TABLE 3.
Outcomes at follow-up and estimated intervention effects for growth, psychomotor development scores, and anemia and iron status indicators for active treatments compared with control1
| SQ-LNS vs. control | SQ-LNS-plus vs. control | ||||||
|---|---|---|---|---|---|---|---|
| SQ-LNS | SQ-LNS-plus | Control | Effect (95% CI) | P | Effect (95% CI) | P | |
| Anthropometric measures2 | |||||||
| Age 8 mo: height, cm | 66.9 ± 2.73 | 67.1 ± 2.6 | 67.3 ± 2.7 | ||||
| LAZ | −1.37 ± 1.12 | −1.37 ± 1.04 | −1.32 ± 1.13 | 0.06 (−0.05, 0.16) | 0.279 | 0.11 (0.01, 0.22) | 0.032 |
| Weight, kg | 7.8 ± 1.2 | 8.0 ± 1.1 | 8.0 ± 1.2 | ||||
| WAZ | −0.68 ± 1.25 | −0.50 ± 1.20 | −0.58 ± 1.27 | 0.01 (−0.07, 0.09) | 0.783 | 0.08 (−0.001, 0.15) | 0.054 |
| Age 10 mo: height, cm | 69.4 ± 3.0 | 69.9 ± 2.5 | 69.9 ± 2.8 | ||||
| LAZ | −1.39 ± 1.20 | −1.34 ± 0.95 | −1.34 ± 1.15 | 0.07 (−0.05, 0.19) | 0.246 | 0.16 (0.04, 0.27) | 0.008 |
| Weight, kg | 8.4 ± 1.2 | 8.7 ± 1.1 | 8.5 ± 1.2 | ||||
| WAZ | −0.57 ± 1.22 | −0.40 ± 1.08 | −0.55 ± 1.22 | 0.07 (−0.04, 0.18) | 0.228 | 0.08 (−0.03, 0.19) | 0.161 |
| Age 12 mo: height, cm | 71.0 ± 2.9 | 71.4 ± 2.6 | 71.5 ± 3.2 | ||||
| LAZ | −1.71 ± 1.18 | −1.71 ± 1.01 | −1.58 ± 1.22 | 0.02 (−0.10, 0.13) | 0.774 | 0.09 (−0.02, 0.21) | 0.115 |
| Weight, kg | 8.7 ± 1.3 | 9.0 ± 1.6 | 8.9 ± 1.3 | ||||
| WAZ | −0.75 ± 1.22 | −0.55 ± 1.12 | −0.61 ± 1.22 | 0.02 (−0.09, 0.12) | 0.764 | 0.05 (−0.06, 0.15) | 0.388 |
| Overall: LAZ | — | — | — | 0.457 | 0.036 | ||
| WAZ | — | — | — | 0.559 | 0.186 | ||
| Midupper arm circumference, cm | 14.5 ± 1.30 | 14.7 ± 1.24 | 14.6 ± 1.31 | −0.02 (−0.09, 0.06) | 0.680 | −0.01 (−0.08, 0.07) | 0.843 |
| Head circumference, cm | 45.1 ± 1.42 | 45.6 ± 1.29 | 45.3 ± 1.46 | −0.03 (−0.09, 0.04) | 0.428 | 0.03 (−0.03, 0.10) | 0.346 |
| Kilifi Developmental Inventory4 | |||||||
| Locomotor development score | 24 (22, 28)5 | 26 (22, 30) | 24 (22, 29) | 0.51 (−1.27, 2.29) | 0.565 | 2.05 (0.72, 3.38) | 0.003 |
| Eye–hand coordination score | 24 (18, 27) | 25 (20, 28) | 24 (19, 27) | 0.32 (−1.47, 2.10) | 0.725 | 1.19 (−0.36, 2.75) | 0.132 |
| Parent rating6 | |||||||
| Adjusted | 33 (30, 36) | 33 (30, 35) | 32 (30, 35) | 0.65 (−0.34, 1.64) | 0.195 | 1.10 (0.14, 2.07) | 0.025 |
| Adjusted and imputed | — | — | — | 0.74 (−0.25, 1.73) | 0.144 | 0.87 (−0.18, 1.91) | 0.102 |
| Time reaching 10th milestone7 | 43.9 | 49.6 | 52.9 | 1.15 (0.88, 1.50) | 0.296 | 1.25 (0.97. 1.62) | 0.079 |
| Hemoglobin and iron status8 | |||||||
| Hemoglobin,9 g/L | 118 (111, 127) | 120 (109, 129) | 115 (106, 125) | 3.94 (0.68, 7.19) | 0.018 | 4.81 (1.40, 8.22) | 0.006 |
| Anemia10 | 23.8 | 25.5 | 34.8 | 0.56 (0.34, 0.92) | 0.021 | 0.61 (0.38, 0.99) | 0.044 |
| Plasma ferritin,11 µg/L | 21.1 (13.7, 32.0) | 23.8 (15.4, 33.1) | 17.3 (9.4, 27.9) | 3.23 (−1.16, 7.61) | 0.149 | 5.37 (1.13, 9.61) | 0.013 |
| Iron deficiency12 | 19.6 | 13.8 | 36.8 | 0.41 (0.22, 0.76) | 0.004 | 0.26 (0.14, 0.50) | <0.001 |
| Iron-deficiency anemia13 | 3.1 | 5.5 | 20.8 | 0.11 (0.03, 0.37) | <0.001 | 0.19 (0.07, 0.48) | 0.001 |
LAZ, length-for-age zscore; SQ-LNS, small-quantity lipid-based nutrient supplement; WAZ, weight-for-age zscore.
Intervention effects were estimated with a mixed-effects (piecewise) linear spline model, fitted via maximum likelihood to all participants in the trial. Infant anthropometric measures of length and weight were taken at bimonthly visits to the study site during the intervention period (6- to 12-mo-old); number of participants seen at specific visits: baseline (n = 750), age 8 mo (n = 535), age 10 mo (n = 443), age 12 mo (n = 514), resulting in 604 (80.5%) participants with ≥1 visit after baseline; the prevalence of stunting at age 12 mo (endpoint) was 41.1% for SQ-LNS, 38.3% for SQ-LNS-plus, and 36.3% for the control group.
Means ± SDs (all such values)
Intervention effects were estimated with imputed quantile regression adjusted for baseline; imputations (n = 10) were carried out using multivariate normal regression analysis with baseline values, sex, age of mother, number of people in the household, LAZ, WAZ, midupper arm circumference, and head circumference at baseline as covariates.
Median; 25th and 75th percentile in parentheses (all such values).
Intervention effects were estimated with quantile regression and imputed quantile regression, both adjusted for baseline measurement.
Values are percentages of participants who had reached the 10th WHO milestone outcome or higher at age 12 mo; intervention effects were estimated using a Cox proportional hazard model, adjusting for baseline LAZ, with participants not reaching this endpoint censored at the age of their last assessment or end of the study.
Intervention effect on hemoglobin concentration was assessed with imputed quantile regression adjusted for baseline values and on plasma ferritin concentration with quantile regression adjusted for baseline hemoglobin. To test the effect of SQ-LNS on the likelihood of anemia, iron deficiency, and iron-deficiency anemia, logistic regression models adjusted for baseline hemoglobin were used.
Baseline (n = 750), age 12 mo (n = 513).
Hemoglobin <110 g/L; values are percentages of participants; intervention effects are ORs (95% CIs), adjusted for baseline hemoglobin.
Adjusted for inflammation considering both C-reactive protein and α1-glycoprotein (43); baseline (n = 480), age 12 mo (n = 350).
Plasma ferritin <12 µg/L; values are percentages of participants; intervention effects are ORs (95% CIs); the prevalence of iron deficiency at age 12 mo (endpoint) was 19.6% for SQ-LNS, 13.8% for SQ-LNS-plus, and 36.8% for the control group.
Hemoglobin <110 g/L and plasma ferritin <12 µg/L; values are percentages of participants; intervention effects are ORs (95% CIs).