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| Name | Class |
|---|---|
| University Clinic Dr Dragisa Misovic-Dedinje | OTHER |
| HiPP GmbH & Co. Vertrieb KG | INDUSTRY |
| Institute for Laboratory Diagnostics Konzilijum | UNKNOWN |
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The study is designed to show equivalence of an infant formula containing L-5- Methyltetrahydrofolate (MTHF) compared to a standard infant formula containing folic acid in respect to weight gain of healthy term infants receiving these infant formulae exclusively during the first 4 months of life. Healthy non breast fed infants will be randomized to receive either a standard infant formula with folic acid or a corresponding formula with MTHF instead of folic acid. Besides weight and length further anthropometric measures will be taken monthly from the age of 4 weeks to the age of 16 weeks and at the age 4 and 16 weeks blood samples will be taken for the determination of folate status and genotyping. As a reference the same measures will be taken in a group of breast fed infants, whose mothers' folate status will be determined as well.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| infant formula containing folic acid | Active Comparator | Infant formula including folic acid within the range stipulated by European legislation on infant formula |
|
| infant formula containing MTHF | Experimental | Infant formula including MTHF instead of folic acid |
|
| Breast milk | No Intervention | non randomized reference group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| infant formula containing folic acid | Other |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| weight gain (gram/day) | age of 4 weeks until age of 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| body length gain (cm/day) | age of 4 weeks until age of 16 weeks | |
| fronto-occipital head circumference gain (in cm/day) | at age of 4 weeks and at the age of 16 weeks | |
| Measure | Description | Time Frame |
|---|---|---|
| plasma levels of 5-MTHF in infants | at age of 4 weeks and at the age of 16 weeks | |
| plasma levels of folic acid in infants | at age of 4 weeks and at the age of 16 weeks | |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Berthold Koletzko, Prof. | Ludwig-Maximilians - University of Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KBC Dr Dragiša Mišović-Dedinje | Belgrade | 11000 | Serbia | |||
| HiPP Clinical Study Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36872017 | Derived | Obeid R, Warnke I, Wittke A, Bendik I, Troesch B, Schoop R, Hecht C, Demmelmair J, Koletzko B; MEFOLIN Study Group. Infant blood concentrations of folate markers and catabolites are modified by 5,10-methylenetetrahydrofolate reductase C677T genotype and dietary folate source. Am J Clin Nutr. 2023 Mar;117(3):509-517. doi: 10.1016/j.ajcnut.2022.09.002. | |
| 31425504 |
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| ID | Term |
|---|---|
| D005492 | Folic Acid |
| C005984 | 5-methyltetrahydrofolate |
| ID | Term |
|---|---|
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Bevital AS |
| UNKNOWN |
| Charite University, Berlin, Germany | OTHER |
| Sermon CRO | INDUSTRY |
| Ludwig-Maximilians - University of Munich | OTHER |
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| infant formula containing MTHF |
| Other |
|
|
| dietary intake of study formula, non-study formula, additional liquids and solids |
dietary intake will be determined as kcal per day and as kcal per kg body weight per day |
| during the period age 4 weeks to age 16 weeks |
| feeding related behavior questionnaire | during the period age 4 weeks to age 16 weeks |
| stool characteristics (color and consistency) | stool characteristics are assessed by the Bristol scale criteria | during the period age 4 weeks to age 16 weeks |
| plasma levels of 5-Formyl-tetrahydrofolate (fTHF) in infants |
| at age of 4 weeks and at the age of 16 weeks |
| plasma levels of 4-Alfa-hydroxy-5-methyl-THF (hmTHF) in infants | at age of 4 weeks and at the age of 16 weeks |
| plasma levels of Para-aminobenzoylglutamate (pABG) in infants | at age of 4 weeks and at the age of 16 weeks |
| plasma levels of Acetamidobenzoylglutamate (apABG) in infants | at age of 4 weeks and at the age of 16 weeks |
| red cell total folate in infants | at age of 4 weeks and at the age of 16 weeks |
| plasma levels of 5-MTHF in breast feeding mothers | at the infantile age of 8 weeks |
| breast milk levels of 5-MTHF in breast feeding mothers | at the infantile age of 8 weeks |
| plasma levels of folic acid in breast feeding mothers | at the infantile age of 8 weeks |
| breast milk levels of folic acid in breast feeding mothers | at the infantile age of 8 weeks |
| plasma levels of fTHF in breast feeding mothers | at the infantile age of 8 weeks |
| breast milk levels of fTHF in breast feeding mothers | at the infantile age of 8 weeks |
| plasma levels of hmTHF in breast feeding mothers | at the infantile age of 8 weeks |
| breast milk levels of hmTHF in breast feeding mothers | at the infantile age of 8 weeks |
| plasma levels of pABG in breast feeding mothers | at the infantile age of 8 weeks |
| breast milk levels of pABG in breast feeding mothers | at the infantile age of 8 weeks |
| plasma levels of apABG in breast feeding mothers | at the infantile age of 8 weeks |
| breast milk levels of apABG in breast feeding mothers | at the infantile age of 8 weeks |
| hemoglobin value of the breast feeding mothers | at the infantile age of 8 weeks |
| hematocrit value of the breast feeding mothers | at the infantile age of 8 weeks |
| mean corpuscular volume (MCV) of the breast feeding mothers | at the infantile age of 8 weeks |
| weight of infants | at infantile age 1 year |
| length of infants | at infantile age 1 year |
| head circumference of infants | at infantile age 1 year |
| hemoglobin value of infants | between Day 1 and Day 27 of life, at infantile age of 16 weeks and of 12 months |
| hematocrit value of infants | between Day 1 and Day 27 of life, at infantile age of 16 weeks and of 12 months |
| mean corpuscular volume (MCV) of infants | between Day 1 and Day 27 of life, at infantile age of 16 weeks and of 12 months |
| infantile genotype of methylenetetrahydrofolate-reductase | at infantile age 4 weeks |
| intake of folic acid in breast feeding mothers | at the infantile age of 8 weeks |
| intake of MTHF in breast feeding mothers | at the infantile age of 8 weeks |
| Belgrade |
| Serbia |
| Troesch B, Demmelmair J, Gimpfl M, Hecht C, Lakovic G, Roehle R, Sipka L, Trisic B, Vusurovic M, Schoop R, Zdjelar S, Koletzko B; MEFOLIN Study Group. Suitability and safety of L-5-methyltetrahydrofolate as a folate source in infant formula: A randomized-controlled trial. PLoS One. 2019 Aug 19;14(8):e0216790. doi: 10.1371/journal.pone.0216790. eCollection 2019. |
| D006571 | Heterocyclic Compounds |