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

February 18, 2011 updated by: Ludwig-Maximilians - University of Munich

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

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

  • Germany
      • Augsburg, Germany
        • Children´s Hospital, Zentralklinikum Augsburg
      • Augsburg, Germany
        • Josephinum Hospital
      • München, Germany
        • I. Frauenklinik of the Ludwig-Maximilians-University
      • München, Germany
        • Lachnerklinik
      • München, Germany
        • University Hospital Rechts der Isar

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

No older than 2 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: low docosahexaenoic acid formula
Dietary supplement: low docosahexaenoic acid formula
Experimental: medium docosahexaenoic acid formula
Dietary supplement: medium docosahexaenoic acid formula
Experimental: high docosahexaenoic acid formula
Dietary supplement: high docosahexaenoic acid formula
Active Comparator: human milk
Dietary supplement: breast milk
a non randomized group of breast milk fed infants was included

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
plasma phospholipid fatty acid composition
Time Frame: 28 days after intervention start
28 days after intervention start
visually evoked potentials
Time Frame: 48 weeks and 56 weeks postconceptional age
48 weeks and 56 weeks postconceptional age

Secondary Outcome Measures

Outcome Measure
Time Frame
intensity of endogenous conversion of essential fatty acids into long chain polyunsaturated fatty acids
Time Frame: 28 days after study start
28 days after study start

Collaborators and Investigators

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

Sponsor

Ludwig-Maximilians - University of Munich

Collaborators

German Research Foundation
German Federal Ministry of Education and Research
Société des Produits Nestlé (SPN)

Investigators

  • Principal Investigator: Berthold Koletzko, Prof., Ludwig-Maximilians - University of Munich

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

June 1, 1995

Primary Completion (Actual)

March 1, 1998

Study Completion (Actual)

March 1, 1998

Study Registration Dates

First Submitted

February 18, 2011

First Submitted That Met QC Criteria

February 18, 2011

First Posted (Estimate)

February 21, 2011

Study Record Updates

Last Update Posted (Estimate)

February 21, 2011

Last Update Submitted That Met QC Criteria

February 18, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 45-95

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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