MedTrace Logo

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

NCT01300130 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2011-02-21

No results posted yet for this study

Summary

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.

Conditions

  • Prematurity of Fetus

Interventions

DIETARY_SUPPLEMENT

low docosahexaenoic acid formula

DIETARY_SUPPLEMENT

medium docosahexaenoic acid formula

DIETARY_SUPPLEMENT

high docosahexaenoic acid formula

DIETARY_SUPPLEMENT

breast milk

a non randomized group of breast milk fed infants was included

Sponsors & Collaborators

  • Société des Produits Nestlé (SPN)

    collaborator INDUSTRY

  • German Federal Ministry of Education and Research

    collaborator OTHER_GOV

  • German Research Foundation

    collaborator OTHER

  • Ludwig-Maximilians - University of Munich

    lead OTHER

Principal Investigators

  • Berthold Koletzko, Prof. · Ludwig-Maximilians - University of Munich

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
14 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1995-06-30
Primary Completion
1998-03-31
Completion
1998-03-31

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01300130 on ClinicalTrials.gov