NCT01094080

Brief Summary

In this study, the suitability of an infant formula with a modified content of protein and fatty acid pattern (LC-PUFA) for healthy term infants will be investigated. Primary hypothesis to be tested is: an infant formula with a modified protein content is non inferior compared to a standard infant formula in respect to the growth of healthy term infants.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
505

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2010

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2010

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 26, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
6.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

September 2, 2020

Status Verified

September 1, 2020

Enrollment Period

1.6 years

First QC Date

February 1, 2010

Last Update Submit

September 1, 2020

Conditions

Infant Nutrition

Keywords

fully formula fedfully breast fed

Outcome Measures

Primary Outcomes (1)

  • change of weight from day 30 to day 120

    postnatal age 30 to 120 days

Secondary Outcomes (4)

  • anthropometry

    postnatal day 30, day 60, day 90, day 120 days

  • blood markers

    postnatal day 30, day 60, day 90, day 120 days (120 only)

  • Follow-up

    4 Years of age

  • Follow-up at age 7 years with an interview regarding severe events and growth

    7 years of age

Study Arms (3)

standard infant formula

ACTIVE COMPARATOR

infants are fed a commercial formula during the first 4 month of life, according to protocol

Other: standard infant formula

modified infant formula

EXPERIMENTAL

infants are fed a modified infant formula (modified protein content and fatty acid pattern) during the first 4 month of life, according to protocol

Other: modified infant formula

breast milk

OTHER

infants are breast fed

Other: breast milk

Interventions

standard infant formulaOTHER

infants are fed a commercial formula

standard infant formula
modified infant formulaOTHER

the modified infant formula has a different protein content than the standard formula and long chain polyunsaturated fatty acids are added

modified infant formula
breast milkOTHER

infants are breast fed

breast milk

Eligibility Criteria

Age3 Days - 28 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • healthy term newborn
  • gestational age between 37 and 41 weeks
  • birth weight between the 3th and 97th weight-for-age percentile according to the EURO-Growth charts
  • fully bottle-fed (at the latest with 28 days of age) or fully breast fed
  • written parental informed consent
  • Serbian nationality

You may not qualify if:

  • malformations, congenital heart defect, congenital vascular disease, severe diseases of gastrointestinal tract, kidney, liver, central nervous system and/or metabolic disease
  • intensive care during first 14 days of life
  • participation in any other clinical study intervention
  • twins, multiple birth
  • neonatal infection
  • medication and parenteral nutrition
  • metabolic disorders
  • birth-related complications
  • severe disturbances of neonatal adaption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hauner Childrens Hospital, LudwigMaximilans Universität

München, D-80337, Germany

Location

Institute for Gynecology and Obstretition of Clinical Center

Belgrade, 11000, Serbia

Location

Related Publications (2)

  • Fleddermann M, Demmelmair H, Grote V, Nikolic T, Trisic B, Koletzko B. Infant formula composition affects energetic efficiency for growth: the BeMIM study, a randomized controlled trial. Clin Nutr. 2014 Aug;33(4):588-95. doi: 10.1016/j.clnu.2013.12.007. Epub 2013 Dec 30.

    PMID: 24411489RESULT

  • Fleddermann M, Demmelmair H, Grote V, Bidlingmaier M, Grimminger P, Bielohuby M, Koletzko B. Role of selected amino acids on plasma IGF-I concentration in infants. Eur J Nutr. 2017 Mar;56(2):613-620. doi: 10.1007/s00394-015-1105-9. Epub 2015 Nov 30.

    PMID: 26621633RESULT

MeSH Terms

Interventions

Milk, Human

Intervention Hierarchy (Ancestors)

MilkBeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Study Officials

  • Berthold Koletzko, Prof.

    Hauner Children Hospital, Ludwig Maximilians Universität

    STUDY DIRECTOR

  • Tatjana Nicolić Nicolić, Dr.

    Institute for Gynecology and Obstretition of Clinical Center Belgrade

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

February 1, 2010

First Posted

March 26, 2010

Study Start

February 1, 2010

Primary Completion

September 1, 2011

Study Completion

May 1, 2018

Last Updated

September 2, 2020

Record last verified: 2020-09

Locations

DE(1)SE(1)