Clinical trial NCT05266677: DHA Proof-of-Concept Study in Infants and Toddlers
Official title: Effect of a Liquid Oral Supplement Comprising a Blend of Glycerides at Certain Proportions on Infant and Toddler DHA Status
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Infants
Toddlers
Nutritional Supplement
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2022-03-04
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: RBC-DHA levels after 56 days of supplementation
timeFrame: Study day 56
Secondary outcomes:
measure: RBC, plasma additional fatty acids status
timeFrame: Study days 0, 14, 28 and 56
measure: DHA supplement intake
timeFrame: Study days 3, 14, 28 and 56
measure: Gastrointestinal (GI) tolerance
timeFrame: Study days 3, 14, 28 and 56
measure: Weight
timeFrame: Study days 0, 14, 28 and 56
measure: Length
timeFrame: Study days 0, 14, 28 and 56
measure: Head circumference
timeFrame: Study days 0, 14, 28 and 56
measure: Dietary intakes of DHA and other fatty acids (toddler population only)
timeFrame: Study days 0, 28 and 56
measure: Standard adverse events (AEs) and serious AEs (SAEs) reporting for safety assessment
timeFrame: Study days 0, 14, 28, 56, and 70
Other outcomes:
Locations:
Study officials:
affiliation: Las Pinas Doctors Hospital
name: Elvira M Estorninos, MD
role: PRINCIPAL_INVESTIGATOR
References: