Table 2.
Primary and secondary maternal efficacy endpoints with significant changes reported from Visit 2 to Visit 4 (per protocol population, LOCF approach).
| Parameters | Placebo (n = 33) | MMS (n = 32) | LS Mean Difference (95% CI) 1 | p Value * |
|---|---|---|---|---|
| Mean ± SD (Range) | ||||
| Milk parameters: | ||||
| DHA (wt % TFA) (primary) | −0.05 ± 0.11 (−0.32 to 0.22) | 0.11 ± 0.12 (−0.23 to 0.32) | 0.15 (0.11–0.19) | <0.0001 |
| EPA, % | −0.01 ± 0.04 (−0.11 to 0.06) | 0.01 ± 0.03 (−0.06 to 0.06) | 0.0110 (0.0006–0.0214) | 0.038 |
| Mead acid, % | 0.019 ± 0.054 (−0.03 to 0.19) | −0.004 ± 0.015 (−0.07 to 0.01) | −0.022 (−0.040 to −0.003) | 0.024 |
| Beta carotene, ng/mL | −5.1 ± 17.2 (−48.0 to 28.0) | 22.7 ± 34.5 (−20.0 to 142.0) | 28.4 (15.0–41.9) | <0.0001 |
| Blood parameters: | ||||
| DHA, mg/L | −9.76 ± 8.98 (−37.0 to 6.9) | 7.14 ± 11.40 (−29.0 to 28.1) | 15.66 (11.96–19.36) | <0.0001 |
| DHA/TFA | −0.004 ± 0.007 (−0.008 to −0.001) | 0.009 ± 0.009 (−0.02 to 0.03) | 0.013 (0.010–0.016) | <0.0001 |
| Docosatetraenoic acid, mg/L | −0.44 ± 1.08 (−3.9 to 1.9) | −0.70 ± 0.87 (−2.2 to 1.8) | −0.46 (−0.86 to −0.05) | 0.0270 |
| EPA, mg/L | −2.84 ± 4.27 (−11.2 to 4.6) | 0.59 ± 4.48 (−10.6 to 13.5) | 2.21 (0.44–3.98) | 0.0155 |
| 25-OH-vitamin D, ng/mL | −1.02 ± 8.18 (−7.5 to 5.50) | 5.88 ± 9.98 (−8.4 to 28.9) | 7.82 (4.36–11.28) | <0.0001 |
| Folic acid, ng/mL | −1.73 ± 4.73 (−11.6 to 16.5) | 17.82 ± 9.51 (11.70−23.80) | 21.20 (17.84–24.56) | <0.0001 |
| Homocysteine, μM | 0.56 ± 1.47 (−3.51 to 3.72) | −1.08 ± 1.24 (−4.24 to 1.71) | −1.63 (−2.27 to −0.99) | <0.0001 |
| Vitamin B12, pg/mL | −17.9 ± 97.0 (−313.0 to 342.0) | 69.0 ± 135.7 (−190.0 to 510.0) | 89.89 (31.45–148.3) | 0.0031 |
| Beta carotene, ng/mL | −49.3 ± 160.3 (−443.0 to 222.0) | 223.3 ± 334.2 (−480.0 to 1182.0) | 296.35 (183.06–409.64) | <0.0001 |
| Lutein, ng/mL | −16.8 ± 33.1 (−91.0 to 40.0) | 5.8 ± 52.2 (−182.0 to 90.0) | 21.13 (4.15–38.31) | 0.0157 |
* p value < 0.05 considered statistically significant. 1 Difference = supplementation – placebo. CI, confidence interval; DHA, docosahexaenoic acid; EPA, eicosapentaenoic acid; LOCF, last observation carried forward; LS mean, least squares mean; MMS, multiple micronutrients, lutein, and DHA supplementation; SD, standard deviation; TFA, total fatty acids; wt, weight.