DHA Proof-of-Concept Study in Infants and Toddlers (DHA)

Effect of a Liquid Oral Supplement Comprising a Blend of Glycerides at Certain Proportions on Infant and Toddler DHA Status

This is a prospective, double blind, randomized, controlled proof-of-concept study with a parallel group design that aims to investigate the effect of a liquid oral supplement comprising a blend of glycerides at certain proportions on infant and toddler DHA status.

Study Overview

• Status: Withdrawn
• Conditions: Toddlers; Infants; Nutritional Supplement
• Intervention / Treatment: Other: blend of glycerides at certain proportions; Other: glycerides used in current formulas

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 1 year (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Subjects who fulfil all of the following inclusion criteria will be included:

1. Evidence of personally signed and dated informed consent form indicating that the infant/toddler's parent(s)/ Legally Authorized representative (LAR) has been informed of all pertinent aspects of the study.
2. Infants/toddlers whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the study protocol.

3. Infants/toddlers must meet the following inclusion criteria respectively to be eligible for enrollment into the study:

   1. Healthy normally developing infant/toddler at the discretion of the investigator.
   2. Healthy term infant (37-42 weeks of gestation) at birth.
   3. At enrollment visit, post-natal age 2-3 months (60-90 days) for infants or 13-14 months for toddlers (date of birth = day 0).
   4. For the infant group, infants must have been exclusively consuming and tolerating a cow's milk infant formula not containing DHA for the past month, and their parent(s)/LAR must have independently elected, before enrolment, not to breastfeed.
   5. For the toddler group, toddlers must have been consuming and tolerating a cow's milk TMS not containing DHA for the past month.
   6. Infants or toddlers must not have been consuming DHA-containing supplements for the past month.

Exclusion Criteria:

Any of the following criteria would render a subject ineligible for inclusion:

1. Infants/toddlers with conditions requiring feedings other than those specified in the protocol.
2. Infants receiving complementary foods or liquids defined as 4 or more teaspoons per day or approximately 20 grams (g) per day of complementary foods or liquids at enrollment.

3. Infants/toddlers who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results, including:

   1. Evidence of major congenital malformations (e.g., cleft palate, extremity malformation).
   2. Suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis).
   3. Evidence of significant cardiac, respiratory, endocrinologic, hematologic, gastrointestinal (e.g., complicated gastroesophageal reflux combined with inadequate growth and/or respiratory complications, Hirschsprung's disease), or other systemic diseases.
   4. History of admission to the Neonatal Intensive Care Unit, with the exception of admission for jaundice phototherapy.
   5. Currently participating or having participated in another clinical trial since birth.
   6. Other severe medical or laboratory abnormality (acute or chronic) which, in the judgment of the investigator, would make the infant/toddler inappropriate for entry into the study.
4. Infants/toddlers who are presently receiving or have received prior to enrollment any of the following: medication(s) or supplement(s) which are known or suspected to affect fat digestion, absorption, and/or metabolism (e.g., lactase enzymes, pancreatic enzymes); medications that may neutralize or suppress gastric acid secretion; medications that could affect any study outcomes.
5. Infants/toddlers whose parent(s)/LAR who in the Investigator's assessment cannot be expected to comply with the protocol or with study procedures.

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
Experimental: EXPL; Liquid oral supplement comprising a blend of glycerides at certain proportions	Other: blend of glycerides at certain proportions; combination of glycerides in specific proportions in a liquid oral supplement
Other: CTRL; Liquid oral supplement comprising glycerides used in current formulas	Other: glycerides used in current formulas; glycerides used in current formulas in a liquid oral supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RBC-DHA levels after 56 days of supplementation	Red blood cell (RBC)-DHA after eight weeks of intervention	Study day 56

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RBC, plasma additional fatty acids status	Determination of omega-3, omega-6, eicosapentanoic acid, arachidonic acid	Study days 0, 14, 28 and 56
DHA supplement intake	Parent-reported supplement intake assessed using a 3-day DHA Supplement Intake and Tolerance Diary	Study days 3, 14, 28 and 56
Gastrointestinal (GI) tolerance	Parent-reported GI tolerance indicators assessed using a 3-day DHA Supplement Intake and Tolerance Diary	Study days 3, 14, 28 and 56
Weight	Weight measured in grams	Study days 0, 14, 28 and 56
Length	Length measured in cm	Study days 0, 14, 28 and 56
Head circumference	Head circumference measured in cm	Study days 0, 14, 28 and 56
Dietary intakes of DHA and other fatty acids (toddler population only)	Assessed using a 24-hour food recall	Study days 0, 28 and 56
Standard adverse events (AEs) and serious AEs (SAEs) reporting for safety assessment	Incidence of AEs / SAEs reported throughout the study, particular attention will be paid to AEs related to GI tolerance and comfort	Study days 0, 14, 28, 56, and 70

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Investigators: Principal Investigator: Elvira M Estorninos, MD, Las Pinas Doctors Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: January 4, 2022
• First Submitted That Met QC Criteria: March 3, 2022
• First Posted (Actual): March 4, 2022

Study Record Updates

• Last Update Posted (Actual): July 18, 2022
• Last Update Submitted That Met QC Criteria: July 14, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 18.20.NRC

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