Growth and Safety Clinical Trial on a New Infant Formula.

NCT04671576 | Completed DMC

• 1 other identifier: NA-101-19
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Growth

Keywords

infant formula; cow milk; growth

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Formula tolerance.

  Study Day 1 to Study Day 112

• Gastrointestinal characteristic.

  Study Day 1 to Study Day 112

Study Arms (2)

Control Formula

ACTIVE COMPARATOR

A standard, milk-based, infant formula.

Other: Control Infant Formula

Investigational Formula

EXPERIMENTAL

An organic milk-based infant formula.

Other: Organic Infant Formula

Interventions

Control Infant Formula OTHER

Powder, standard commercial infant formula.

Control Formula

Organic Infant Formula OTHER

Powder, organic milk-based infant formula.

Investigational Formula

Eligibility Criteria

• Age: 1 Day - 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nara Organics: lead
• Paidion Research, Inc.: collaborator

Study Sites (1)

TeleResearch Hub

Cary, North Carolina, 27519, United States

Location

Study Officials

• Amanda Fingarson, DO

  Paidion Research, Inc.

  STUDY DIRECTOR

• Tiffany Petty, MD

  Telehub Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 17, 2020
• Study Start: February 12, 2021
• Primary Completion: August 12, 2022
• Study Completion: August 12, 2022
• Last Updated: September 28, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)