DHA Proof-of-Concept Study in Infants and Toddlers

NCT05266677 | Withdrawn

• 1 other identifier: 18.20.NRC
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• RBC-DHA levels after 56 days of supplementation

  Red blood cell (RBC)-DHA after eight weeks of intervention

  Study day 56

Secondary Outcomes (8)

• RBC, plasma additional fatty acids status

  Study days 0, 14, 28 and 56

• DHA supplement intake

  Study days 3, 14, 28 and 56

• Gastrointestinal (GI) tolerance

  Study days 3, 14, 28 and 56

• Weight

  Study days 0, 14, 28 and 56

• Length

  Study days 0, 14, 28 and 56

Study Arms (2)

EXPL

EXPERIMENTAL

Liquid oral supplement comprising a blend of glycerides at certain proportions

Other: blend of glycerides at certain proportions

CTRL

OTHER

Liquid oral supplement comprising glycerides used in current formulas

Other: glycerides used in current formulas

Interventions

blend of glycerides at certain proportions OTHER

combination of glycerides in specific proportions in a liquid oral supplement

EXPL

glycerides used in current formulas OTHER

glycerides used in current formulas in a liquid oral supplement

CTRL

Eligibility Criteria

• Age: 2 Months - 14 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Infants/toddlers whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the study protocol.
• Healthy normally developing infant/toddler at the discretion of the investigator.
• Healthy term infant (37-42 weeks of gestation) at birth.
• 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).
• 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.
• For the toddler group, toddlers must have been consuming and tolerating a cow's milk TMS not containing DHA for the past month.
• Infants or toddlers must not have been consuming DHA-containing supplements for the past month.

You may not qualify if:

• Infants/toddlers with conditions requiring feedings other than those specified in the protocol.
• 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.
• 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:
• Evidence of major congenital malformations (e.g., cleft palate, extremity malformation).
• Suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis).
• 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.
• History of admission to the Neonatal Intensive Care Unit, with the exception of admission for jaundice phototherapy.
• Currently participating or having participated in another clinical trial since birth.
• 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.
• 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.
• Infants/toddlers whose parent(s)/LAR who in the Investigator's assessment cannot be expected to comply with the protocol or with study procedures.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Officials

• Elvira M Estorninos, MD

  Las Pinas Doctors Hospital

  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

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: March 4, 2022
• Study Start: July 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: May 1, 2023
• Last Updated: July 18, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share