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

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ClinicalTrials.gov Identifier: NCT00571948
Recruitment Status : Completed
First Posted : December 12, 2007
Results First Posted : January 9, 2015
Last Update Posted : May 21, 2015
Sponsor:
Information provided by (Responsible Party):
Research Institute of Child Nutrition, Dortmund

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Iron Status
Fatty Acid Status
Interventions Other: more meat and a vegetable oil rich in omega-3 fatty acids
Other: Babyfood with usual meat content and corn oil
Enrollment 132
Recruitment Details Mothers were first contacted in the hospital 1-3 days after delivery. Of 832 contacted families 132 agreed to participate in the study up to the baby's age of 8 weeks.
Pre-assignment Details All of the 132 participants were randomly assigned to one of the two study groups.
Arm/Group Title Participants in the Control Group Participants in the Intervention Group
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 66 66
Completed 55 [1] 52 [2]
Not Completed 11 14
Reason Not Completed
Lost to Follow-up             2             0
Withdrawal by Subject             1             2
Protocol Violation             3             3
infant refused study meal             3             4
Parent were afraid of blood colection             2             5
[1]
Excluded from analysis (n = 2) Reason: diet record for less than 75 % of days (n = 2)
[2]
Excluded n = 3) Reasons: diet record < 75 % of days (n = 2); blood analysis failed (n= 1)
Arm/Group Title Participants in the Control Group Participants in the Intervention Group Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 66 66 132
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
<=2 months at beginning Number Analyzed 66 participants 66 participants 132 participants
66 66 132
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 66 participants 132 participants
Female
35
  53.0%
32
  48.5%
67
  50.8%
Male
31
  47.0%
34
  51.5%
65
  49.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 66 participants 66 participants 132 participants
66 66 132
1.Primary Outcome
Title Sum of Omega-3 Fatty Acid Pattern in Plasma
Hide Description

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).

Time Frame at the end of the tenth month of life
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Participants in the Control Group Participants in the Intervention Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 55 52
Median (Inter-Quartile Range)
Unit of Measure: percent of total fatty acids
2.66
(2.33 to 2.87)
3.02
(2.85 to 3.66)
2.Primary Outcome
Title Parameters of Iron Status in Blood
Hide Description [Not Specified]
Time Frame at the end of the fourth, seventh, tenth month of life
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Dietary Intake; Anthropometric Measures: Body Weight, Body Lengths, Head Circumferences
Hide Description [Not Specified]
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
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Participants in the Control Group Participants in the Intervention Group
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Participants in the Control Group Participants in the Intervention Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Participants in the Control Group Participants in the Intervention Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/66 (0.00%)   0/66 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Participants in the Control Group Participants in the Intervention Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/66 (0.00%)   0/66 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dortmund Intervention Trial for Optimization of Infant Nutrition
Organization: Research Institute of Child Nutrition
Phone: 0049 231 7922100
Responsible Party: Research Institute of Child Nutrition, Dortmund
ClinicalTrials.gov Identifier: NCT00571948     History of Changes
Other Study ID Numbers: 2XIKers
First Submitted: December 11, 2007
First Posted: December 12, 2007
Results First Submitted: May 1, 2009
Results First Posted: January 9, 2015
Last Update Posted: May 21, 2015