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

Research Institute of Child Nutrition, Dortmund

Status: Completed

Conditions: Iron Status; Fatty Acid Status

Treatments: Other: more meat and a vegetable oil rich in omega-3 fatty acids; Other: Babyfood with usual meat content and corn oil

Study type: Interventional

Funder types: Other

Identifiers

NCT00571948

2XIKers

Details and patient eligibility

About

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.

Full 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).

Enrollment: 132 patients

Sex: All

Ages: 1 to 8 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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132 participants in 2 patient groups

Babyfood with usual meat content and corn oil

Active Comparator group

Description:

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.

Treatment:

Other: Babyfood with usual meat content and corn oil

Other: more meat and a vegetable oil rich in omega-3 fatty acids

more meat and a vegetable oil rich in omega-3 fatty acids

Experimental group

Description:

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.

Treatment:

Other: Babyfood with usual meat content and corn oil

Other: more meat and a vegetable oil rich in omega-3 fatty acids