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Growth and Safety Clinical Trial on a New Infant Formula.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04671576
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : December 9, 2021
Sponsor:
Collaborator:
Paidion Research, Inc.
Information provided by (Responsible Party):
Nara Organics

Study Description
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Brief Summary:
The aim of the study is to assess age-appropriate growth of healthy infants fed a new organic milk-based infant formula.

Condition or disease Intervention/treatment Phase
Healthy Growth Other: Control Infant Formula Other: Organic Infant Formula Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Evaluation of Growth and Safety of Healthy Term Infants Consuming an Organic Formula.
Actual Study Start Date : January 19, 2021
Estimated Primary Completion Date : July 2, 2022
Estimated Study Completion Date : September 2, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Control Formula
A standard, milk-based, infant formula.
 Other: Control Infant Formula
Powder, standard commercial infant formula.
Experimental: Investigational Formula
An organic milk-based infant formula.
 Other: Organic Infant Formula
Powder, organic milk-based infant formula.


Outcome Measures
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Primary Outcome Measures :
  1. Formula intake. [ Time Frame: Study Day 1 to Study Day 112 ]
    Volume of formula consumed. ml/day

  2. Weight. [ Time Frame: Study Day 1 to Study Day 112 ]
    Weight. Weight gain velocity. g and g/day

  3. Length. [ Time Frame: Study Day 1 to Study Day 112 ]
    Length. Length gain velocity. cm and cm/day.

  4. Head circumference. [ Time Frame: Study Day 1 to Study Day 112 ]
    Head circumference. Head circumference gain velocity. cm and cm/day

  5. 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.


Secondary Outcome Measures :
  1. Formula tolerance. [ Time Frame: Study Day 1 to Study Day 112 ]
    Frequency of adverse events. Fussiness. Inconsolable crying.

  2. Gastrointestinal characteristic. [ Time Frame: Study Day 1 to Study Day 112 ]
    Stool consistency. Stools/day. Regurgitation. Gas.


Eligibility Criteria
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Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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).
  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT04671576


Contacts
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Contact: Juan M Gonzalez, PhD 1-646-389-2527 juan@naraorganics.com
Contact: Esther Hallam 1-646-389-2527 esther@naraorganics.com

Locations
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United States, North Carolina
TeleResearch Hub Recruiting
Cary, North Carolina, United States, 27519
Contact: Tiffany Petty, MD    984-345-3662 ext 246      
Sponsors and Collaborators
Nara Organics
Paidion Research, Inc.
Investigators
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Study Director: Mera Goodman, MD Paidion Research, Inc.
Principal Investigator: Tiffany Petty, MD Telehub Research
More Information
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Responsible Party: Nara Organics
ClinicalTrials.gov Identifier: NCT04671576    
Other Study ID Numbers: NA-101-19
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: December 9, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nara Organics:
infant formula
cow milk
growth