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

NCT02437721 | Completed

• 1 other identifier: 2014-05-06-MTHF
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 2

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.

Conditions

Growth and Development

Outcome Measures

Primary Outcomes (1)

• weight gain (gram/day)

  age of 4 weeks until age of 16 weeks

Secondary Outcomes (5)

• 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

  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)

  during the period age 4 weeks to age 16 weeks

Other Outcomes (31)

• plasma levels of 5-MTHF in infants

  at age of 4 weeks and at the age of 16 weeks

• plasma levels of folic acid in infants

  at age of 4 weeks and at the age of 16 weeks

• plasma levels of 5-Formyl-tetrahydrofolate (fTHF) in infants

  at age of 4 weeks and at the age of 16 weeks

Study Arms (3)

infant formula containing folic acid

ACTIVE COMPARATOR

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

Other: infant formula containing folic acid

infant formula containing MTHF

EXPERIMENTAL

Infant formula including MTHF instead of folic acid

Other: infant formula containing MTHF

Breast milk

NO INTERVENTION

non randomized reference group

Interventions

infant formula containing folic acid OTHER

Also known as: folic acid

infant formula containing folic acid

infant formula containing MTHF OTHER

Also known as: L-5-Methyltetrahydrofolate

infant formula containing MTHF

Eligibility Criteria

• Age: 1 Day - 27 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Serious acquired or congenital diseases that is expected to interfere with normal feeding or growth
• 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

Sponsors & Collaborators

• DSM Nutritional Products, Inc.: lead
• University Clinic Dr Dragisa Misovic-Dedinje: collaborator
• HiPP GmbH & Co. Vertrieb KG: collaborator
• Institute for Laboratory Diagnostics Konzilijum: collaborator
• Bevital AS: collaborator
• Charite University, Berlin, Germany: collaborator
• Sermon CRO: collaborator
• Ludwig-Maximilians - University of Munich: collaborator

Study Sites (2)

KBC Dr Dragiša Mišović-Dedinje

Belgrade, 11000, Serbia

Location

HiPP Clinical Study Center

Belgrade, Serbia

Location

Related Publications (2)

• Obeid R, Warnke I, Wittke A, Bendik I, Troesch B, Schoop R, Hecht C, Demmelmair J, Koletzko B; MEFOLIN Study Group. Infant blood concentrations of folate markers and catabolites are modified by 5,10-methylenetetrahydrofolate reductase C677T genotype and dietary folate source. Am J Clin Nutr. 2023 Mar;117(3):509-517. doi: 10.1016/j.ajcnut.2022.09.002.

  PMID: 36872017 DERIVED

• Troesch B, Demmelmair J, Gimpfl M, Hecht C, Lakovic G, Roehle R, Sipka L, Trisic B, Vusurovic M, Schoop R, Zdjelar S, Koletzko B; MEFOLIN Study Group. Suitability and safety of L-5-methyltetrahydrofolate as a folate source in infant formula: A randomized-controlled trial. PLoS One. 2019 Aug 19;14(8):e0216790. doi: 10.1371/journal.pone.0216790. eCollection 2019.

  PMID: 31425504 DERIVED

MeSH Terms

Interventions

Folic Acid; 5-methyltetrahydrofolate

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Berthold Koletzko, Prof.

  Ludwig-Maximilians - University of Munich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2015
• First Posted: May 8, 2015
• Study Start: May 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: March 1, 2018
• Last Updated: August 10, 2018

Record last verified: 2018-01

Locations

SE (2)