Essential Fatty Acids During Complementary Feeding (EFiON)

July 14, 2009 updated by: University of Copenhagen

The Importance of Increasing Intake of Essential Fatty Acids During Complementary Feeding on Infant Growth and Body Composition, Intestinal Health, Immune Function and Risk Markers for Later Metabolic Complications.

The objective of this intervention study is to examine the effect of n-3 LCPUFA on growth and body composition, intestinal health and microbiotic composition, immune function and risk markers for later diseases in 9-18 months old infants and toddlers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Frederiksberg C
      • Copenhagen, Frederiksberg C, Denmark, DK-1958
        • Dept. of Human Nutrition

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 months to 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Singleton infants, 9 mo +/- 2 wk, born >= 37 wk of gestation
  • Birth weight >=2500g, a 5-min Apgar score >= 7, birth weight >= 5th percentile for gestational age

Exclusion Criteria:

  • Chronic diseases expected to influence growth and dietary intake
  • Use of medicine expected to influence growth and dietary intake
  • Fish oil supplementation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fish Oil
containing n-3 LCPUFA
Dietary supplement: Fish Oil
Daily dosage of 5 ml of fish oils from 9 months +/- 2weeks to 18 months +/- 4 weeks of age
Placebo Comparator: Sunflower oil
containing n-6 PUFA
Dietary supplement: Sunflower Oil
Daily dosage of 5 ml of sunflower oil from 9 months +/- 2weeks to 18 months +/- 4 weeks of age

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Growth
Erythrocyte fatty acid composition
Blood pressure
Body composition
Plasma IgE
Intestinal microbiota
Plasma lipid profile
Insulin - glucose
Ex vivo cytokine production
IGF-1 and IGFBP-3
Adipokines
Plasma CRP

Secondary Outcome Measures

Outcome Measure
Allergy status
Glucagon
Metagenome analysis (investigating the enzymatic capacity of the intestines through prokaryotic DNA sequencing)
Iron status (hemoglobin, ferritin)
faecal calprotectin
FADS1 and FADS2 genotypes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

Axellus

Investigators

  • Principal Investigator: Kim F Michaelsen, Dr Med Sci, Dept. of Human Nutrition, LIFE, Univ. of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

February 28, 2008

First Submitted That Met QC Criteria

March 6, 2008

First Posted (Estimate)

March 7, 2008

Study Record Updates

Last Update Posted (Estimate)

July 15, 2009

Last Update Submitted That Met QC Criteria

July 14, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-A-2007-0088
  • D203

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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