Effects of Different ARA Formulations of Infant Formula on Fatty Acid Status, Immune Markers and Infection Rates in Infants

DSM Nutritional Products

Status: Completed

Conditions: Healthy Infants

Treatments: Dietary Supplement: DHA; Dietary Supplement: combination ARA + DHA

Study type: Interventional

Funder types: Industry

Identifiers

NCT03014115

2015-1080

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 22 to 26 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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110 participants in 2 patient groups

combination ARA+ DHA

Active Comparator group

Description:

combination 0.76% ARA+ 0.4% DHA in infant formula per day

Treatment:

Dietary Supplement: combination ARA + DHA

DHA

Experimental group

Description:

0% ARA +0.4% DHA in infant formula per day

Treatment:

Dietary Supplement: DHA