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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2019-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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combination ARA+ DHA

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

Group Type ACTIVE_COMPARATOR

combination ARA + DHA

Intervention Type DIETARY_SUPPLEMENT

combination ARA + DHA supplemented infant formula

DHA

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

Group Type EXPERIMENTAL

DHA

Intervention Type DIETARY_SUPPLEMENT

DHA supplemented infant formula

Interventions

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combination ARA + DHA

combination ARA + DHA supplemented infant formula

Intervention Type DIETARY_SUPPLEMENT

DHA

DHA supplemented infant formula

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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infant formula infant formula

Eligibility Criteria

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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

Minimum Eligible Age

22 Weeks

Maximum Eligible Age

26 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes