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

DSM Nutritional Products

Status: Completed

Conditions: Growth and Development

Treatments: Other: infant formula containing folic acid; Other: infant formula containing MTHF

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02437721

2014-05-06-MTHF

Details and patient eligibility

About

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.

Enrollment: 360 patients

Sex: All

Ages: 1 to 27 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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360 participants in 3 patient groups

infant formula containing folic acid

Active Comparator group

Description:

Infant formula including folic acid within the range stipulated by European legislation on infant formula

Treatment:

Other: infant formula containing folic acid

infant formula containing MTHF

Experimental group

Description:

Infant formula including MTHF instead of folic acid

Treatment:

Other: infant formula containing MTHF

Breast milk

No Intervention group

Description:

non randomized reference group