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Essential Fatty Acids During Complementary Feeding (EFiON)

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ClinicalTrials.gov Identifier: NCT00631046
Recruitment Status : Completed
First Posted : March 7, 2008
Last Update Posted : July 15, 2009
Sponsor:
Collaborator:
Axellus
Information provided by:
University of Copenhagen

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Growth Metabolic Syndrome Cardiovascular Disease Dietary Supplement: Fish Oil Dietary Supplement: Sunflower Oil Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: 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.
Study Start Date : February 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Fish oil
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Growth
  2. Body composition
  3. Intestinal microbiota
  4. Blood pressure
  5. Plasma lipid profile
  6. Insulin - glucose
  7. Erythrocyte fatty acid composition
  8. Ex vivo cytokine production
  9. IGF-1 and IGFBP-3
  10. Adipokines
  11. Plasma CRP
  12. Plasma IgE

Secondary Outcome Measures :
  1. Glucagon
  2. Metagenome analysis (investigating the enzymatic capacity of the intestines through prokaryotic DNA sequencing)
  3. Iron status (hemoglobin, ferritin)
  4. faecal calprotectin
  5. FADS1 and FADS2 genotypes
  6. Allergy status


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Ages Eligible for Study:   8 Months to 19 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00631046


Locations
Denmark
Dept. of Human Nutrition
Copenhagen, Frederiksberg C, Denmark, DK-1958
Sponsors and Collaborators
University of Copenhagen
Axellus
Investigators
Principal Investigator: Kim F Michaelsen, Dr Med Sci Dept. of Human Nutrition, LIFE, Univ. of Copenhagen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kim Fleischer Michaelsen, Dr Med Sci, Dept. of Human Nutrition, Rolighedsvej 30, DK-1958 Frederiksberg C, Denmark
ClinicalTrials.gov Identifier: NCT00631046     History of Changes
Other Study ID Numbers: H-A-2007-0088
D203
First Posted: March 7, 2008    Key Record Dates
Last Update Posted: July 15, 2009
Last Verified: July 2009

Keywords provided by University of Copenhagen:
n-3 LCPUFA
Fish oil
essential fatty acids
infant growth
obesity
Intestinal microbiota

Additional relevant MeSH terms:
Cardiovascular Diseases
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases