Modification in Complementary Food Composition to Improve the Status of Iron and Fatty Acids in Infants. (DINO)
Recruitment status was Active, not recruiting
|First Received Date ICMJE||December 11, 2007|
|Last Updated Date||December 11, 2007|
|Start Date ICMJE||September 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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 ]|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE
||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 ]|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Modification in Complementary Food Composition to Improve the Status of Iron and Fatty Acids in Infants.|
|Official Title ICMJE||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).
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Intervention ICMJE||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).
|Study Arm (s)||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Estimated Completion Date||March 2008|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||up to 8 Weeks|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Germany|
|NCT Number ICMJE||NCT00571948|
|Other Study ID Numbers ICMJE||2XIKers|
|Has Data Monitoring Committee||No|
|Responsible Party||PD Dr. M. Kersting, Research Institute of Child Nutrition, Dortmund|
|Study Sponsor ICMJE||Research Institute of Child Nutrition, Dortmund|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Research Institute of Child Nutrition, Dortmund|
|Verification Date||December 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP