Clinical Evaluation of a Low Protein Content Formula in the First Months of Life: a RCT
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|ClinicalTrials.gov Identifier: NCT03035721|
Recruitment Status : Completed
First Posted : January 30, 2017
Last Update Posted : June 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Safety Issues Infant Nutrition Disorders||Dietary Supplement: Low protein formula Dietary Supplement: Standard protein formula||Not Applicable|
Infants were randomized to receive either a standard protein formula or a low-protein formula. The composition of the low-protein formula vs the standard formula was: energy (65 vs. 68 kcal/100 mL), protein (1.2 vs. 1.7 g/100 mL).
To investigate the safety of the low-protein formula without any bias, a 4-month intervention period was selected during which the infants were fed only formula.
Anthropometric parameters (weight, length, and head circumference) and body composition were assessed at enrollment, at 2 and 4 months' of age. Parents were asked to keep a diary on the occurrence of gastrointestinal symptoms or any other symptoms and were contacted every two weeks either by clinic visits or phone calls.
The reference group was constituted by a cohort of healthy, exclusively breastfed, full-term infants.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Anthropometric and body composition measurements were performed by three medical investigators who were blinded to allocated treatment.|
|Official Title:||Clinical Evaluation of a Low Protein Content Formula Fed to Full Term Healthy Infants in the First Months of Life: a Randomized Controlled Trial|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||June 2016|
Experimental: Low protein formula group
Full term healthy infants randomized to receive a low protein formula for the first 4 months of life
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.
Active Comparator: Standard protein formula group
Full term healthy infants randomized to receive a standard protein formula for the first 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.
No Intervention: Breastfeeding group
Breastfed full term healthy infants
- Evaluate weight [ Time Frame: enrollment, 2 months and 4 months ]Weight (g) of each baby was measured on an electronic scale accurate to 0.1 g (PEA POD Infant Body Composition System; Cosmed, Concord, CA, US). Body length was measured to the nearest 1 mm on a Harpenden neonatometer (Holtain, Crymych, UK).
- Evaluate lenght [ Time Frame: enrollment 2 months and 4 months ]Lenght (cm) of each baby was measured according standard procedures.
- Evaluate head circumference [ Time Frame: enrollment 2 months and 4 months ]Head circumference was measured to the nearest 1 mm using non-stretch measuring tape.
- Evaluate body composition (fat mass and fat free mass) [ Time Frame: enrollment, 2 months and 4 months ]Body composition [fat mass and fat free mass (g)]was assessed using an air-displacement plethysmography (PEA POD Infant Body Composition System; COSMED, Italy).
- Evaluate weight increase [ Time Frame: 2 months, 4 months ]Weight increase (g/day) was calculated as a change in body weight from weight at study enrollment divided by the time interval from enrolment to the assessment at 4 months Fat mass (g/day) and fat free mass (g/day) increases were also calculated.
- Evaluate gastrointestinal tolerance [ Time Frame: 2 months and 4 months ]
Parents were asked to keep a diary on the occurrence of gastrointestinal symptoms or any other symptoms and were contacted every two weeks either by clinic visits or phone calls.
The occurrence of spitting up, vomiting and colic, defined as intermittent attacks of abdominal pain when the baby screamed and drew up his/her legs but was well between episodes, was recorded. Colic was further classified as severe if the episodes were more than twice per day. Daily frequency of stool passage was also collected.
- Evaluate occurence of adverse events [ Time Frame: 2 months and 4 months ]Adverse events were assessed based on inquires to the parents and on their daily records.
- Evaluate body mass index (k/m2: weight/length2) [ Time Frame: enrollment, 2 months and 4 months ]Body mass index [BMI: (Kg/m2)] was assessed for all infants enrolled at each study points.
- Evaluate z-score [ Time Frame: enrollment, 2 months and 4 months ]Z-scores values for age were then calculated using the z score calculator provided by WHO [WHO Anthro (version 3.2.2, January 2011)].
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035721
|NICU, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milan|
|Milano, Italy, 20122|
|Principal Investigator:||Paola Roggero, MD||NICU. Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano, Milan, Italy, 20122|