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Sponsored by: |
Research Institute of Child Nutrition, Dortmund |
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Information provided by: | Research Institute of Child Nutrition, Dortmund |
ClinicalTrials.gov Identifier: | NCT00571948 |
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.
Condition | Intervention |
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Iron Status Fatty Acid Status |
Other: more meat and a vegetable oil rich in omega-3 fatty acids |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Dortmund Intervention Trial for Optimization of Infant Nutrition |
Enrollment: | 132 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | March 2008 |
Arms | Assigned Interventions |
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0: No Intervention
Infants in the control group received vegetable-potato-meat-meals as part of complementary food containing common amounts of meat and corn oil marketed in Germany.
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Other: more meat and a vegetable oil rich in omega-3 fatty acids
The vegetable-potato-meat-meal was given 5 to 7 times a week for at least during the seventh to tenth month. The control meals contained little meat (about 8 % of weight) and corn oil (rich in omega-6 fatty acids) while the intervention meals had more meat (about 13 % of weight) and rapeseed oil (rich in omega-3 fatty acids). |
1: Experimental
Infants in the intervention group received vegetable-potato-meat-meals as part of complementary food containing higher amounts of meat than the control group and rapeseed oil instead of corn oil.
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Other: more meat and a vegetable oil rich in omega-3 fatty acids
The vegetable-potato-meat-meal was given 5 to 7 times a week for at least during the seventh to tenth month. The control meals contained little meat (about 8 % of weight) and corn oil (rich in omega-6 fatty acids) while the intervention meals had more meat (about 13 % of weight) and rapeseed oil (rich in omega-3 fatty acids). |
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).
Ages Eligible for Study: | up to 8 Weeks |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Germany, Nord-Rhein-Westfalen | |
Research Institute of Child Nutrition | |
Dortmund, Nord-Rhein-Westfalen, Germany, 44225 |
Principal Investigator: | Mathilde Kersting, PD Dr. | Research Institute of Child Nutrition |
Responsible Party: | Research Institute of Child Nutrition, Dortmund ( PD Dr. M. Kersting ) |
Study ID Numbers: | 2XIKers |
Study First Received: | December 11, 2007 |
Last Updated: | December 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00571948 |
Health Authority: | Germany: Ethics Commission |
infant, complementary food, iron, meat, LC-PUFA, omega-3, rapeseed oil, diet |
Iron |