Multiple Micronutrients, Lutein, and Docosahexaenoic Acid Supplementation during Lactation: A Randomized Controlled Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Trial Design
2.2. Study Population
2.3. Randomization to Study Product
2.4. Parameters Assessed
Biochemical Analyses
2.5. Power Calculation and Statistical Analyses
3. Results
3.1. Subject Characteristics
3.2. Efficacy Endpoints
3.2.1. Primary Endpoint
3.2.2. Secondary Maternal Endpoints
3.2.3. Exploratory Infant Endpoints
3.2.4. Safety Analysis
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Acknowledgments
Conflicts of Interest
References
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Characteristics | Placebo (n = 33) | MMS (n = 32) | Total (n = 65) |
---|---|---|---|
Age, years | 31.7 ± 4.0 (21–38) | 31.7 ± 3.5 (25–39) | 31.7 ± 3.8 (21–39) |
Race: | |||
Caucasian | 33 (100.0) | 28 (87.5) | 61 (93.8) |
Black/African American | 0 | 1 (3.1) | 1 (1.5) |
Asian | 0 | 2 (6.3) | 2 (3.1) |
Other | 0 | 1 (3.1) | 1 (1.5) |
Weight, kg | 70.8 ± 10.29 (52.0–110.0) | 69.3 ± 13.30 (52.2–107.0) | 70.1 ± 11.80 (52.0–110.0) |
Height, cm | 1.67 ± 0.08 (1.48–1.90) | 1.68 ± 0.06 (1.53–1.83) | 1.67 ± 0.07 (1.48–1.90) |
Body mass index, kg/m2 | 25.29 ± 3.62 (19.8–38.1) | 24.6 ± 3.97 (19.3–32.4) | 25.0 ± 3.78 (19.3–38.1) |
Gestational age, weeks: 1 | |||
Early term | 6 (18.2) | 5 (15.6) | 11 (16.9) |
Full term | 24 (72.7) | 21 (65.6) | 45 (69.2) |
Late term | 3 (9.1) | 6 (18.8) | 9 (13.8) |
Delivery type: | |||
Vaginal | 27 (81.8) | 24 (75.0) | 51 (78.5) |
Caesarean | 6 (18.2) | 8 (25.0) | 14 (21.5) |
Delivery complications, Yes | 1 (3.0) | 5 (15.6) | 6 (9.2) |
Infant birth weight, g | 3400.6 ± 355.6 (2860–4130) | 3556.9 ± 347.5 (2856–4375) | 3477.6 ± 357.7 (2856–4375) |
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 |
Parameters | Placebo (n = 35) | MMS (n = 35) |
---|---|---|
Mothers with at least one AE, n | 19 | 18 |
Mothers with at least one AE: 1 | ||
Mild | 11 (57.9) | 10 (55.6) |
Moderate | 7 (36.8) | 8 (44.4) |
Severe | 1 (5.3) | 0 |
Mothers with at least one SAE | 0 | 3 (16.7) |
Mothers with at least one treatment-related AE 2 | 1 (5.3) | 1 (5.6) |
Number of infant AEs, n | 9 | 7 |
Infants with at least one AE: 1 | ||
Mild | 2 (28.6) | 6 (66.7) |
Moderate | 4 (57.1) | 3 (33.3) |
Severe | 1 (14.3) | 0 |
Infants with at least one SAE | 4 (57.1) | 2 (22.2) |
Infants with at least one treatment-related AE | 0 | 0 |
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Schaefer, E.; Demmelmair, H.; Horak, J.; Holdt, L.; Grote, V.; Maar, K.; Neuhofer, C.; Teupser, D.; Thiel, N.; Goeckeler-Leopold, E.; et al. Multiple Micronutrients, Lutein, and Docosahexaenoic Acid Supplementation during Lactation: A Randomized Controlled Trial. Nutrients 2020, 12, 3849. https://doi.org/10.3390/nu12123849
Schaefer E, Demmelmair H, Horak J, Holdt L, Grote V, Maar K, Neuhofer C, Teupser D, Thiel N, Goeckeler-Leopold E, et al. Multiple Micronutrients, Lutein, and Docosahexaenoic Acid Supplementation during Lactation: A Randomized Controlled Trial. Nutrients. 2020; 12(12):3849. https://doi.org/10.3390/nu12123849
Chicago/Turabian StyleSchaefer, Ella, Hans Demmelmair, Jeannie Horak, Lesca Holdt, Veit Grote, Karoline Maar, Christoph Neuhofer, Daniel Teupser, Nadja Thiel, Erwin Goeckeler-Leopold, and et al. 2020. "Multiple Micronutrients, Lutein, and Docosahexaenoic Acid Supplementation during Lactation: A Randomized Controlled Trial" Nutrients 12, no. 12: 3849. https://doi.org/10.3390/nu12123849