Clinical Evaluation of a Low Protein Content Formula in the First Months of Life: a RCT

NACompletedINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

June 30, 2014

Primary Completion Date

January 31, 2016

Study Completion Date

June 30, 2016

Conditions
Safety IssuesInfant Nutrition Disorders
Interventions
DIETARY_SUPPLEMENT

Low protein formula

Infants were enrolled to receive low protein formula (energy: 65 kcal/100 mL, protein: 1.2 g/100 mL, protein-to-energy ratio:1.9 g/100 kcal, carbohydrates: 8 g/100 mL, fat: 3.1 g/100 mL) for the firsts 4 months of life.

DIETARY_SUPPLEMENT

Standard protein formula

Infants were enrolled to receive standard protein formula (energy: 68 kcal/100 mL, protein: 1.7 g/100 mL, protein-to-energy ratio:2.5 g/100 kcal, carbohydrates: 7.1 g/100 mL, fat: 3.5 g/100 mL) for the firsts 4 months of life.

Trial Locations (1)

20122

NICU, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milan, Milan

All Listed Sponsors
collaborator

Humana Co.Ltd.

INDUSTRY

lead

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

NCT03035721 - Clinical Evaluation of a Low Protein Content Formula in the First Months of Life: a RCT | Biotech Hunter | Biotech Hunter