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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00631046
Other study ID # H-A-2007-0088
Secondary ID D203
Status Completed
Phase N/A
First received February 28, 2008
Last updated July 14, 2009
Start date February 2008
Est. completion date May 2009

Study information

Verified date July 2009
Source University of Copenhagen
Contact n/a
Is FDA regulated No
Health authority Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date May 2009
Est. primary completion date May 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 8 Months to 19 Months
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Intervention

Dietary Supplement:
Fish Oil
Daily dosage of 5 ml of fish oils from 9 months +/- 2weeks to 18 months +/- 4 weeks of age
Sunflower Oil
Daily dosage of 5 ml of sunflower oil from 9 months +/- 2weeks to 18 months +/- 4 weeks of age

Locations

Country Name City State
Denmark Dept. of Human Nutrition Copenhagen Frederiksberg C

Sponsors (2)

Lead Sponsor Collaborator
University of Copenhagen Axellus

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Growth
Primary Body composition
Primary Intestinal microbiota
Primary Blood pressure
Primary Plasma lipid profile
Primary Insulin - glucose
Primary Erythrocyte fatty acid composition
Primary Ex vivo cytokine production
Primary IGF-1 and IGFBP-3
Primary Adipokines
Primary Plasma CRP
Primary Plasma IgE
Secondary Glucagon
Secondary Metagenome analysis (investigating the enzymatic capacity of the intestines through prokaryotic DNA sequencing)
Secondary Iron status (hemoglobin, ferritin)
Secondary faecal calprotectin
Secondary FADS1 and FADS2 genotypes
Secondary Allergy status
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