TABLE 3.
Outcomes at 5–10 y according to allocation group1
| Intention-to-treat sample (all children studied, maximum n = 1255) | Per protocol sample (children of mothers who started supplementation ≥3 mo before conception, maximum n = 1016) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Control group | Intervention group | Control group | Intervention group | |||||||||
| Outcome | n | n | P 1 | P 2 | n | n | P 1 | P 2 | ||||
| Anthropometry | ||||||||||||
| Height z-score | 649 | –1.0 ± 1.0 | 605 | –1.0 ± 1.0 | 0.78 | 0.72 | 534 | –1.0 ± 1.0 | 481 | –1.0 ± 1.0 | 0.91 | 0.88 |
| Stunted, n (%) | 649 | 97 (15.0) | 605 | 97 (16.0) | 0.60 | — | 534 | 85 (15.9) | 481 | 74 (15.4) | 0.82 | — |
| BMI z-score | 649 | –1.6 ± 1.1 | 605 | –1.5 ± 1.2 | 0.45 | 0.16 | 534 | –1.6 ± 1.1 | 481 | –1.5 ± 1.2 | 0.23 | 0.04 |
| BMI categories,3n (%) | ||||||||||||
| Wasting | 649 | 224 (34.5) | 605 | 203 (33.6) | 0.72 | — | 534 | 190 (35.6) | 481 | 160 (33.3) | 0.44 | — |
| Normal BMI | 649 | 411 (63.3) | 605 | 380 (62.8) | 0.85 | — | 534 | 332 (62.2) | 481 | 304 (63.2) | 0.74 | — |
| Overweight/obese | 649 | 14 (2.2) | 605 | 22 (3.6) | 0.12 | — | 534 | 12 (2.3) | 481 | 17 (3.5) | 0.22 | — |
| Sum of skinfolds,4 mm | 649 | 21.9 (19.1, 24.9) | 605 | 22.0 (19.1, 25.5) | 0.36 | 0.18 | 534 | 21.7 (19.0, 24.8) | 481 | 21.8 (19.0, 25.4) | 0.36 | 0.02 |
| Grip strength, kg | 648 | 6.7 ± 1.6 | 605 | 6.6 ± 1.5 | 0.63 | 0.88 | 533 | 6.7 ± 1.6 | 481 | 6.6 ± 1.5 | 0.87 | 0.88 |
| Body composition (DXA) | ||||||||||||
| Fat mass,4 kg | 637 | 2.4 (1.9, 3.1) | 590 | 2.5 (1.9, 3.1) | 0.40 | 0.06 | 525 | 2.3 (1.9, 3.0) | 470 | 2.5 (1.9, 3.1) | 0.31 | 0.01 |
| Lean mass, kg | 637 | 13.0 ± 1.5 | 590 | 13.0 ± 1.5 | 0.97 | 0.72 | 525 | 13.0 ± 1.5 | 470 | 13.0 ± 1.5 | 0.62 | 0.53 |
| Percent fat,4 % | 637 | 14.8 (12.0, 18.0) | 590 | 15.0 (12.3, 18.2) | 0.40 | 0.08 | 525 | 14.7 (11.9, 17.9) | 470 | 14.9 (12.3, 18.0) | 0.39 | 0.02 |
| Cardiometabolic risk markers | ||||||||||||
| Systolic BP, mmHg | 641 | 92.9 ± 8.4 | 602 | 92.8 ± 8.9 | 0.75 | 0.34 | 526 | 92.9 ± 8.5 | 479 | 93.1 ± 8.8 | 0.75 | 0.14 |
| Diastolic BP, mmHg | 641 | 56.2 ± 7.3 | 602 | 56.6 ± 7.4 | 0.28 | 0.60 | 526 | 56.1 ± 7.3 | 479 | 56.8 ± 7.5 | 0.14 | 0.28 |
| Pulse rate, beats/min | 646 | 97.7 ± 11.5 | 604 | 96.3 ± 11.3 | 0.03 | 0.46 | 531 | 98.1 ± 11.2 | 480 | 96.2 ± 11.5 | 0.01 | 0.44 |
| LDL cholesterol, mmol/L | 627 | 2.38 ± 0.65 | 583 | 2.31 ± 0.61 | 0.05 | 0.18 | 515 | 2.39 ± 0.63 | 464 | 2.32 ± 0.59 | 0.07 | 0.29 |
| HDL cholesterol, mmol/L | 627 | 1.07 ± 0.23 | 584 | 1.07 ± 0.22 | 0.69 | 0.14 | 515 | 1.07 ± 0.23 | 465 | 1.07 ± 0.23 | 0.71 | 0.14 |
| Triglycerides,4 mmol/L | 627 | 0.85 (0.68, 1.05) | 584 | 0.84 (0.70, 1.07) | 0.98 | 0.89 | 515 | 0.85 (0.69, 1.05) | 465 | 0.84 (0.70, 1.07) | 0.69 | 0.49 |
| Fasting glucose, mmol/L | 640 | 4.68 ± 0.52 | 592 | 4.67 ± 0.58 | 0.54 | 0.85 | 526 | 4.69 ± 0.52 | 472 | 4.69 ± 0.55 | 0.91 | 0.74 |
| 120-min glucose, mmol/L | 610 | 4.66 ± 0.88 | 573 | 4.65 ± 1.04 | 0.89 | 0.74 | 500 | 4.65 ± 0.87 | 455 | 4.67 ± 0.92 | 0.82 | 0.65 |
| HOMA-S4 | 619 | 223 (142, 387) | 577 | 223 (137, 376) | 0.56 | 0.71 | 507 | 225 (148, 403) | 458 | 228 (137, 367) | 0.45 | 0.74 |
| Insulogenic index | 614 | 1.63 ± 1.11 | 570 | 1.50 ± 1.16 | 0.06 | 0.66 | 507 | 1.66 ± 1.13 | 452 | 1.53 ±1.17 | 0.08 | 0.99 |
| Disposition index | 606 | 7.0 ± 1.7 | 564 | 6.9 ± 1.7 | 0.17 | 0.82 | 499 | 7.0 ± 1.7 | 446 | 6.9 ± 1.7 | 0.19 | 0.96 |
1
,2Values are mean ± SD unless otherwise specified. All body composition and cardiometabolic outcomes were adjusted for the child's age and sex except for Z-scores. P1: significance of difference between control and intervention groups; P2: significance of interaction between allocation group and sex. BP: blood pressure; HOMA-S: insulin sensitivity by Homeostasis Model Assessment.
3
Categorical variables are expressed as number (n) and (%).
4
Skewed variables are expressed as median and (IQR).