Cargando…
Suitability and safety of L-5-methyltetrahydrofolate as a folate source in infant formula: A randomized-controlled trial
L-5-methyltetrahydrofolate is the predominant folate form in human milk but is currently not approved as a folate source for infant and follow-on formula. We aimed to assess the suitability of L-5-methyltetrahydrofolate as a folate source for infants. Growth and tolerance in healthy term infants fed...
Autores principales: | , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Public Library of Science
2019
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6699731/ https://www.ncbi.nlm.nih.gov/pubmed/31425504 http://dx.doi.org/10.1371/journal.pone.0216790 |
_version_ | 1783444766379212800 |
---|---|
author | Troesch, Barbara Demmelmair, Johann Gimpfl, Martina Hecht, Christina Lakovic, Goran Roehle, Robert Sipka, Ljilja Trisic, Branka Vusurovic, Milica Schoop, Rotraut Zdjelar, Sznezana Koletzko, Berthold |
author_facet | Troesch, Barbara Demmelmair, Johann Gimpfl, Martina Hecht, Christina Lakovic, Goran Roehle, Robert Sipka, Ljilja Trisic, Branka Vusurovic, Milica Schoop, Rotraut Zdjelar, Sznezana Koletzko, Berthold |
author_sort | Troesch, Barbara |
collection | PubMed |
description | L-5-methyltetrahydrofolate is the predominant folate form in human milk but is currently not approved as a folate source for infant and follow-on formula. We aimed to assess the suitability of L-5-methyltetrahydrofolate as a folate source for infants. Growth and tolerance in healthy term infants fed formulae containing equimolar doses of L-5-methyltetrahydrofolate (10.4 μg/ 100 ml, n = 120, intervention group) or folic acid (10.0 μg/ 100 ml, n = 120, control group) was assessed in a randomized, double-blind, parallel, controlled trial. A reference group of breastfed infants was followed. Both formulae were well accepted without differences in tolerance or occurrence of adverse events. The most common adverse events were common cold, poor weight gain or growth, rash, eczema, or dry skin and respiratory tract infection. Weight gain (the primary outcome) was equivalent in the two groups (95% CI -2.11; 1.68 g/d). In line with this, there was only a small difference in absolute body weight adjusted for birth weight and sex at visit 4 (95% CI -235; 135 g). Equivalence was also shown for gain in head circumference but not for recumbent length gain and increase in calorie intake. Given the nature of the test, this does not indicate an actual difference, and adjusted means at visit 4 were not significantly different for any of these parameters. Infants receiving formula containing L-5-methyltetrahydrofolate had lower mean plasma levels of unmetabolized folic acid (intervention: 0.73 nmol/L, control: 1.15 nmol/L, p<0.0001) and higher levels of red cell folate (intervention: 907.0 ±192.8 nmol/L, control: 839.4 ±142.4 nmol/L, p = 0.0095). We conclude that L-5-methyltetrahydrofolate is suitable for use in infant and follow-on formula, and there are no indications of untoward effects. Trial registration: This trial was registered at ClinicalTrials.gov (NCT02437721). |
format | Online Article Text |
id | pubmed-6699731 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Public Library of Science |
record_format | MEDLINE/PubMed |
spelling | pubmed-66997312019-09-04 Suitability and safety of L-5-methyltetrahydrofolate as a folate source in infant formula: A randomized-controlled trial Troesch, Barbara Demmelmair, Johann Gimpfl, Martina Hecht, Christina Lakovic, Goran Roehle, Robert Sipka, Ljilja Trisic, Branka Vusurovic, Milica Schoop, Rotraut Zdjelar, Sznezana Koletzko, Berthold PLoS One Research Article L-5-methyltetrahydrofolate is the predominant folate form in human milk but is currently not approved as a folate source for infant and follow-on formula. We aimed to assess the suitability of L-5-methyltetrahydrofolate as a folate source for infants. Growth and tolerance in healthy term infants fed formulae containing equimolar doses of L-5-methyltetrahydrofolate (10.4 μg/ 100 ml, n = 120, intervention group) or folic acid (10.0 μg/ 100 ml, n = 120, control group) was assessed in a randomized, double-blind, parallel, controlled trial. A reference group of breastfed infants was followed. Both formulae were well accepted without differences in tolerance or occurrence of adverse events. The most common adverse events were common cold, poor weight gain or growth, rash, eczema, or dry skin and respiratory tract infection. Weight gain (the primary outcome) was equivalent in the two groups (95% CI -2.11; 1.68 g/d). In line with this, there was only a small difference in absolute body weight adjusted for birth weight and sex at visit 4 (95% CI -235; 135 g). Equivalence was also shown for gain in head circumference but not for recumbent length gain and increase in calorie intake. Given the nature of the test, this does not indicate an actual difference, and adjusted means at visit 4 were not significantly different for any of these parameters. Infants receiving formula containing L-5-methyltetrahydrofolate had lower mean plasma levels of unmetabolized folic acid (intervention: 0.73 nmol/L, control: 1.15 nmol/L, p<0.0001) and higher levels of red cell folate (intervention: 907.0 ±192.8 nmol/L, control: 839.4 ±142.4 nmol/L, p = 0.0095). We conclude that L-5-methyltetrahydrofolate is suitable for use in infant and follow-on formula, and there are no indications of untoward effects. Trial registration: This trial was registered at ClinicalTrials.gov (NCT02437721). Public Library of Science 2019-08-19 /pmc/articles/PMC6699731/ /pubmed/31425504 http://dx.doi.org/10.1371/journal.pone.0216790 Text en © 2019 Troesch et al http://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. |
spellingShingle | Research Article Troesch, Barbara Demmelmair, Johann Gimpfl, Martina Hecht, Christina Lakovic, Goran Roehle, Robert Sipka, Ljilja Trisic, Branka Vusurovic, Milica Schoop, Rotraut Zdjelar, Sznezana Koletzko, Berthold Suitability and safety of L-5-methyltetrahydrofolate as a folate source in infant formula: A randomized-controlled trial |
title | Suitability and safety of L-5-methyltetrahydrofolate as a folate source in infant formula: A randomized-controlled trial |
title_full | Suitability and safety of L-5-methyltetrahydrofolate as a folate source in infant formula: A randomized-controlled trial |
title_fullStr | Suitability and safety of L-5-methyltetrahydrofolate as a folate source in infant formula: A randomized-controlled trial |
title_full_unstemmed | Suitability and safety of L-5-methyltetrahydrofolate as a folate source in infant formula: A randomized-controlled trial |
title_short | Suitability and safety of L-5-methyltetrahydrofolate as a folate source in infant formula: A randomized-controlled trial |
title_sort | suitability and safety of l-5-methyltetrahydrofolate as a folate source in infant formula: a randomized-controlled trial |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6699731/ https://www.ncbi.nlm.nih.gov/pubmed/31425504 http://dx.doi.org/10.1371/journal.pone.0216790 |
work_keys_str_mv | AT troeschbarbara suitabilityandsafetyofl5methyltetrahydrofolateasafolatesourceininfantformulaarandomizedcontrolledtrial AT demmelmairjohann suitabilityandsafetyofl5methyltetrahydrofolateasafolatesourceininfantformulaarandomizedcontrolledtrial AT gimpflmartina suitabilityandsafetyofl5methyltetrahydrofolateasafolatesourceininfantformulaarandomizedcontrolledtrial AT hechtchristina suitabilityandsafetyofl5methyltetrahydrofolateasafolatesourceininfantformulaarandomizedcontrolledtrial AT lakovicgoran suitabilityandsafetyofl5methyltetrahydrofolateasafolatesourceininfantformulaarandomizedcontrolledtrial AT roehlerobert suitabilityandsafetyofl5methyltetrahydrofolateasafolatesourceininfantformulaarandomizedcontrolledtrial AT sipkaljilja suitabilityandsafetyofl5methyltetrahydrofolateasafolatesourceininfantformulaarandomizedcontrolledtrial AT trisicbranka suitabilityandsafetyofl5methyltetrahydrofolateasafolatesourceininfantformulaarandomizedcontrolledtrial AT vusurovicmilica suitabilityandsafetyofl5methyltetrahydrofolateasafolatesourceininfantformulaarandomizedcontrolledtrial AT schooprotraut suitabilityandsafetyofl5methyltetrahydrofolateasafolatesourceininfantformulaarandomizedcontrolledtrial AT zdjelarsznezana suitabilityandsafetyofl5methyltetrahydrofolateasafolatesourceininfantformulaarandomizedcontrolledtrial AT koletzkoberthold suitabilityandsafetyofl5methyltetrahydrofolateasafolatesourceininfantformulaarandomizedcontrolledtrial AT suitabilityandsafetyofl5methyltetrahydrofolateasafolatesourceininfantformulaarandomizedcontrolledtrial |