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

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ClinicalTrials.gov Identifier: NCT02437721
Recruitment Status : Active, not recruiting
First Posted : May 8, 2015
Last Update Posted : January 23, 2018
Sponsor:
Collaborators:
KBC Dr Dragisa Misovic-Dedinje
HiPP GmbH & Co. Vertrieb KG
Institute for Laboratory Diagnostics Konzilijum
Bevital AS
Charite University, Berlin, Germany
Sermon CRO
Ludwig-Maximilians - University of Munich
Information provided by (Responsible Party):
DSM Nutritional Products, Inc.

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.

Condition or disease Intervention/treatment Phase
Growth and Development Other: infant formula containing folic acid Other: infant formula containing MTHF Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Suitability of an Infant Formula With L-5-Methyltetrahydrofolate for the Particular Nutritional Use in Infants
Study Start Date : May 2015
Actual Primary Completion Date : August 2017
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: folic acid

Experimental: infant formula containing MTHF
Infant formula including MTHF instead of folic acid
Other: infant formula containing MTHF
Other Name: L-5-Methyltetrahydrofolate

No Intervention: Breast milk
non randomized reference group



Primary Outcome Measures :
  1. weight gain (gram/day) [ Time Frame: age of 4 weeks until age of 16 weeks ]

Secondary Outcome Measures :
  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 Outcome Measures:
  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 ]


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Ages Eligible for Study:   up to 27 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02437721


Locations
Serbia
KBC Dr Dragiša Mišović-Dedinje
Belgrade, Serbia, 11000
HiPP Clinical Study Center
Belgrade, Serbia
Sponsors and Collaborators
DSM Nutritional Products, Inc.
KBC Dr Dragisa Misovic-Dedinje
HiPP GmbH & Co. Vertrieb KG
Institute for Laboratory Diagnostics Konzilijum
Bevital AS
Charite University, Berlin, Germany
Sermon CRO
Ludwig-Maximilians - University of Munich
Investigators
Principal Investigator: Berthold Koletzko, Prof. Ludwig-Maximilians - University of Munich

Responsible Party: DSM Nutritional Products, Inc.
ClinicalTrials.gov Identifier: NCT02437721     History of Changes
Other Study ID Numbers: 2014-05-06-MTHF
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Folic Acid
Vitamin B Complex
Tetrahydrofolates
Hematinics
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs