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

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.

Conditions

• Growth and Development

Interventions

OTHER

infant formula containing folic acid

OTHER

infant formula containing MTHF

Sponsors & Collaborators

• University Clinic Dr Dragisa Misovic-Dedinje

  collaborator OTHER

• HiPP GmbH & Co. Vertrieb KG

  collaborator INDUSTRY

• Institute for Laboratory Diagnostics Konzilijum

  collaborator UNKNOWN

• Bevital AS

  collaborator UNKNOWN

• Charite University, Berlin, Germany

  collaborator OTHER

• Sermon CRO

  collaborator INDUSTRY

• Ludwig-Maximilians - University of Munich

  collaborator OTHER

• DSM Nutritional Products, Inc.

  lead INDUSTRY

Principal Investigators

• Berthold Koletzko, Prof. · Ludwig-Maximilians - University of Munich

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

1 Day

Max Age

27 Days

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-05-31

Primary Completion

2017-08-31

Completion

2018-03-31

Countries

• Serbia

Study Locations