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Completed

NCT Number: NCT01300130

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

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.

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Key information

Conditions

Prematurity of Fetus

Age range

Up to 14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children´s Hospital, Zentralklinikum Augsburg, Augsburg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

low docosahexaenoic acid formula

Dietary Supplement

medium docosahexaenoic acid formula

Dietary Supplement

high docosahexaenoic acid formula

Dietary Supplement

breast milk

Dietary Supplement

a non randomized group of breast milk fed infants was included

Primary outcomes

  1. plasma phospholipid fatty acid composition

    Time frame: 28 days after intervention start

  2. visually evoked potentials

    Time frame: 48 weeks and 56 weeks postconceptional age

Secondary outcomes

  1. intensity of endogenous conversion of essential fatty acids into long chain polyunsaturated fatty acids

    Time frame: 28 days after study start

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Collaborators

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

Registry information

Important dates

Study start
1995
Primary completion
1998
Study completion
1998
First posted
Feb 21, 2011
Registry last updated
Feb 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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