Clinical trial NCT00571948: Modification in Complementary Food Composition to Improve the Status of Iron and Fatty Acids in Infants.
Official title: Dortmund Intervention Trial for Optimization of Infant Nutrition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Status
Fatty Acid Status
Keywords: infant, complementary food, iron, meat, LC-PUFA, omega-3,
rapeseed oil, diet
Lead sponsor: Research Institute of Child Nutrition, Dortmund
Sponsor class: OTHER
First posted: 2007-12-12
Enrollment: 132
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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 criteria: 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

Primary outcomes:
measure: Sum of Omega-3 Fatty Acid Pattern in Plasma
timeFrame: at the end of the tenth month of life
measure: Parameters of Iron Status in Blood
timeFrame: at the end of the fourth, seventh, tenth month of life
Secondary outcomes:
measure: Dietary Intake; Anthropometric Measures: Body Weight, Body Lengths, Head Circumferences
timeFrame: 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
Other outcomes:
Locations:
city: Dortmund
country: Germany
facility: Research Institute of Child Nutrition
state: Nord-Rhein-Westfalen
Study officials:
affiliation: Research Institute of Child Nutrition
name: Mathilde Kersting, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schwartz J, Dube K, Sichert-Hellert W, Kannenberg F, Kunz C, Kalhoff H, Kersting M. Modification of dietary polyunsaturated fatty acids via complementary food enhances n-3 long-chain polyunsaturated fatty acid synthesis in healthy infants: a double blinded randomised controlled trial. Arch Dis Child. 2009 Nov;94(11):876-82. doi: 10.1136/adc.2008.146027. Epub 2009 Feb 4.
citation: Schwartz J, Dube K, Alexy U, Kalhoff H, Kersting M. PUFA and LC-PUFA intake during the first year of life: can dietary practice achieve a guideline diet? Eur J Clin Nutr. 2010 Feb;64(2):124-30. doi: 10.1038/ejcn.2009.123. Epub 2009 Nov 25.
citation: Schwartz J, Drossard C, Dube K, Kannenberg F, Kunz C, Kalhoff H, Kersting M. Dietary intake and plasma concentrations of PUFA and LC-PUFA in breastfed and formula fed infants under real-life conditions. Eur J Nutr. 2010 Apr;49(3):189-95. doi: 10.1007/s00394-009-0067-1. Epub 2009 Oct 23.
citation: Dube K, Schwartz J, Mueller MJ, Kalhoff H, Kersting M. Complementary food with low (8%) or high (12%) meat content as source of dietary iron: a double-blinded randomized controlled trial. Eur J Nutr. 2010 Feb;49(1):11-8. doi: 10.1007/s00394-009-0043-9. Epub 2009 Jul 19.
citation: Dube K, Schwartz J, Mueller MJ, Kalhoff H, Kersting M. Iron intake and iron status in breastfed infants during the first year of life. Clin Nutr. 2010 Dec;29(6):773-8. doi: 10.1016/j.clnu.2010.05.002. Epub 2010 Jun 2.