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Randomized Controlled Trial
. 2020 Dec 16;12(12):3849.
doi: 10.3390/nu12123849.

Multiple Micronutrients, Lutein, and Docosahexaenoic Acid Supplementation during Lactation: A Randomized Controlled Trial

Ella Schaefer  1 , Hans Demmelmair  2 , Jeannie Horak  2 , Lesca Holdt  3 , Veit Grote  2 , Karoline Maar  4 , Christoph Neuhofer  5 , Daniel Teupser  3 , Nadja Thiel  5 , Erwin Goeckeler-Leopold  6 , Silvia Maggini  1 , Berthold Koletzko  2
Affiliations
Randomized Controlled Trial

Multiple Micronutrients, Lutein, and Docosahexaenoic Acid Supplementation during Lactation: A Randomized Controlled Trial

Ella Schaefer et al. Nutrients. .

Abstract

Breastfed infants require an adequate supply of critical nutrients for growth, tissue functions, and health. Recommended intakes for several nutrients are considerably higher in lactating than non-lactating women but are not always met with habitual diets. We report a randomized, double-blind clinical trial in 70 healthy lactating women in Germany evaluating the effects of supplementation with multiple micronutrients, lutein, and docosahexaenoic acid (DHA) compared to placebo on maternal nutrient status and milk composition. The primary endpoint was the effect on the change of human milk DHA content (as a proportion of total milk fatty acids) during 12 weeks of supplementation. Maternal blood and milk biomarkers were measured as secondary endpoints. Supplementation increased maternal milk DHA by 30% compared to a decline in the placebo group. Supplementation also increased maternal blood DHA (17%), eicosapentaenoic acid (4%), 25-OH-vitamin D (24%), vitamin B12 (12%), lutein (4%), and beta carotene (49%), while homocysteine decreased. No significant difference in the number of adverse events was observed between supplementation and placebo groups. In conclusion, multi-micronutrient supplementation was safe and increased maternal blood and milk concentrations of selected nutrients in healthy women.

Keywords: docosahexaenoic acid; lactation; lutein; maternal biomarkers; micronutrients.

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Conflict of interest statement

S.M. and E.S. are employed by Bayer Consumer Care AG, who sponsored the clinical study. K.M., C.N., N.T., and E.G.-L. were investigators of the clinical study and received remuneration from Bayer Consumer Care AG for their services related to the study. LMU–University of Munich and its employees B.K., H.D., J.H., V.G., D.T., and L.H. analyzed samples from the study and received remuneration from Bayer Consumer Care AG for their services related to the clinical study. Further, H.D., V.G., J.H., and B.K. benefitted from financial support from the European Commission, H2020 Programs DYNAHEALTH-633595 und Lifecycle-733206, the European Research Council Advanced Grant META-GROWTH ERC-2012-AdG–no.322605, the Erasmus Plus Programs Early Nutrition eAcademy Southeast Asia-573651-EPP-1-2016-1-DE-EPPKA2-CBHE-JP, and Capacity Building to Improve Early Nutrition and Health in South Africa-598488-EPP-1-2018-1-DE-EPPKA2-CBHE-JP, the EU Interreg Program Focus in CD-CE111 and the European Joint Programming Initiative Projects NutriPROGRAM and EndObesity, the German Ministry of Education and Research, Berlin (Grant Nr. 01 GI 0825), and the German Research Council (Ko912/12-1 and INST 409/224-1 FUGG). B.K. is the Else Kröner-Senior Professor of Pediatrics at LMU, financially supported by the Else Kröner-Fresenius-Foundation and LMU University Hospitals.

Figures

Figure 1
Figure 1
Study design. V1a, first screening; V1b, second screening; V2, randomization and baseline; V3, milk and blood sampling in mothers and measurement of infant anthropometric parameters; V4 (end of study). Phone calls to lactating women carried out between V2 and V4, final follow-up call after V4. FU, follow-up; GA, gestational age; MMS, multiple micronutrients, lutein, and docosahexaenoic acid supplementation; PC, phone call; V, visit; wks, weeks.
Figure 2
Figure 2
Flow diagram for study participants. ITT, intention-to-treat; MMS, multiple micronutrients, lutein, and docosahexaenoic acid (DHA) supplementation.
See this image and copyright information in PMC

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