An interventional study of low docosahexaenoic acid formula and medium docosahexaenoic acid formula in Prematurity of Fetus, sponsored by Ludwig-Maximilians - University of Munich. Completed at 5 sites in Germany. Open to participants aged Up to 14 Days. Per ClinicalTrials.gov, last updated 2011-02-21.
Sponsored by Ludwig-Maximilians - University of Munich · Not applicable, Interventional, and Supportive care
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.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's enrollment of 66 is below the median of 84 across 1,689 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Ludwig-Maximilians - University of Munich is the lead sponsor of 218 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
plasma phospholipid fatty acid composition
Time frame: 28 days after intervention start
visually evoked potentials
Time frame: 48 weeks and 56 weeks postconceptional age
intensity of endogenous conversion of essential fatty acids into long chain polyunsaturated fatty acids
Time frame: 28 days after study start
This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ludwig-Maximilians - University of Munich