Suitability of an Infant Formula With L-5-Methyltetrahydrofolate for the Particular Nutritional Use in Infants

Study Overview
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Brief Summary
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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.

Official Title
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Suitability of an Infant Formula With L-5-Methyltetrahydrofolate for the Particular Nutritional Use in Infants

Conditions
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Growth and Development

Intervention / Treatment
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* Other: infant formula containing folic acid
* Other: infant formula containing MTHF


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 27 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: infant formula containing folic acid<br>Infant formula including folic acid within the range stipulated by European legislation on infant formula | Other: infant formula containing folic acid<br> <br> * Other names: folic acid;|
| Experimental: infant formula containing MTHF<br>Infant formula including MTHF instead of folic acid | Other: infant formula containing MTHF<br> <br> * Other names: L-5-Methyltetrahydrofolate;|
| No Intervention: Breast milk<br>non randomized reference group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight gain (gram/day) |  | age of 4 weeks until age of 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |