NCT01300130

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 1995

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1995

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 1998

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 1998

Completed
13 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 21, 2011

Completed
Last Updated

February 21, 2011

Status Verified

February 1, 2011

Enrollment Period

2.8 years

First QC Date

February 18, 2011

Last Update Submit

February 18, 2011

Conditions

Prematurity of Fetus

Keywords

neurological developmentpreterm infantsfatty acid status

Outcome Measures

Primary Outcomes (2)

  • plasma phospholipid fatty acid composition

    28 days after intervention start

  • visually evoked potentials

    48 weeks and 56 weeks postconceptional age

Secondary Outcomes (1)

  • intensity of endogenous conversion of essential fatty acids into long chain polyunsaturated fatty acids

    28 days after study start

Study Arms (4)

low docosahexaenoic acid formula

EXPERIMENTAL
Dietary Supplement: low docosahexaenoic acid formula

medium docosahexaenoic acid formula

EXPERIMENTAL
Dietary Supplement: medium docosahexaenoic acid formula

high docosahexaenoic acid formula

EXPERIMENTAL
Dietary Supplement: high docosahexaenoic acid formula

human milk

ACTIVE COMPARATOR
Dietary Supplement: breast milk

Interventions

low docosahexaenoic acid formulaDIETARY_SUPPLEMENT
low docosahexaenoic acid formula
medium docosahexaenoic acid formulaDIETARY_SUPPLEMENT
medium docosahexaenoic acid formula
high docosahexaenoic acid formulaDIETARY_SUPPLEMENT
high docosahexaenoic acid formula
breast milkDIETARY_SUPPLEMENT

a non randomized group of breast milk fed infants was included

human milk

Eligibility Criteria

AgeUp to 14 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Children´s Hospital, Zentralklinikum Augsburg

Augsburg, Germany

Location

Josephinum Hospital

Augsburg, Germany

Location

I. Frauenklinik of the Ludwig-Maximilians-University

München, Germany

Location

Lachnerklinik

München, Germany

Location

University Hospital Rechts der Isar

München, Germany

Location

Related Publications (1)

  • 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.

    PMID: 22008957DERIVED

MeSH Terms

Interventions

Milk, Human

Intervention Hierarchy (Ancestors)

MilkBeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Study Officials

  • Berthold Koletzko, Prof.

    Ludwig-Maximilians - University of Munich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 18, 2011

First Posted

February 21, 2011

Study Start

June 1, 1995

Primary Completion

March 1, 1998

Study Completion

March 1, 1998

Last Updated

February 21, 2011

Record last verified: 2011-02

Locations

DE(5)