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Trials / Completed

CompletedNCT00571948

Modification in Complementary Food Composition to Improve the Status of Iron and Fatty Acids in Infants.

Dortmund Intervention Trial for Optimization of Infant Nutrition

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
132 (actual)
Sponsor
Research Institute of Child Nutrition, Dortmund · Academic / Other
Sex
All
Age
1 Week – 8 Weeks
Healthy volunteers
Accepted

Summary

The objective of this study is to determine the influence of an increase of meat in complementary food on iron status and the effect of an exchange of vegetable oil in the same food on the status of omega-3 fatty acids in infants in the second six months of life.

Detailed description

Because of rapid growth in the first year of life, infants are at a high risk to develop iron deficiency (ID) or even iron deficiency anaemia (IDA). Iron metabolism in infancy seems to be immature and to be affected by developmental changes and is not yet fully understood. Therefore studies with both, detailed dietary intake and a full set of biomarkers to characterize iron status or the risk of IDA are welcome. LC-PUFA, especially docosahexaenoic acid (DHA, n-3), are of important meaning in infants´ neural development because neural tissues have a unique pattern of FA. DHA is predominantly found in brain and retina. LC-PUFA can be either supplied preformed by diet or converted from their essential precursors the polyunsaturated fatty acids (PUFA) linoleic acid (LA, n-6) and α-linolenic acid (ALA, n-3) by the organism dependent on the ratio of n-6/n-3 FA in the diet. In the case of iron as well as of PUFA and LC-PUFA very little is known about the nutritional supply and its effect on status in the second half of the first year of life. Therefore the objective of DINO is to examine the feasibility of increasing meat and of exchanging n-6 rich corn oil vs. n-3 rich rapeseed oil in common commercial menus and to examine the effects on iron status and on blood FA pattern respectively as primary outcome variables in a double-blinded randomized controlled intervention trial (RCT).

Conditions

Interventions

TypeNameDescription
OTHERmore meat and a vegetable oil rich in omega-3 fatty acidsThe vegetable-potato-meat-meal was given 5 to 7 times a week for at least during the seventh to tenth month. The intervention meals had more meat (about 13 % of weight) and rapeseed oil (rich in omega-3 fatty acids).
OTHERBabyfood with usual meat content and corn oilThe active comparator (which is the control group) got babyfood with usual meat content (8%) and with corn oil, which is rich in omega 6 linoleic acid

Timeline

Start date
2005-09-01
Primary completion
2007-07-01
Completion
2008-03-01
First posted
2007-12-12
Last updated
2015-05-21
Results posted
2015-01-09

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT00571948. Inclusion in this directory is not an endorsement.