Growth and Safety Clinical Trial on a New Infant Formula.

Healthy Growth Clinical Trial

Official title:

Evaluation of Growth and Safety of Healthy Term Infants Consuming an Organic Formula.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04671576
• Other study ID #: NA-101-19
• Status: Completed
• Phase: N/A
• Start date: February 12, 2021
• Est. completion date: August 12, 2022

Study information

• Verified date: August 2022
• Source: Nara Organics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: August 12, 2022
• Est. primary completion date: August 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 14 Days

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Growth

Intervention

Other:
• Control Infant Formula
Powder, standard commercial infant formula.
• Organic Infant Formula
Powder, organic milk-based infant formula.

Locations

Country	Name	City	State
United States	TeleResearch Hub	Cary	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Nara Organics	Paidion Research, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Formula intake.	Volume of formula consumed. ml/day	Study Day 1 to Study Day 112
Primary	Weight.	Weight. Weight gain velocity. g and g/day	Study Day 1 to Study Day 112
Primary	Length.	Length. Length gain velocity. cm and cm/day.	Study Day 1 to Study Day 112
Primary	Head circumference.	Head circumference. Head circumference gain velocity. cm and cm/day	Study Day 1 to Study Day 112
Primary	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	Formula tolerance.	Frequency of adverse events. Fussiness. Inconsolable crying.	Study Day 1 to Study Day 112
Secondary	Gastrointestinal characteristic.	Stool consistency. Stools/day. Regurgitation. Gas.	Study Day 1 to Study Day 112