| Elevated ZPP5 | ||||||||
| 6 mo | 31.7 (26.6, 37.2) [300] | 37.7 (32.5, 43.1) [316] | 35.8 (30.5, 41.4) [299] | 0.28 | 34.6 (29.4, 40.1) [301] | 34.9 (29.8, 40.4) [315] | 35.8 (30.5, 41.4) [299] | 0.95 |
| 18 mo | 35.3 (30.3, 40.6) [329] | 34.7 (29.7, 40.0) [323] | 27.5 (22.9, 32.7) [320] | 0.07 | 36.6 (31.5, 42.0)b [317] | 33.4 (28.6, 38.7)ab [335] | 27.5 (22.9, 32.7)a [320] | 0.046 |
| IDA6 | ||||||||
| 6 mo | 19.0 (14.9, 23.8) [300] | 18.7 (14.7, 23.4) [316] | 19.7 (15.6, 24.6) [299] | 0.94 | 17.9 (14.0, 22.7) [301] | 19.7 (15.7, 24.5) [315] | 19.7 (15.6, 24.6) [299] | 0.82 |
| 18 mo | 23.4 (19.1, 28.3) [329] | 21.4 (17.2, 26.2) [323] | 18.1 (14.3, 22.7) [320] | 0.25 | 23.3 (19.0, 28.3) [317] | 21.5 (17.4, 26.2) [335] | 18.1 (14.3, 22.7) [320] | 0.26 |
| IDA7 | ||||||||
| 6 mo | 12.0 (8.8, 16.2) [300] | 11.7 (8.6, 15.8) [316] | 12.0 (8.8, 16.2) [299] | 0.99 | 11.6 (8.5, 15.8) [301] | 12.1 (8.9, 16.2) [315] | 12.0 (8.8, 16.2) [299] | 0.98 |
| 18 mo | 4.9 (3.0, 7.8) [329] | 3.4 (1.9, 6.0) [323] | 3.4 (1.9, 6.1) [320] | 0.55 | 4.4 (2.6, 7.3) [317] | 3.9 (2.3, 6.6) [335] | 3.4 (1.9, 6.1) [320] | 0.82 |
All supplements were intended for daily consumption. Results are based on logistic regression models (SAS PROC GLIMMIX). Values are percentages (95% CIs) of participants identified as “yes” for the outcome in question [number of participants analyzed for the outcome in question]. Values in the same row without a common superscript letter are significantly different at α = 0.05. IDA, iron deficiency anemia; IFA, Iron and Folic Acid group: infants were assigned to receive no supplements, their mothers were assigned to receive 60 mg Fe/d and 400 µg folic acid/d during pregnancy and 200 mg Ca/d as placebo during the first 6 mo postpartum; iLiNS, International Lipid-based Nutrient Supplements; LNS, Lipid-based Nutrient Supplement group: infants were assigned to receive 20 g Lipid-based Nutrient Supplement/d (designed for infants) containing 6 mg Fe/d from 6 to 18 mo of age, their mothers received 20 g Lipid-based Nutrient Supplement/d (designed for women) with the same micronutrients as the MMN group during pregnancy and the first 6 mo postpartum—both LNS products contained 4 additional minerals (calcium, phosphorus, potassium, and magnesium) as well as macronutrients; MMN, Multiple Micronutrient group: infants were assigned to receive no supplements, their mothers were assigned to receive a multiple micronutrient capsule containing 18 vitamins and minerals, including 20 mg Fe, daily during pregnancy and the first 6 mo postpartum; ZPP, zinc protoporphyrin.
P values compare all 3 groups, with Tukey–Kramer adjustment for pairwise comparisons.
Anemia defined as blood hemoglobin <110 g/L (33).
Anemia defined as blood hemoglobin <105 g/L for children at 6 mo of age (34), and blood hemoglobin <100 g/L for children at 18 mo of age (31, 34).
Elevated ZPP considered indicative of iron deficiency was defined as ZPP >70 µmol/mol heme. This (moderate) cutoff is consistent with ZPP concentration >10th percentile for preschool children (35–37).