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

Nara Organics2 sites in 1 country176 target enrollmentStarted: February 12, 2021Last updated: September 28, 2022

Conditions

Trial Snapshot

Phase: Not Applicable
Status: Completed
Sponsor
Enrollment: 176
Locations: 2
Primary Endpoint: Head circumference.

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

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

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Other
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages: 1 Day to 14 Days (Child)
Sex: All
Accepts Healthy Volunteers: Yes

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.