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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02437721 |
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Date of registration:
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30/03/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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Suitability of an Infant Formula With L-5-Methyltetrahydrofolate for the Particular Nutritional Use in Infants |
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Date of first enrolment:
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May 2015 |
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Target sample size:
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360 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02437721 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Serbia
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Contacts
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Name:
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Berthold Koletzko, Prof. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ludwig-Maximilians - University of Munich |
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
27 Days
Gender:
All
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Health Condition(s) or Problem(s) studied
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Growth and Development
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Intervention(s)
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Other: infant formula containing folic acid
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Other: infant formula containing MTHF
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Primary Outcome(s)
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weight gain (gram/day)
[Time Frame: age of 4 weeks until age of 16 weeks]
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Secondary Outcome(s)
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fronto-occipital head circumference gain (in cm/day)
[Time Frame: at age of 4 weeks and at the age of 16 weeks]
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body length gain (cm/day)
[Time Frame: age of 4 weeks until age of 16 weeks]
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stool characteristics (color and consistency)
[Time Frame: during the period age 4 weeks to age 16 weeks]
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dietary intake of study formula, non-study formula, additional liquids and solids
[Time Frame: during the period age 4 weeks to age 16 weeks]
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feeding related behavior questionnaire
[Time Frame: during the period age 4 weeks to age 16 weeks]
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Secondary ID(s)
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2014-05-06-MTHF
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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