Growth and Development
Conditions
Brief summary
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.
Interventions
OTHERinfant formula containing folic acid
OTHERinfant formula containing MTHF
Sponsors
University Clinic Dr Dragisa Misovic-Dedinje
HiPP GmbH & Co. Vertrieb KG
Institute for Laboratory Diagnostics Konzilijum
Bevital AS
Charite University, Berlin, Germany
Sermon CRO
Ludwig-Maximilians - University of Munich
DSM Nutritional Products, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 27 Days
Healthy volunteers
Yes
Inclusion criteria
* Written informed consent (by parents, caregiver) * Healthy male or female infants \<28 days of life * Gestational age at delivery ≥37 and ≤42 weeks * Birth weight between 2500 - 4500g * Parents / Caregivers are able to speak Serbian language
Exclusion criteria
* Serious acquired or congenital diseases that is expected to interfere with normal feeding or growth * Feeding of more than 10% of energy (1 bottle/day) from sources other than the formula (or breast milk in the reference group) at inclusion * Participation in another clinical study * Mothers with diabetes mellitus (including gestational diabetes) * Reason to presume that the parents are unable to meet the study plan requirements * Diseases of the mother which have an effect on the child's gastro-intestinal tract/ability to be fed * Major abnormalities in hematological parameters * Major abnormalities in hepatic, renal or metabolic functions * Use of medication and vitamin supplements except vitamin K or D supplementation or vaccination * Mother follows a vegan diet
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| weight gain (gram/day) | age of 4 weeks until age of 16 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| dietary intake of study formula, non-study formula, additional liquids and solids | during the period age 4 weeks to age 16 weeks | dietary intake will be determined as kcal per day and as kcal per kg body weight per day |
| feeding related behavior questionnaire | during the period age 4 weeks to age 16 weeks | — |
| stool characteristics (color and consistency) | during the period age 4 weeks to age 16 weeks | stool characteristics are assessed by the Bristol scale criteria |
Other
| Measure | Time frame |
|---|---|
| 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 |
| plasma levels of 5-MTHF in infants | at age of 4 weeks and at the age of 16 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 |
| breast milk levels of apABG in breast feeding mothers | at the infantile age of 8 weeks |
| plasma levels of folic acid in infants | at age of 4 weeks and at the age of 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 |
Countries
Serbia
Outcome results
None listed