Suitability and safety of L-5-methyltetrahydrofolate as a folate source in infant formula: A randomized-controlled trial

• DOI: 10.1371/journal.pone.0216790
• Publication Date: 2019-08-19T17:25:36Z
• Authors: Barbara Troesch; Johann Demmelmair; Martina Gimpfl; Christina Hecht; Goran Lakovic; Robert Roehle; Ljilja Sipka; Branka Trisic; Milica Vusurovic; Rotraut Schoop; Sznezana Zdjelar; Berthold Koletzko
• Keywords: Male; Genotype; Science; Weight Gain; Polymorphism, Single Nucleotide; 03 medical and health sciences; Folic Acid; 0302 clinical medicine; Double-Blind Method; Germany; Humans; Infant Nutritional Physiological Phenomena; Methylenetetrahydrofolate Reductase (NADPH2); Tetrahydrofolates; Milk, Human; Q; R; Infant, Newborn; Infant; Infant Formula; 3. Good health; Breast Feeding; Medicine; Female; Research Article

L-5-methyltetrahydrofolate is the predominant folate form in human milk but currently not approved as a source for infant and follow-on formula. We aimed to assess suitability of infants. Growth tolerance healthy term infants fed formulae containing equimolar doses (10.4 μg/ 100 ml, n = 120, intervention group) or folic acid (10.0 control was assessed randomized, double-blind, parallel, controlled trial. A reference group breastfed followed. Both were well accepted without differences occurrence adverse events. The most common events cold, poor weight gain growth, rash, eczema, dry skin respiratory tract infection. Weight (the primary outcome) equivalent two groups (95% CI -2.11; 1.68 g/d). In line with this, there only small difference absolute body adjusted birth sex at visit 4 -235; 135 g). Equivalence also shown head circumference recumbent length increase calorie intake. Given nature test, this does indicate an actual difference, means significantly different any these parameters. Infants receiving formula had lower mean plasma levels unmetabolized (intervention: 0.73 nmol/L, control: 1.15 p<0.0001) higher red cell 907.0 ±192.8 839.4 ±142.4 p 0.0095). conclude that suitable use formula, are no indications untoward effects. Trial registration: This trial registered ClinicalTrials.gov (NCT02437721).