Safety IssuesNCT03035721
Clinical Evaluation of a Low Protein Content Formula in the First Months of Life: a RCT
A study testing Low protein formula and Standard protein formula in people with Safety Issues and Infant Nutrition Disorders, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
This study aimed to evaluate the tolerance and safety of a low-protein formula in healthy full-term infants by investigating effects on growth and gastrointestinal tolerance and by identifying any adverse effects. Read more about this study
- Who is it for?
- Ages 1 day to 3 weeksHealthy volunteers can take part
- Conditions the study is for
- Safety Issues, Infant Nutrition Disorders
- What is being tested?
- Low protein formula and Standard protein formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2014to Jun 2016
- 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 3 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy
- singleton
- full-term infants (gestational age 37/0 to 41/6 weeks)
- birth weight adequate for gestational age (>p10 and <p90 for gestational age) according to the World Health Organization growth charts.
Who cannot join
- presence of congenital diseases
- presence of chromosomal abnormalities
- presence of conditions that could interfere with growth, such as brain, metabolic, cardiac and gastrointestinal diseases, perinatal infections.
- being born to mother affected by endocrine and/or metabolic diseases
- having a family history of allergic disease
Trial locations and contacts
1 site in 1 country.
Italy1 site
NICU, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milan
Milan, 20122
About this study
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
This study aimed to evaluate the tolerance and safety of a low-protein formula in healthy full-term infants by investigating effects on growth and gastrointestinal tolerance and by identifying any adverse effects.
Read the detailed description
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.
- Conditions
- Safety Issues, Infant Nutrition Disorders
- Being tested
- Low protein formula, Standard protein formula
- Keywords
- Full term healthy infants, Low protein content formula, Safety, Growth, Body composition
- Medical subject headings
- Infant Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low protein formulaDietary supplement
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.
Standard protein formulaDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Low protein formula group | Experimental | Full term healthy infants randomized to receive a low protein formula for the first 4 months of life Receives: Dietary Supplement: Low protein formula |
| Standard protein formula group | Active comparator | Full term healthy infants randomized to receive a standard protein formula for the first 4 months of life Receives: Dietary Supplement: Standard protein formula |
| Breastfeeding group | No intervention | Breastfed full term healthy infants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate weight
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).
Measured: enrollment, 2 months and 4 months
Evaluate lenght
Lenght (cm) of each baby was measured according standard procedures.
Measured: enrollment 2 months and 4 months
Evaluate head circumference
Head circumference was measured to the nearest 1 mm using non-stretch measuring tape.
Measured: enrollment 2 months and 4 months
Evaluate body composition (fat mass and fat free mass)
Body composition [fat mass and fat free mass (g)]was assessed using an air-displacement plethysmography (PEA POD Infant Body Composition System; COSMED, Italy).
Measured: enrollment, 2 months and 4 months
Evaluate weight increase
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.
Measured: 2 months, 4 months
Evaluate gastrointestinal tolerance
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.
Measured: 2 months and 4 months
Evaluate occurence of adverse events
Adverse events were assessed based on inquires to the parents and on their daily records.
Measured: 2 months and 4 months
Secondary outcomes (2)
Evaluate body mass index (k/m2: weight/length2)
Body mass index [BMI: (Kg/m2)] was assessed for all infants enrolled at each study points.
Measured: enrollment, 2 months and 4 months
Evaluate z-score
Z-scores values for age were then calculated using the z score calculator provided by WHO [WHO Anthro (version 3.2.2, January 2011)].
Measured: enrollment, 2 months and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study startJun 2014
- Primary completionJan 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Humana Co.Ltd.
- Responsible party
- Sponsor
- Investigators
- Paola Roggero, MD, Principal investigator, NICU. Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano, Milan, Italy, 20122
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035721
- Sponsor's protocol ID
- Low protein formula_RCT
- Status last verified
- Jan 2017
- First submitted
- 17 Jan 2017
- Last updated
- 29 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Liotto N, Orsi A, Menis C, Piemontese P, Morlacchi L, Condello CC, Gianni ML, Roggero P, Mosca F. Clinical evaluation of two different protein content formulas fed to full-term healthy infants: a randomized controlled trial. BMC Pediatr. 2018 Feb 13;18(1):59. doi: 10.1186/s12887-018-1046-6.
PubMed 29439736
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03035721
- Acronym / sponsor ID
- Low protein formula_RCT
- Conditions
- Safety Issues, Infant Nutrition Disorders
- Keywords
- Full term healthy infants, Low protein content formula, Safety, Growth, Body composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Collaborators
- Humana Co.Ltd.
- Study start
- Jun 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 30 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to evaluate the tolerance and safety of a low-protein formula in healthy full-term infants by investigating effects on growth and gastrointestinal tolerance and by identifying any adverse effects.
Detailed description
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low protein formula group | Experimental | Dietary Supplement: Low protein formulaFull term healthy infants randomized to receive a low protein formula for the first 4 months of life |
| Standard protein formula group | Active comparator | Dietary Supplement: Standard protein formulaFull term healthy infants randomized to receive a standard protein formula for the first 4 months of life |
| Breastfeeding group | No intervention | –Breastfed full term healthy infants |
Who may qualify
- Ages
- 1 day to 3 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- healthy
- singleton
- full-term infants (gestational age 37/0 to 41/6 weeks)
- birth weight adequate for gestational age (>p10 and <p90 for gestational age) according to the World Health Organization growth charts.
Key exclusion criteria (5 listed)
- presence of congenital diseases
- presence of chromosomal abnormalities
- presence of conditions that could interfere with growth, such as brain, metabolic, cardiac and gastrointestinal diseases, perinatal infections.
- being born to mother affected by endocrine and/or metabolic diseases
- having a family history of allergic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low protein formulaInfants 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 | Low protein formula group |
| Standard protein formulaInfants 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. | Dietary supplement | Standard protein formula group |
Primary outcome
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.
2 secondary outcomes
Evaluate body mass index (k/m2: weight/length2)
Time frame: enrollment, 2 months and 4 months
Evaluate z-score
Time frame: enrollment, 2 months and 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2017.
- Derived from this study: PubMed 29439736Liotto N, Orsi A, Menis C, Piemontese P, Morlacchi L, Condello CC, Gianni ML, Roggero P, Mosca F. Clinical evaluation of two different protein content formulas fed to full-term healthy infants: a randomized controlled trial. BMC Pediatr. 2018 Feb 13;18(1):59. doi: 10.1186/s12887-018-1046-6.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paola Roggero, MD principal investigator
NICU. Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano, Milan, Italy, 20122
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low protein formula and Standard protein formula in people with Safety Issues and Infant Nutrition Disorders, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
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 4 inclusion and 5 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 29 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Evaluate weight (time frame: enrollment, 2 months and 4 months). The study lists 7 primary outcomes in all. 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 NCT03035721, which also lists 1 linked publication.
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 29 Jun 2017.