Suitability and safety of L-5-methyltetrahydrofolate as a folate source in infant formula: A randomized-controlled trial.
PLoS One
; 14(8): e0216790, 2019.
Article
em En
| MEDLINE
| ID: mdl-31425504
ABSTRACT
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).
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Tetra-Hidrofolatos
/
Fórmulas Infantis
/
Ácido Fólico
Tipo de estudo:
Clinical_trials
País/Região como assunto:
Europa
Idioma:
En
Revista:
PLoS One
Ano de publicação:
2019
Tipo de documento:
Article
País de afiliação:
Suíça