NCT00571948

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 12, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
6.9 years until next milestone

Results Posted

Study results publicly available

January 9, 2015

Completed
Last Updated

May 21, 2015

Status Verified

May 1, 2015

Enrollment Period

1.8 years

First QC Date

December 11, 2007

Results QC Date

May 1, 2009

Last Update Submit

May 4, 2015

Conditions

Iron StatusFatty Acid Status

Keywords

infant, complementary food, iron, meat, LC-PUFA, omega-3,rapeseed oil, diet

Outcome Measures

Primary Outcomes (2)

  • 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

  • Parameters of Iron Status in Blood

    at the end of the fourth, seventh, tenth month of life

Secondary Outcomes (1)

  • 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

Study Arms (2)

Babyfood with usual meat content and corn oil

ACTIVE COMPARATOR

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 acidsOther: Babyfood with usual meat content and corn oil

more meat and a vegetable oil rich in omega-3 fatty acids

EXPERIMENTAL

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 acidsOther: Babyfood with usual meat content and corn oil

Interventions

more meat and a vegetable oil rich in omega-3 fatty acidsOTHER

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 oilmore meat and a vegetable oil rich in omega-3 fatty acids
Babyfood with usual meat content and corn oilOTHER

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

Babyfood with usual meat content and corn oilmore meat and a vegetable oil rich in omega-3 fatty acids

Eligibility Criteria

Age1 Week - 8 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • preterm infants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Institute of Child Nutrition

Dortmund, Nord-Rhein-Westfalen, 44225, Germany

Location

Related Publications (5)

  • 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.

    PMID: 19193660RESULT

  • 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.

    PMID: 19935821RESULT

  • 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.

    PMID: 19851802RESULT

  • 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.

    PMID: 19618230RESULT

  • 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.

    PMID: 20627488DERIVED

MeSH Terms

Interventions

Fatty Acids, Omega-3Corn Oil

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOilsFats, UnsaturatedPlant OilsPlant PreparationsBiological ProductsComplex MixturesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Results Point of Contact

Title
Dortmund Intervention Trial for Optimization of Infant Nutrition
Organization
Research Institute of Child Nutrition
kersting@fke-do.de
0049 231 7922100

Study Officials

  • Mathilde Kersting, PD Dr.

    Research Institute of Child Nutrition

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2007

First Posted

December 12, 2007

Study Start

September 1, 2005

Primary Completion

July 1, 2007

Study Completion

March 1, 2008

Last Updated

May 21, 2015

Results First Posted

January 9, 2015

Record last verified: 2015-05

Locations

DE(1)