Growth and Safety Clinical Trial on a New Infant Formula.

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.

Study Overview

• Status: Completed
• Conditions: Healthy Growth
• Intervention / Treatment: Other: Control Infant Formula; Other: Organic 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 Type: Interventional
• Enrollment (Actual): 176
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Cary, North Carolina, United States, 27519
      • TeleResearch Hub

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Formula intake.	Volume of formula consumed. ml/day	Study Day 1 to Study Day 112
Weight.	Weight. Weight gain velocity. g and g/day	Study Day 1 to Study Day 112
Length.	Length. Length gain velocity. cm and cm/day.	Study Day 1 to Study Day 112
Head circumference.	Head circumference. Head circumference gain velocity. cm and cm/day	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.	Study Day 1 to Study Day 112

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Formula tolerance.	Frequency of adverse events. Fussiness. Inconsolable crying.	Study Day 1 to Study Day 112
Gastrointestinal characteristic.	Stool consistency. Stools/day. Regurgitation. Gas.	Study Day 1 to Study Day 112

Collaborators and Investigators

• Sponsor: Nara Organics
• Collaborators: Paidion Research, Inc.
• Investigators: Study Director: Amanda Fingarson, DO, Paidion Research, Inc.; Principal Investigator: Tiffany Petty, MD, Telehub Research

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2021
• Primary Completion (Actual): August 12, 2022
• Study Completion (Actual): August 12, 2022

Study Registration Dates

• First Submitted: December 11, 2020
• First Submitted That Met QC Criteria: December 11, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: growth; infant formula; cow milk
• Other Study ID Numbers: NA-101-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No