Iron Status Clinical Trial
Official title:
Dortmund Intervention Trial for Optimization of Infant Nutrition
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.
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).
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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