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Completed

NCT Number: NCT00571948

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

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.

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Key information

Age range

1 week–8 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Institute of Child Nutrition

Dortmund, Nord-Rhein-Westfalen, 44225, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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).

Babyfood with usual meat content and corn oil

Other

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

Primary outcomes

  1. Sum of Omega-3 Fatty Acid Pattern in Plasma

    Time frame: at the end of the tenth month of life

    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).

  2. Parameters of Iron Status in Blood

    Time frame: at the end of the fourth, seventh, tenth month of life

Secondary outcomes

  1. Dietary Intake; Anthropometric Measures: Body Weight, Body Lengths, Head Circumferences

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Research Institute of Child Nutrition, Dortmund

Other

Registry information

Official study title

Dortmund Intervention Trial for Optimization of Infant Nutrition

Acronym: DINO

Important dates

Study start
2005
Primary completion
2007
Study completion
2008
First posted
Dec 12, 2007
Registry last updated
May 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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