Healthy GrowthNCT04671576
Growth and Safety Clinical Trial on a New Infant Formula.
A study testing Organic Infant Formula in people with Healthy Growth, run by Nara Organics at 1 site in United States.
Trial summary
The aim of the study is to assess age-appropriate growth of healthy infants fed a new organic milk-based infant formula. Read more about this study
- Who is it for?
- Ages 1 day to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy Growth
- What is being tested?
- Organic Infant Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2021to 12 Aug 2022
- 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 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy gestational term (≥ 37 wks; ≤ 41 wks and 6 days).
- Birth weight of ≥ 2,500 g and ≤ 4,500 g.
- Postnatal age ≤ 14 days.
- Singleton.
- Designated as healthy, that is no recognized diseases.
- Weight, length, weight-for-length, and head circumference within ≥ 5th and ≤ 95th percentile for age-sex according to World Health Organization (WHO) growth standards (birth to 24 months).
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- Exclusive feeding and tolerating cow milk formula at time of enrollment.
- Parent(s) or legal guardians are willing and able to feed the assigned formula as sole source of nutrition.
- Parent(s) or legal guardians are willing and able to participate in anthropometric procedures.
- Parent(s) or legal guardians have voluntarily signed and dated required participation forms, such as the ICF approved by an IRB.
Who cannot join
- An infant from a multiple birth, such as twin, triplet, or the like.
- Personal or immediate family history of cow-milk protein allergy or intolerance.
- Currently on any medication to treat growth failure or that may significantly impact growth.
- Evidence of any anatomic and/or physiologic condition that would interfere with normal growth, development, or feeding, such as genetic, neurological, gastrointestinal, cardiac, pulmonary, hepatic, or renal.
- A maternal history with known adverse effects on the fetus and/or the newborn infant, such as positive HIV, insulin-dependent diabetes, opioid exposure during pregnancy.
- Enrolled in another clinical trial involving a drug, nutrition supplement, device, or intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Growth and Safety of Healthy Term Infants Consuming an Organic Formula.
The aim of the study is to assess age-appropriate growth of healthy infants fed a new organic milk-based infant formula.
Read the detailed description
A 16-weeks length, randomized, controlled, double-blind, parallel study designed to evaluate growth and tolerance of healthy infants fed milk-based infant formula. The study has been designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations 21 CFR 106.96
- Conditions
- Healthy Growth
- Being tested
- Control Infant Formula, Organic Infant Formula
- Keywords
- infant formula, cow milk, growth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control Infant FormulaOther
Powder, standard commercial infant formula.
Organic Infant FormulaOther
Powder, organic milk-based infant formula.
| Study group | Role | What they receive |
|---|---|---|
| Control Formula | Active comparator | A standard, milk-based, infant formula. Receives: Other: Control Infant Formula |
| Investigational Formula | Experimental | An organic milk-based infant formula. Receives: Other: Organic Infant Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Formula intake.
Volume of formula consumed. ml/day
Measured: Study Day 1 to Study Day 112
Weight.
Weight. Weight gain velocity. g and g/day
Measured: Study Day 1 to Study Day 112
Length.
Length. Length gain velocity. cm and cm/day.
Measured: Study Day 1 to Study Day 112
Head circumference.
Head circumference. Head circumference gain velocity. cm and cm/day
Measured: Study Day 1 to Study Day 112
Anthropometry Z-scores.
Weight for age Z-score. Length for age Z-score. Weight for length Z-score. Head circumference for age Z-score.
Measured: Study Day 1 to Study Day 112
Secondary outcomes (2)
Formula tolerance.
Frequency of adverse events. Fussiness. Inconsolable crying.
Measured: Study Day 1 to Study Day 112
Gastrointestinal characteristic.
Stool consistency. Stools/day. Regurgitation. Gas.
Measured: Study Day 1 to Study Day 112
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start12 Feb 2021
- Primary completion12 Aug 2022
- Study completion12 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy GrowthStudies of the same condition, open and under way.
- 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
- Model description
- A controlled, decentralized, double-blind trial of healthy, term, formula-fed infants randomized to one of two infant formulas: Control Formula (a standard, commercially available infant formula) or Investigational Formula for 16 weeks.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nara Organics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Paidion Research, Inc.
- Responsible party
- Sponsor
- Investigators
- Amanda Fingarson, DO, Study director, Paidion Research, Inc.Tiffany Petty, MD, Principal investigator, Telehub Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04671576
- Sponsor's protocol ID
- NA-101-19
- Status last verified
- Aug 2022
- First submitted
- 11 Dec 2020
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Growth and Safety of Healthy Term Infants Consuming an Organic Formula.
- ClinicalTrials.gov ID
- NCT04671576
- Acronym / sponsor ID
- NA-101-19
- Conditions
- Healthy Growth
- Keywords
- infant formula, cow milk, growth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Nara OrganicsIndustry (pharma, biotech, devices)
- Collaborators
- Paidion Research, Inc.
- Study start
- 12 Feb 2021 (actual)
- Primary completion
- 12 Aug 2022 (actual)
- Study completion
- 12 Aug 2022 (actual)
- First posted
- 17 Dec 2020 (actual)
- 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.
The aim of the study is to assess age-appropriate growth of healthy infants fed a new organic milk-based infant formula.
Detailed description
A 16-weeks length, randomized, controlled, double-blind, parallel study designed to evaluate growth and tolerance of healthy infants fed milk-based infant formula. The study has been designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations 21 CFR 106.96
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A controlled, decentralized, double-blind trial of healthy, term, formula-fed infants randomized to one of two infant formulas: Control Formula (a standard, commercially available infant formula) or Investigational Formula for 16 weeks.
| Arm | Type | Receives |
|---|---|---|
| Control Formula | Active comparator | Other: Control Infant FormulaA standard, milk-based, infant formula. |
| Investigational Formula | Experimental | Other: Organic Infant FormulaAn organic milk-based infant formula. |
Who may qualify
- Ages
- 1 day to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Healthy gestational term (≥ 37 wks; ≤ 41 wks and 6 days).
- Birth weight of ≥ 2,500 g and ≤ 4,500 g.
- Postnatal age ≤ 14 days.
- Singleton.
- Designated as healthy, that is no recognized diseases.
Key exclusion criteria (6 listed)
- An infant from a multiple birth, such as twin, triplet, or the like.
- Personal or immediate family history of cow-milk protein allergy or intolerance.
- Currently on any medication to treat growth failure or that may significantly impact growth.
- Evidence of any anatomic and/or physiologic condition that would interfere with normal growth, development, or feeding, such as genetic, neurological, gastrointestinal, cardiac, pulmonary, hepatic, or renal.
- A maternal history with known adverse effects on the fetus and/or the newborn infant, such as positive HIV, insulin-dependent diabetes, opioid exposure during pregnancy.
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 |
|---|---|---|
| Control Infant FormulaPowder, standard commercial infant formula. | Other | Control Formula |
| Organic Infant FormulaPowder, organic milk-based infant formula. | Other | Investigational Formula |
Primary outcome
Formula intake.
Time frame: Study Day 1 to Study Day 112
Volume of formula consumed. ml/day
Weight.
Time frame: Study Day 1 to Study Day 112
Weight. Weight gain velocity. g and g/day
Length.
Time frame: Study Day 1 to Study Day 112
Length. Length gain velocity. cm and cm/day.
Head circumference.
Time frame: Study Day 1 to Study Day 112
Head circumference. Head circumference gain velocity. cm and cm/day
Anthropometry Z-scores.
Time frame: Study Day 1 to Study Day 112
Weight for age Z-score. Length for age Z-score. Weight for length Z-score. Head circumference for age Z-score.
2 secondary outcomes
Formula tolerance.
Time frame: Study Day 1 to Study Day 112
Gastrointestinal characteristic.
Time frame: Study Day 1 to Study Day 112
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 28 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Amanda Fingarson, DO study director
Paidion Research, Inc.
Tiffany Petty, MD principal investigator
Telehub Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Organic Infant Formula in people with Healthy Growth, run by Nara Organics at 1 site in United States.
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 10 inclusion and 6 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 28 Sep 2022. 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 United States. 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?
Formula intake. (time frame: Study Day 1 to Study Day 112). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2022.