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

Growth and Development Clinical Trial

— MEFOLIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02437721
• Other study ID #: 2014-05-06-MTHF
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: March 2018

Study information

• Verified date: January 2018
• Source: DSM Nutritional Products, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: March 2018
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 27 Days

Eligibility

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

Related Conditions & MeSH terms

• Growth and Development

Intervention

Other:
• infant formula containing folic acid

• infant formula containing MTHF

Locations

Country	Name	City	State
Serbia	HiPP Clinical Study Center	Belgrade
Serbia	KBC Dr Dragiša Mišovic-Dedinje	Belgrade

Sponsors (8)

Lead Sponsor	Collaborator
DSM Nutritional Products, Inc.	Bevital AS, Charite University, Berlin, Germany, HiPP GmbH & Co. Vertrieb KG, Institute for Laboratory Diagnostics Konzilijum, KBC Dr Dragisa Misovic-Dedinje, Ludwig-Maximilians - University of Munich, Sermon CRO

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	plasma levels of 5-MTHF in infants		at age of 4 weeks and at the age of 16 weeks
Other	plasma levels of folic acid in infants		at age of 4 weeks and at the age of 16 weeks
Other	plasma levels of 5-Formyl-tetrahydrofolate (fTHF) in infants		at age of 4 weeks and at the age of 16 weeks
Other	plasma levels of 4-Alfa-hydroxy-5-methyl-THF (hmTHF) in infants		at age of 4 weeks and at the age of 16 weeks
Other	plasma levels of Para-aminobenzoylglutamate (pABG) in infants		at age of 4 weeks and at the age of 16 weeks
Other	plasma levels of Acetamidobenzoylglutamate (apABG) in infants		at age of 4 weeks and at the age of 16 weeks
Other	red cell total folate in infants		at age of 4 weeks and at the age of 16 weeks
Other	plasma levels of 5-MTHF in breast feeding mothers		at the infantile age of 8 weeks
Other	breast milk levels of 5-MTHF in breast feeding mothers		at the infantile age of 8 weeks
Other	plasma levels of folic acid in breast feeding mothers		at the infantile age of 8 weeks
Other	breast milk levels of folic acid in breast feeding mothers		at the infantile age of 8 weeks
Other	plasma levels of fTHF in breast feeding mothers		at the infantile age of 8 weeks
Other	breast milk levels of fTHF in breast feeding mothers		at the infantile age of 8 weeks
Other	plasma levels of hmTHF in breast feeding mothers		at the infantile age of 8 weeks
Other	breast milk levels of hmTHF in breast feeding mothers		at the infantile age of 8 weeks
Other	plasma levels of pABG in breast feeding mothers		at the infantile age of 8 weeks
Other	breast milk levels of pABG in breast feeding mothers		at the infantile age of 8 weeks
Other	plasma levels of apABG in breast feeding mothers		at the infantile age of 8 weeks
Other	breast milk levels of apABG in breast feeding mothers		at the infantile age of 8 weeks
Other	hemoglobin value of the breast feeding mothers		at the infantile age of 8 weeks
Other	hematocrit value of the breast feeding mothers		at the infantile age of 8 weeks
Other	mean corpuscular volume (MCV) of the breast feeding mothers		at the infantile age of 8 weeks
Other	weight of infants		at infantile age 1 year
Other	length of infants		at infantile age 1 year
Other	head circumference of infants		at infantile age 1 year
Other	hemoglobin value of infants		between Day 1 and Day 27 of life, at infantile age of 16 weeks and of 12 months
Other	hematocrit value of infants		between Day 1 and Day 27 of life, at infantile age of 16 weeks and of 12 months
Other	mean corpuscular volume (MCV) of infants		between Day 1 and Day 27 of life, at infantile age of 16 weeks and of 12 months
Other	infantile genotype of methylenetetrahydrofolate-reductase		at infantile age 4 weeks
Other	intake of folic acid in breast feeding mothers		at the infantile age of 8 weeks
Other	intake of MTHF in breast feeding mothers		at the infantile age of 8 weeks
Primary	weight gain (gram/day)		age of 4 weeks until age of 16 weeks
Secondary	body length gain (cm/day)		age of 4 weeks until age of 16 weeks
Secondary	fronto-occipital head circumference gain (in cm/day)		at age of 4 weeks and at the age of 16 weeks
Secondary	dietary intake of study formula, non-study formula, additional liquids and solids	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
Secondary	feeding related behavior questionnaire		during the period age 4 weeks to age 16 weeks
Secondary	stool characteristics (color and consistency)	stool characteristics are assessed by the Bristol scale criteria	during the period age 4 weeks to age 16 weeks