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
  Purpose

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
Iron Status
Fatty Acid Status
Other: more meat and a vegetable oil rich in omega-3 fatty acids

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Dortmund Intervention Trial for Optimization of Infant Nutrition

Resource links provided by NLM:


Further study details as provided by Research Institute of Child Nutrition, Dortmund:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 132
Study Start Date: September 2005
Estimated Study Completion Date: March 2008
Arms Assigned Interventions
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.
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).

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.
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).


Detailed 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).

  Eligibility

Ages Eligible for Study:   up to 8 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00571948

Locations
Germany
Research Institute of Child Nutrition
Dortmund, Nord-Rhein-Westfalen, Germany, 44225
Sponsors and Collaborators
Research Institute of Child Nutrition, Dortmund
Investigators
Principal Investigator: Mathilde Kersting, PD Dr. Research Institute of Child Nutrition
  More Information

No publications provided by Research Institute of Child Nutrition, Dortmund

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PD Dr. M. Kersting, Research Institute of Child Nutrition, Dortmund
ClinicalTrials.gov Identifier: NCT00571948     History of Changes
Other Study ID Numbers: 2XIKers
Study First Received: December 11, 2007
Last Updated: December 11, 2007
Health Authority: Germany: Ethics Commission

Keywords provided by Research Institute of Child Nutrition, Dortmund:
infant, complementary food, iron, meat, LC-PUFA, omega-3,
rapeseed oil, diet

ClinicalTrials.gov processed this record on July 29, 2014