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Growth and DevelopmentMEFOLINNCT02437721

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

A study testing infant formula containing folic acid and infant formula containing MTHF in people with Growth and Development, run by dsm-firmenich Switzerland AG at 2 sites in Serbia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 1 day to 27 daysHealthy volunteers can take part
Conditions the study is for
Growth and Development
What is being tested?
infant formula containing folic acid and infant formula containing MTHF
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
2 sitesSerbia
Study dates
May 2015to Mar 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 day to 27 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Serbia2 sites

  • KBC Dr Dragiša Mišović-Dedinje

    Belgrade, 11000

  • HiPP Clinical Study Center

    Belgrade

Other trials in Serbia

About this study

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.

Being tested
infant formula containing folic acid, infant formula containing MTHF

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • infant formula containing folic acidOther

    Also called folic acid

  • infant formula containing MTHFOther

    Also called L-5-Methyltetrahydrofolate

Study groups in NCT02437721
Study groupRoleWhat they receive
infant formula containing folic acidActive comparatorInfant formula including folic acid within the range stipulated by European legislation on infant formula
Receives: Other: infant formula containing folic acid
infant formula containing MTHFExperimentalInfant formula including MTHF instead of folic acid
Receives: Other: infant formula containing MTHF
Breast milkNo interventionnon randomized reference group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. weight gain (gram/day)

    Measured: age of 4 weeks until age of 16 weeks

Secondary outcomes (5)

  1. body length gain (cm/day)

    Measured: age of 4 weeks until age of 16 weeks

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

    Measured: 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

    dietary intake will be determined as kcal per day and as kcal per kg body weight per day

    Measured: during the period age 4 weeks to age 16 weeks

  4. feeding related behavior questionnaire

    Measured: during the period age 4 weeks to age 16 weeks

  5. stool characteristics (color and consistency)

    stool characteristics are assessed by the Bristol scale criteria

    Measured: during the period age 4 weeks to age 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionAug 2017
  4. Study completionMar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
360 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02437721
Sponsor's protocol ID
2014-05-06-MTHF
Acronym
MEFOLIN
Status last verified
Jan 2018
First submitted
30 Mar 2015
Last updated
10 Aug 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 36872017

  • 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.

    PubMed 31425504

Questions about this trial

What is this clinical trial studying?

A study testing infant formula containing folic acid and infant formula containing MTHF in people with Growth and Development, run by dsm-firmenich Switzerland AG at 2 sites in Serbia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

weight gain (gram/day) (time frame: age of 4 weeks until age of 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02437721, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2018.

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