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

Study Overview
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Brief Summary
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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
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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).

Official Title
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Dortmund Intervention Trial for Optimization of Infant Nutrition

Conditions
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Iron Status, Fatty Acid Status

Intervention / Treatment
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* Other: more meat and a vegetable oil rich in omega-3 fatty acids
* Other: Babyfood with usual meat content and corn oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a term healthy newborn infant (birth weight > 2500 g, gestational age > 37 weeks); inclusion during the first two months of life. German speaking mother; the intention of the mother to breast-feed the child and to feed study menus 5 to 7 times per week beginning in the fifth to seventh month of life. Exclusion Criteria: preterm infants

Ages Eligible for Study
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Minimum Age: 1 Week
Maximum Age: 8 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Babyfood with usual meat content and corn oil<br>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. | Other: more meat and a vegetable oil rich in omega-3 fatty acids<br>* The 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).<br>Other: Babyfood with usual meat content and corn oil<br>* The 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<br>|
| Experimental: more meat and a vegetable oil rich in omega-3 fatty acids<br>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. | Other: more meat and a vegetable oil rich in omega-3 fatty acids<br>* The 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).<br>Other: Babyfood with usual meat content and corn oil<br>* The 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sum of Omega-3 Fatty Acid Pattern in Plasma | fatty acids were measured in the whole plasma (in mg). They were transformed into percent (%) per total fatty acids. Results are shown as percent (%) per total fatty acids before and after the intervention as median (percentile 25th;75th). | at the end of the tenth month of life | 
| Parameters of Iron Status in Blood |  | at the end of the fourth, seventh, tenth month of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary Intake; Anthropometric Measures: Body Weight, Body Lengths, Head Circumferences |  | dietary intake: from the beginning of the third month of life to the end of the tenth month; anthropometric measures: at the end of the fourth, seventh, tenth month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infant, complementary food, iron, meat, LC-PUFA, omega-3,, rapeseed oil, diet