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Completed

NCT Number: NCT02437721

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

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.

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Key information

Conditions

Growth and Development

Age range

1 day–27 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HiPP Clinical Study Center, Belgrade, Serbia

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

infant formula containing folic acid

Other

Other names: folic acid

infant formula containing MTHF

Other

Other names: L-5-Methyltetrahydrofolate

Primary outcomes

  1. weight gain (gram/day)

    Time frame: age of 4 weeks until age of 16 weeks

Secondary outcomes

  1. body length gain (cm/day)

    Time frame: age of 4 weeks until age of 16 weeks

  2. fronto-occipital head circumference gain (in cm/day)

    Time frame: at age of 4 weeks and at the age of 16 weeks

  3. 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

  4. feeding related behavior questionnaire

    Time frame: during the period age 4 weeks to age 16 weeks

  5. 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

Other outcomes

  1. plasma levels of 5-MTHF in infants

    Time frame: at age of 4 weeks and at the age of 16 weeks

  2. plasma levels of folic acid in infants

    Time frame: at age of 4 weeks and at the age of 16 weeks

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

    Time frame: at age of 4 weeks and at the age of 16 weeks

  4. 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

  5. plasma levels of Para-aminobenzoylglutamate (pABG) in infants

    Time frame: at age of 4 weeks and at the age of 16 weeks

  6. plasma levels of Acetamidobenzoylglutamate (apABG) in infants

    Time frame: at age of 4 weeks and at the age of 16 weeks

  7. red cell total folate in infants

    Time frame: at age of 4 weeks and at the age of 16 weeks

  8. plasma levels of 5-MTHF in breast feeding mothers

    Time frame: at the infantile age of 8 weeks

  9. breast milk levels of 5-MTHF in breast feeding mothers

    Time frame: at the infantile age of 8 weeks

  10. plasma levels of folic acid in breast feeding mothers

    Time frame: at the infantile age of 8 weeks

  11. breast milk levels of folic acid in breast feeding mothers

    Time frame: at the infantile age of 8 weeks

  12. plasma levels of fTHF in breast feeding mothers

    Time frame: at the infantile age of 8 weeks

  13. breast milk levels of fTHF in breast feeding mothers

    Time frame: at the infantile age of 8 weeks

  14. plasma levels of hmTHF in breast feeding mothers

    Time frame: at the infantile age of 8 weeks

  15. breast milk levels of hmTHF in breast feeding mothers

    Time frame: at the infantile age of 8 weeks

  16. plasma levels of pABG in breast feeding mothers

    Time frame: at the infantile age of 8 weeks

  17. breast milk levels of pABG in breast feeding mothers

    Time frame: at the infantile age of 8 weeks

  18. plasma levels of apABG in breast feeding mothers

    Time frame: at the infantile age of 8 weeks

  19. breast milk levels of apABG in breast feeding mothers

    Time frame: at the infantile age of 8 weeks

  20. hemoglobin value of the breast feeding mothers

    Time frame: at the infantile age of 8 weeks

  21. hematocrit value of the breast feeding mothers

    Time frame: at the infantile age of 8 weeks

  22. mean corpuscular volume (MCV) of the breast feeding mothers

    Time frame: at the infantile age of 8 weeks

  23. weight of infants

    Time frame: at infantile age 1 year

  24. length of infants

    Time frame: at infantile age 1 year

  25. head circumference of infants

    Time frame: at infantile age 1 year

  26. hemoglobin value of infants

    Time frame: between Day 1 and Day 27 of life, at infantile age of 16 weeks and of 12 months

  27. hematocrit value of infants

    Time frame: between Day 1 and Day 27 of life, at infantile age of 16 weeks and of 12 months

  28. 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

  29. infantile genotype of methylenetetrahydrofolate-reductase

    Time frame: at infantile age 4 weeks

  30. intake of folic acid in breast feeding mothers

    Time frame: at the infantile age of 8 weeks

  31. intake of MTHF in breast feeding mothers

    Time frame: at the infantile age of 8 weeks

Sponsors and collaborators

Lead sponsor

dsm-firmenich Switzerland AG

Industry

Collaborators

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

Registry information

Acronym: MEFOLIN

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
May 8, 2015
Registry last updated
Aug 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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