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

Primary Purpose

Healthy Infants

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
combination ARA + DHA
DHA
Sponsored by
DSM Nutritional Products, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy Infants focused on measuring arachidonic, docosahexaenoic acid, infant formula

Eligibility Criteria

22 Weeks - 26 Weeks (Child)All SexesAccepts 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

Sites / Locations

  • Centro de Salud Aravaca
  • Centro Salud Arganda del Rey

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

combination ARA+ DHA

DHA

Arm Description

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

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

Outcomes

Primary Outcome Measures

total plasma fatty acid ARA levels
difference in total plasma fatty acid ARA levels between the two groups at 6 months of supplementation

Secondary Outcome Measures

incidence of infections
record number, type and duration of infections
weight gain
differences between groups in weight gain (kg/d)
length gain
differences between groups in length gain (cm/d)
head circumference
differences between groups in head circumference (cm/d)
dietary intake of ARA
24 hour recall questionnaire
plasma levels of immune markers
cytokines and T cells levels in plasma will be measured

Full Information

First Posted
January 3, 2017
Last Updated
January 14, 2020
Sponsor
DSM Nutritional Products, Inc.
Collaborators
SynteractHCR
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1. Study Identification

Unique Protocol Identification Number
NCT03014115
Brief Title
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
August 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DSM Nutritional Products, Inc.
Collaborators
SynteractHCR

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Infants
Keywords
arachidonic, docosahexaenoic acid, infant formula

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
combination ARA+ DHA
Arm Type
Active Comparator
Arm Description
combination 0.76% ARA+ 0.4% DHA in infant formula per day
Arm Title
DHA
Arm Type
Experimental
Arm Description
0% ARA +0.4% DHA in infant formula per day
Intervention Type
Dietary Supplement
Intervention Name(s)
combination ARA + DHA
Other Intervention Name(s)
infant formula
Intervention Description
combination ARA + DHA supplemented infant formula
Intervention Type
Dietary Supplement
Intervention Name(s)
DHA
Other Intervention Name(s)
infant formula
Intervention Description
DHA supplemented infant formula
Primary Outcome Measure Information:
Title
total plasma fatty acid ARA levels
Description
difference in total plasma fatty acid ARA levels between the two groups at 6 months of supplementation
Time Frame
6 months of supplementation
Secondary Outcome Measure Information:
Title
incidence of infections
Description
record number, type and duration of infections
Time Frame
6 months of supplementation
Title
weight gain
Description
differences between groups in weight gain (kg/d)
Time Frame
6 months of supplementation
Title
length gain
Description
differences between groups in length gain (cm/d)
Time Frame
6 months of supplementation
Title
head circumference
Description
differences between groups in head circumference (cm/d)
Time Frame
6 months of supplementation
Title
dietary intake of ARA
Description
24 hour recall questionnaire
Time Frame
6 months of supplementation
Title
plasma levels of immune markers
Description
cytokines and T cells levels in plasma will be measured
Time Frame
6 months of supplementation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Weeks
Maximum Age & Unit of Time
26 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ascension Marcos, PhD
Organizational Affiliation
Instituto de Ciencia y Tecnología de Alimentos y Nutrición
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Salud Aravaca
City
Madrid
Country
Spain
Facility Name
Centro Salud Arganda del Rey
City
Madrid
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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