Suitability of an Infant Formula With L-5-Methyltetrahydrofolate for the Particular Nutritional Use in Infants
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 360
- Locations
- 3
- Primary Endpoint
- weight gain (gram/day)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Day to 27 Days (Child)
- Sex
- All
- Accepts 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
Arms & Interventions
infant formula containing folic acid
Infant formula including folic acid within the range stipulated by European legislation on infant formula
Intervention: infant formula containing folic acid (Other)
infant formula containing MTHF
Infant formula including MTHF instead of folic acid
Intervention: infant formula containing MTHF (Other)
Breast milk
non randomized reference group
Outcomes
Primary Outcomes
weight gain (gram/day)
Time Frame: age of 4 weeks until age of 16 weeks
Secondary Outcomes
- dietary intake of study formula, non-study formula, additional liquids and solids(during the period age 4 weeks to age 16 weeks)
- feeding related behavior questionnaire(during the period age 4 weeks to age 16 weeks)
- 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)
- stool characteristics (color and consistency)(during the period age 4 weeks to age 16 weeks)