NCT01300130

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Ludwig-Maximilians - University of Munich · Academic / Other
• Sex: All
• Age: 14 Days
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 1995-06-01
• Primary completion: 1998-03-01
• Completion: 1998-03-01
• First posted: 2011-02-21
• Last updated: 2011-02-21

Locations

5 sites across 1 country: Germany