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Milk Types and Fish Oil in 9- to 12-Month-Old Infants

NCT ID: NCT00379171

Last Updated: 2008-08-14

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2004-03-31

Brief Summary

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The objective of this intervention study is to examine the effect of whole cow's milk versus infant formula as primary milk sources with or without supplements of n-3 LCPUFA for growth, nutritional status, development, risk factors for later diseases and the impact on the intestinal microbiota and inflammation in 9 - 12 months old infants.

Detailed Description

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Conditions

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Obesity Metabolic Syndrome Growth Blood Pressure Cardiovascular Disease

Keywords

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Children Complementary feeding Breast feeding Cow's milk Formula Protein LCPUFA Fish oil Lipid profile Intestinal inflammation Intestinal microbiota

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Interventions

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Cow's milk with fish oil

Intervention Type BEHAVIORAL

Cow's milk without fish oil

Intervention Type BEHAVIORAL

Formula with fish oil

Intervention Type BEHAVIORAL

Formula without fish oil

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Singleton infants
* Born \>= 37 wk of gestation
* Birth weight \> 2500g
* \>= 5th percentile for gestational age
* A 5-min Apgar score \>= 7
* Daily consumption of cow's milk or formula

Exclusion Criteria

* No major complications at birth or in fetal life
* No chronic diseases
Minimum Eligible Age

8 Months

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Anjo A/S

UNKNOWN

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role lead

Principal Investigators

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Kim F Michaelsen, Dr Med Sci

Role: STUDY_CHAIR

Institute of Human Nutrition, Rolighedsvej 30, DK-1958 Frederiksberg C, Denmark

References

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Lauritzen L, Christensen JH, Damsgaard CT, Michaelsen KF. The effect of fish oil supplementation on heart rate in healthy Danish infants. Pediatr Res. 2008 Dec;64(6):610-4. doi: 10.1203/PDR.0b013e318186e5c5.

Reference Type RESULT
PMID: 18679165 (View on PubMed)

Nielsen S, Nielsen DS, Lauritzen L, Jakobsen M, Michaelsen KF. Impact of diet on the intestinal microbiota in 10-month-old infants. J Pediatr Gastroenterol Nutr. 2007 May;44(5):613-8. doi: 10.1097/MPG.0b013e3180406a11.

Reference Type RESULT
PMID: 17460496 (View on PubMed)

Damsgaard CT, Lauritzen L, Kjaer TM, Holm PM, Fruekilde MB, Michaelsen KF, Frokiaer H. Fish oil supplementation modulates immune function in healthy infants. J Nutr. 2007 Apr;137(4):1031-6. doi: 10.1093/jn/137.4.1031.

Reference Type RESULT
PMID: 17374672 (View on PubMed)

Damsgaard CT, Schack-Nielsen L, Michaelsen KF, Fruekilde MB, Hels O, Lauritzen L. Fish oil affects blood pressure and the plasma lipid profile in healthy Danish infants. J Nutr. 2006 Jan;136(1):94-9. doi: 10.1093/jn/136.1.94.

Reference Type RESULT
PMID: 16365065 (View on PubMed)

Related Links

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http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Citation&list_uids=16365065

Damsgaard CT, Schack-Nielsen L, Michaelsen KF, Fruekilde MB, Hels O, Lauritzen L. Fish oil affects blood pressure and the plasma lipid profile in healthy danish infants. J Nutr 2006;136:94-9.

Other Identifiers

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D-74

Identifier Type: -

Identifier Source: secondary_id

KF 02-014/03

Identifier Type: -

Identifier Source: org_study_id