Growth and Safety Clinical Trial on a New Infant Formula.

NCT ID: NCT04671576

Last Updated: 2022-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 176 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-12
• Study Completion Date: 2022-08-12

Brief Summary

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

Conditions

Healthy Growth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Control Formula

A standard, milk-based, infant formula.

Group Type: ACTIVE_COMPARATOR

Control Infant Formula

Intervention Type: OTHER

Powder, standard commercial infant formula.

Investigational Formula

An organic milk-based infant formula.

Group Type: EXPERIMENTAL

Organic Infant Formula

Intervention Type: OTHER

Powder, organic milk-based infant formula.

Interventions

Control Infant Formula

Powder, standard commercial infant formula.

Intervention Type: OTHER

Organic Infant Formula

Powder, organic milk-based infant formula.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 14 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Paidion Research, Inc.

INDUSTRY

Sponsor Role: collaborator

Nara Organics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amanda Fingarson, DO

Role: STUDY_DIRECTOR

Paidion Research, Inc.

Tiffany Petty, MD

Role: PRINCIPAL_INVESTIGATOR

Telehub Research

Locations

TeleResearch Hub

Cary, North Carolina, United States

Countries

United States

Other Identifiers

NA-101-19

Identifier Type: -

Identifier Source: org_study_id