DHA Proof-of-Concept Study in Infants and Toddlers

NCT ID: NCT05266677

Last Updated: 2022-07-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-31
• Study Completion Date: 2023-05-31

Brief Summary

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.

Conditions

Infants; Toddlers; Nutritional Supplement

Study Design

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

Study Groups

EXPL

Liquid oral supplement comprising a blend of glycerides at certain proportions

Group Type: EXPERIMENTAL

blend of glycerides at certain proportions

Intervention Type: OTHER

combination of glycerides in specific proportions in a liquid oral supplement

CTRL

Liquid oral supplement comprising glycerides used in current formulas

Group Type: OTHER

glycerides used in current formulas

Intervention Type: OTHER

glycerides used in current formulas in a liquid oral supplement

Interventions

blend of glycerides at certain proportions

combination of glycerides in specific proportions in a liquid oral supplement

Intervention Type: OTHER

glycerides used in current formulas

glycerides used in current formulas in a liquid oral supplement

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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.

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.

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 14 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elvira M Estorninos, MD

Role: PRINCIPAL_INVESTIGATOR

Las Pinas Doctors Hospital

Other Identifiers

18.20.NRC

Identifier Type: -

Identifier Source: org_study_id