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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Research Institute of Child Nutrition, Dortmund.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Research Institute of Child Nutrition, Dortmund
ClinicalTrials.gov Identifier:
NCT00571948
First received: December 11, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted

December 11, 2007
December 11, 2007
September 2005
Not Provided
parameters of iron status in blood, fatty acid pattern in plasma [ Time Frame: at the end of the fourth, seventh, tenth month of life ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Modification in Complementary Food Composition to Improve the Status of Iron and Fatty Acids in Infants.
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).
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Iron Status
  • Fatty Acid Status
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).
  • No Intervention: 0
    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.
    Intervention: Other: more meat and a vegetable oil rich in omega-3 fatty acids
  • Experimental: 1
    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.
    Intervention: Other: more meat and a vegetable oil rich in omega-3 fatty acids

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
132
March 2008
Not Provided

Inclusion Criteria:

  • a term healthy newborn infant (birth weight > 2500 g, gestational age > 37 weeks);
  • 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
Both
up to 8 Weeks
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00571948
2XIKers
No
PD Dr. M. Kersting, Research Institute of Child Nutrition, Dortmund
Research Institute of Child Nutrition, Dortmund
Not Provided
Principal Investigator: Mathilde Kersting, PD Dr. Research Institute of Child Nutrition
Research Institute of Child Nutrition, Dortmund
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP