Clinical trial NCT03014115: Effects of Different ARA Formulations of Infant Formula on Fatty Acid Status, Immune Markers and Infection Rates in Infants
Official title: EFFECTS OF DIFFERENT ARA FORMULATIONS OF INFANT FORMULA ON FATTY ACID STATUS, IMMUNE MARKERS AND INFECTION RATES IN INFANTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Infants
Keywords: arachidonic
docosahexaenoic acid
infant formula
Lead sponsor: DSM Nutritional Products, Inc.
Sponsor class: INDUSTRY
Collaborators: name: SynteractHCR
First posted: 2017-01-09
Enrollment: 110
Sex: ALL
Minimum age (years): 22
Maximum age (years): 26
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The clinical trial will investigate the effect of different formulations of ARA + 0.4% DHA in infant formula on plasma fatty acid status in healthy 6 months old infants supplemented for 6 months. A 6-month follow on phase will provide additional efficacy (e.g. infection rates, immune markers) and safety information in these 12-18 month old infants.

Detailed description: This study is a randomized, double-blind, parallel-group study of 0% ARA +0.4% DHA or 0.76% ARA +0.4% DHA supplemented infant formula provided to 6 months old healthy infants for 6 months. Infants will have been breast-fed or formula-fed prior to enrollment. The difference in total plasma fatty acid ARA levels between the two groups at 6 months of supplementation will be measured. Parents will be asked about the infant's current daily diet (fatty acid intakes calculated via 24 hour recalls). All completed infants will be enrolled into a 6 month extension period (non-supplemented) to collect additional measures of efficacy (i.e. infections and illnesses, immune markers) and safety out to 18 months of age.

Eligibility criteria: Inclusion Criteria:

* singleton infants,
* parent of legal age to consent,
* willing to feed the child the assigned study formula for the treatment duration,
* parent agrees to scheduled blood draws

Exclusion Criteria:

* exclusively breastfed or formula-fed beyond 6 months,
* difficulty swallowing or other congenital malformation or metabolic anomaly,
* taking omega-3 (supplemented) foods,
* mother had gestational diabetes or is Type II diabetic,
* born at \<37 weeks gestational age,
* participating in another study

Primary outcomes:
measure: total plasma fatty acid ARA levels
timeFrame: 6 months of supplementation
Secondary outcomes:
measure: incidence of infections
timeFrame: 6 months of supplementation
measure: weight gain
timeFrame: 6 months of supplementation
measure: length gain
timeFrame: 6 months of supplementation
measure: head circumference
timeFrame: 6 months of supplementation
measure: dietary intake of ARA
timeFrame: 6 months of supplementation
measure: plasma levels of immune markers
timeFrame: 6 months of supplementation
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Centro de Salud Aravaca
city: Madrid
country: Spain
facility: Centro Salud Arganda del Rey
Study officials:
affiliation: Instituto de Ciencia y Tecnología de Alimentos y Nutrición
name: Ascension Marcos, PhD
role: PRINCIPAL_INVESTIGATOR
References: