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

This study has been completed.
Sponsor:
Collaborators:
Nestlé Nutrition, Vevey, Switzerland
Nestlé Nutrition, Frankfurt/Main, Germany
German Federal Ministry of Education and Research
German Research Foundation
Information provided by:
Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT01300130
First received: February 18, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Prematurity of Fetus
 Dietary Supplement: low docosahexaenoic acid formula
Dietary Supplement: medium docosahexaenoic acid formula
Dietary Supplement: high docosahexaenoic acid formula
Dietary Supplement: breast milk

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Investigations on Improving Docosahexaenoic and Arachidonic Acid Content in Preterm Infant Formula

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • plasma phospholipid fatty acid composition [ Time Frame: 28 days after intervention start ] [ Designated as safety issue: No ]
  • visually evoked potentials [ Time Frame: 48 weeks and 56 weeks postconceptional age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • intensity of endogenous conversion of essential fatty acids into long chain polyunsaturated fatty acids [ Time Frame: 28 days after study start ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: June 1995
Study Completion Date: March 1998
Primary Completion Date: March 1998 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 14 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01300130

Locations
Germany
Children´s Hospital, Zentralklinikum Augsburg
Augsburg, Germany
Josephinum Hospital
Augsburg, Germany
I. Frauenklinik of the Ludwig-Maximilians-University
München, Germany
Lachnerklinik
München, Germany
University Hospital Rechts der Isar
München, Germany
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Nestlé Nutrition, Vevey, Switzerland
Nestlé Nutrition, Frankfurt/Main, Germany
German Federal Ministry of Education and Research
German Research Foundation
Investigators
Principal Investigator: Berthold Koletzko, Prof. Ludwig-Maximilians - University of Munich
  More Information

No publications provided by Ludwig-Maximilians - University of Munich

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT01300130     History of Changes
Other Study ID Numbers: 45-95
Study First Received: February 18, 2011
Last Updated: February 18, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Ludwig-Maximilians - University of Munich:
neurological development
preterm infants
fatty acid status

ClinicalTrials.gov processed this record on June 17, 2013