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

Iron Status Clinical Trial

— DINO  

Official title:

Dortmund Intervention Trial for Optimization of Infant Nutrition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00571948
• Other study ID #: 2XIKers
• Status: Completed
• Phase: N/A
• First received: December 11, 2007
• Last updated: May 4, 2015
• Start date: September 2005
• Est. completion date: March 2008

Study information

• Verified date: May 2015
• Source: Research Institute of Child Nutrition, Dortmund
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: March 2008
• Est. primary completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 8 Weeks

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fatty Acid Status
• Iron Status

Intervention

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 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
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

Locations

Country	Name	City	State
Germany	Research Institute of Child Nutrition	Dortmund	Nord-Rhein-Westfalen

Sponsors (1)

Lead Sponsor	Collaborator
Research Institute of Child Nutrition, Dortmund

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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. Ep — View 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/s003 — View 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. — View 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 blinde — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sum of Omega-3 Fatty Acid Pattern in Plasma	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).	at the end of the tenth month of life	No
Primary	Parameters of Iron Status in Blood		at the end of the fourth, seventh, tenth month of life	No
Secondary	Dietary Intake; Anthropometric Measures: Body Weight, Body Lengths, Head Circumferences		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	No