Investigations on Improving Docosahexaenoic and Arachidonic Acid Content in Preterm Infant Formula

NCT ID: NCT01300130

Last Updated: 2011-02-21

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

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-06-30

Study Completion Date

1998-03-31

Brief Summary

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The investigators examined the effect of different levels of docosahexaenoic aicd (a long chain polyunsaturated fatty acid) intake on the fatty acid composition of plasma and erythrocyte phospholipids and on the maturity of visually evoked potentials in preterm infants. As a secondary outcome the conversion of linoleic acid and alpha linolenic acid into their corresponding long chain polyunsaturated fatty acids was studied.

Preterm infants were randomized in a double-blind fashion to one of three formulas containing different amounts of docosahexaenoic acid during the first two weeks of postnatal life. A control group received human milk. Blood samples were collected at study entry and 14 and 28 days thereafter. Uniformly 13C-labeled linoleic acid and alpha linolenic acid were applied orally before blood sampling at day 28. At postconceptional ages 48 weeks and 56 weeks visually evoked potentials were recorded.

Detailed Description

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Conditions

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Prematurity of Fetus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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low docosahexaenoic acid formula

Group Type EXPERIMENTAL

low docosahexaenoic acid formula

Intervention Type DIETARY_SUPPLEMENT

medium docosahexaenoic acid formula

Group Type EXPERIMENTAL

medium docosahexaenoic acid formula

Intervention Type DIETARY_SUPPLEMENT

high docosahexaenoic acid formula

Group Type EXPERIMENTAL

high docosahexaenoic acid formula

Intervention Type DIETARY_SUPPLEMENT

human milk

Group Type ACTIVE_COMPARATOR

breast milk

Intervention Type DIETARY_SUPPLEMENT

a non randomized group of breast milk fed infants was included

Interventions

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low docosahexaenoic acid formula

Intervention Type DIETARY_SUPPLEMENT

medium docosahexaenoic acid formula

Intervention Type DIETARY_SUPPLEMENT

high docosahexaenoic acid formula

Intervention Type DIETARY_SUPPLEMENT

breast milk

a non randomized group of breast milk fed infants was included

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* preterm birth
* birth weight between 1000 and 2200 g
* more than 80 % of energy intake from infant formula or human milk at enrollment

Exclusion Criteria

* apparent genetic, gastrointestinal or metabolic disorders
* artificial ventilation or oxygen supply \> 30% at the time of enrollment
* administration of parenteral fat emulsion (\> 1 g/kg/day for more than seven days) before or after study entry
Maximum Eligible Age

14 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role collaborator

German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role collaborator

German Research Foundation

OTHER

Sponsor Role collaborator

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Ludwig-Maximilians - University of Munich

Principal Investigators

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Berthold Koletzko, Prof.

Role: PRINCIPAL_INVESTIGATOR

Ludwig-Maximilians - University of Munich

Locations

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Children´s Hospital, Zentralklinikum Augsburg

Augsburg, , Germany

Site Status

Josephinum Hospital

Augsburg, , Germany

Site Status

I. Frauenklinik of the Ludwig-Maximilians-University

München, , Germany

Site Status

Lachnerklinik

München, , Germany

Site Status

University Hospital Rechts der Isar

München, , Germany

Site Status

Countries

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Germany

References

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Sauerwald UC, Fink MM, Demmelmair H, Schoenaich PV, Rauh-Pfeiffer AA, Koletzko B. Effect of different levels of docosahexaenoic acid supply on fatty acid status and linoleic and alpha-linolenic acid conversion in preterm infants. J Pediatr Gastroenterol Nutr. 2012 Mar;54(3):353-63. doi: 10.1097/MPG.0b013e31823c3bfd.

Reference Type DERIVED
PMID: 22008957 (View on PubMed)

Other Identifiers

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45-95

Identifier Type: -

Identifier Source: org_study_id

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