Suitability of an Infant Formula With L-5-Methyltetrahydrofolate for the Particular Nutritional Use in Infants
NCT ID: NCT02437721
Last Updated: 2018-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
360 participants
INTERVENTIONAL
2015-05-31
2018-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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infant formula containing folic acid
Infant formula including folic acid within the range stipulated by European legislation on infant formula
infant formula containing folic acid
infant formula containing MTHF
Infant formula including MTHF instead of folic acid
infant formula containing MTHF
Breast milk
non randomized reference group
No interventions assigned to this group
Interventions
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infant formula containing folic acid
infant formula containing MTHF
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
1 Day
27 Days
ALL
Yes
Sponsors
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University Clinic Dr Dragisa Misovic-Dedinje
OTHER
HiPP GmbH & Co. Vertrieb KG
INDUSTRY
Institute for Laboratory Diagnostics Konzilijum
UNKNOWN
Bevital AS
UNKNOWN
Charite University, Berlin, Germany
OTHER
Sermon CRO
INDUSTRY
Ludwig-Maximilians - University of Munich
OTHER
DSM Nutritional Products, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Berthold Koletzko, Prof.
Role: PRINCIPAL_INVESTIGATOR
Ludwig-Maximilians - University of Munich
Locations
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KBC Dr Dragiša Mišović-Dedinje
Belgrade, , Serbia
HiPP Clinical Study Center
Belgrade, , Serbia
Countries
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References
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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.
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.
Other Identifiers
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2014-05-06-MTHF
Identifier Type: -
Identifier Source: org_study_id
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