Trial Outcomes & Findings for Modification in Complementary Food Composition to Improve the Status of Iron and Fatty Acids in Infants. (NCT NCT00571948)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

132 participants

Primary outcome timeframe

at the end of the tenth month of life

Results posted on

2015-05-21

Participant Flow

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.

All of the 132 participants were randomly assigned to one of the two study groups.

Participant milestones

Participant milestones
Measure	Participants in the Control Group 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.	Participants in the Intervention Group 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 Study STARTED	66	66
Overall Study COMPLETED	55	52
Overall Study NOT COMPLETED	11	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Participants in the Control Group 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.	Participants in the Intervention Group 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 Study Lost to Follow-up	2	0
Overall Study Withdrawal by Subject	1	2
Overall Study Protocol Violation	3	3
Overall Study infant refused study meal	3	4
Overall Study Parent were afraid of blood colection	2	5

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants in the Control Group n=66 Participants 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.	Participants in the Intervention Group n=66 Participants 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 n=132 Participants Total of all reporting groups
Age, Customized <=2 months at beginning	66 Participants n=5 Participants	66 Participants n=7 Participants	132 Participants n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	32 Participants n=7 Participants	67 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	34 Participants n=7 Participants	65 Participants n=5 Participants
Region of Enrollment Germany	66 participants n=5 Participants	66 participants n=7 Participants	132 participants n=5 Participants

PRIMARY outcome

Timeframe: at the end of the tenth month of life

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).

Outcome measures

Outcome measures
Measure	Participants in the Control Group n=55 Participants 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.	Participants in the Intervention Group n=52 Participants 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.
Sum of Omega-3 Fatty Acid Pattern in Plasma	2.66 percent of total fatty acids Interval 2.33 to 2.87	3.02 percent of total fatty acids Interval 2.85 to 3.66

PRIMARY outcome

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

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Outcome measures

Outcome data not reported

Adverse Events

Participants in the Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Participants in the Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dortmund Intervention Trial for Optimization of Infant Nutrition

Research Institute of Child Nutrition

Phone: 0049 231 7922100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place