Status:
WITHDRAWN
DHA Proof-of-Concept Study in Infants and Toddlers
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Infants
Toddlers
Eligibility:
All Genders
2-14 years
Phase:
NA
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 gl...
Eligibility Criteria
Inclusion
- Subjects who fulfil all of the following inclusion criteria will be included:
- 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.
- Infants/toddlers must meet the following inclusion criteria respectively to be eligible for enrollment into the study:
- 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.
Exclusion
- Any of the following criteria would render a subject ineligible for inclusion:
- 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.
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05266677
Start Date
July 1 2022
End Date
May 1 2023
Last Update
July 18 2022
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