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

August 9, 2018 updated by: DSM Nutritional Products, Inc.
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
360

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Serbia
      • Belgrade, Serbia, 11000
        • KBC Dr Dragiša Mišović-Dedinje
      • Belgrade, Serbia
        • HiPP Clinical Study Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: infant formula containing folic acid
Infant formula including folic acid within the range stipulated by European legislation on infant formula
Other: infant formula containing folic acid
Other Names:
  • folic acid
Experimental: infant formula containing MTHF
Infant formula including MTHF instead of folic acid
Other: infant formula containing MTHF
Other Names:
  • L-5-Methyltetrahydrofolate
No Intervention: Breast milk
non randomized reference group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
weight gain (gram/day)
Time Frame: age of 4 weeks until age of 16 weeks
age of 4 weeks until age of 16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
body length gain (cm/day)
Time Frame: age of 4 weeks until age of 16 weeks
age of 4 weeks until age of 16 weeks
fronto-occipital head circumference gain (in cm/day)
Time Frame: at age of 4 weeks and at the age of 16 weeks
at age of 4 weeks and at the age of 16 weeks
dietary intake of study formula, non-study formula, additional liquids and solids
Time Frame: 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
during the period age 4 weeks to age 16 weeks
feeding related behavior questionnaire
Time Frame: during the period age 4 weeks to age 16 weeks
during the period age 4 weeks to age 16 weeks
stool characteristics (color and consistency)
Time Frame: during the period age 4 weeks to age 16 weeks
stool characteristics are assessed by the Bristol scale criteria
during the period age 4 weeks to age 16 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
plasma levels of 5-MTHF in infants
Time Frame: at age of 4 weeks and at the age of 16 weeks
at age of 4 weeks and at the age of 16 weeks
plasma levels of folic acid in infants
Time Frame: at age of 4 weeks and at the age of 16 weeks
at age of 4 weeks and at the age of 16 weeks
plasma levels of 5-Formyl-tetrahydrofolate (fTHF) in infants
Time Frame: at age of 4 weeks and at the age of 16 weeks
at age of 4 weeks and at the age of 16 weeks
plasma levels of 4-Alfa-hydroxy-5-methyl-THF (hmTHF) in infants
Time Frame: at age of 4 weeks and at the age of 16 weeks
at age of 4 weeks and at the age of 16 weeks
plasma levels of Para-aminobenzoylglutamate (pABG) in infants
Time Frame: at age of 4 weeks and at the age of 16 weeks
at age of 4 weeks and at the age of 16 weeks
plasma levels of Acetamidobenzoylglutamate (apABG) in infants
Time Frame: at age of 4 weeks and at the age of 16 weeks
at age of 4 weeks and at the age of 16 weeks
red cell total folate in infants
Time Frame: at age of 4 weeks and at the age of 16 weeks
at age of 4 weeks and at the age of 16 weeks
plasma levels of 5-MTHF in breast feeding mothers
Time Frame: at the infantile age of 8 weeks
at the infantile age of 8 weeks
breast milk levels of 5-MTHF in breast feeding mothers
Time Frame: at the infantile age of 8 weeks
at the infantile age of 8 weeks
plasma levels of folic acid in breast feeding mothers
Time Frame: at the infantile age of 8 weeks
at the infantile age of 8 weeks
breast milk levels of folic acid in breast feeding mothers
Time Frame: at the infantile age of 8 weeks
at the infantile age of 8 weeks
plasma levels of fTHF in breast feeding mothers
Time Frame: at the infantile age of 8 weeks
at the infantile age of 8 weeks
breast milk levels of fTHF in breast feeding mothers
Time Frame: at the infantile age of 8 weeks
at the infantile age of 8 weeks
plasma levels of hmTHF in breast feeding mothers
Time Frame: at the infantile age of 8 weeks
at the infantile age of 8 weeks
breast milk levels of hmTHF in breast feeding mothers
Time Frame: at the infantile age of 8 weeks
at the infantile age of 8 weeks
plasma levels of pABG in breast feeding mothers
Time Frame: at the infantile age of 8 weeks
at the infantile age of 8 weeks
breast milk levels of pABG in breast feeding mothers
Time Frame: at the infantile age of 8 weeks
at the infantile age of 8 weeks
plasma levels of apABG in breast feeding mothers
Time Frame: at the infantile age of 8 weeks
at the infantile age of 8 weeks
breast milk levels of apABG in breast feeding mothers
Time Frame: at the infantile age of 8 weeks
at the infantile age of 8 weeks
hemoglobin value of the breast feeding mothers
Time Frame: at the infantile age of 8 weeks
at the infantile age of 8 weeks
hematocrit value of the breast feeding mothers
Time Frame: at the infantile age of 8 weeks
at the infantile age of 8 weeks
mean corpuscular volume (MCV) of the breast feeding mothers
Time Frame: at the infantile age of 8 weeks
at the infantile age of 8 weeks
weight of infants
Time Frame: at infantile age 1 year
at infantile age 1 year
length of infants
Time Frame: at infantile age 1 year
at infantile age 1 year
head circumference of infants
Time Frame: at infantile age 1 year
at infantile age 1 year
hemoglobin value of infants
Time Frame: between Day 1 and Day 27 of life, at infantile age of 16 weeks and of 12 months
between Day 1 and Day 27 of life, at infantile age of 16 weeks and of 12 months
hematocrit value of infants
Time Frame: between Day 1 and Day 27 of life, at infantile age of 16 weeks and of 12 months
between Day 1 and Day 27 of life, at infantile age of 16 weeks and of 12 months
mean corpuscular volume (MCV) of infants
Time Frame: between Day 1 and Day 27 of life, at infantile age of 16 weeks and of 12 months
between Day 1 and Day 27 of life, at infantile age of 16 weeks and of 12 months
infantile genotype of methylenetetrahydrofolate-reductase
Time Frame: at infantile age 4 weeks
at infantile age 4 weeks
intake of folic acid in breast feeding mothers
Time Frame: at the infantile age of 8 weeks
at the infantile age of 8 weeks
intake of MTHF in breast feeding mothers
Time Frame: at the infantile age of 8 weeks
at the infantile age of 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
DSM Nutritional Products, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Charite University, Berlin, Germany
Ludwig-Maximilians - University of Munich
HiPP GmbH & Co. Vertrieb KG
University Clinic Dr Dragisa Misovic-Dedinje
Institute for Laboratory Diagnostics Konzilijum
Bevital AS
Sermon CRO

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Berthold Koletzko, Prof., Ludwig-Maximilians - University of Munich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 10, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2014-05-06-MTHF

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