Iron StatusDINONCT00571948
Modification in Complementary Food Composition to Improve the Status of Iron and Fatty Acids in Infants.
A study testing more meat and a vegetable oil rich in omega-3 fatty acids and Babyfood with usual meat content and corn oil in people with Iron Status and Fatty Acid Status, run by Research Institute of Child Nutrition, Dortmund at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 1 week to 8 weeksHealthy volunteers can take part
- Conditions the study is for
- Iron Status, Fatty Acid Status
- What is being tested?
- more meat and a vegetable oil rich in omega-3 fatty acids and Babyfood with usual meat content and corn oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2005to Mar 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 week to 8 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- preterm infants
Trial locations and contacts
1 site in 1 country.
Germany1 site
Research Institute of Child Nutrition
Dortmund, Nord-Rhein-Westfalen, 44225
About this study
Official title: Dortmund Intervention Trial for Optimization of Infant Nutrition
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.
Read the 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).
- Conditions
- Iron Status, Fatty Acid Status
- Being tested
- more meat and a vegetable oil rich in omega-3 fatty acids, Babyfood with usual meat content and corn oil
- Keywords
- infant, complementary food, iron, meat, LC-PUFA, omega-3,, rapeseed oil, diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: more meat and a vegetable oil rich in omega-3 fatty acids; Other: 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. Receives: Other: more meat and a vegetable oil rich in omega-3 fatty acids; Other: Babyfood with usual meat content and corn oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: at the end of the tenth month of life
Parameters of Iron Status in Blood
Measured: at the end of the fourth, seventh, tenth month of life
Secondary outcomes (1)
Dietary Intake; Anthropometric Measures: Body Weight, Body Lengths, Head Circumferences
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2007 (estimated)
- Study startSep 2005
- Primary completionJul 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Iron StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Institute of Child Nutrition, Dortmund
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathilde Kersting, PD Dr., Principal investigator, Research Institute of Child Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00571948
- Sponsor's protocol ID
- 2XIKers
- Acronym
- DINO
- Status last verified
- May 2015
- First submitted
- 11 Dec 2007
- Last updated
- 21 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 19193660Schwartz 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.
PubMed 19935821Schwartz 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.
PubMed 19851802Dube 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.
PubMed 19618230Dube 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.
PubMed 20627488
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dortmund Intervention Trial for Optimization of Infant Nutrition
- ClinicalTrials.gov ID
- NCT00571948
- Acronym / sponsor ID
- DINO / 2XIKers
- Conditions
- Iron Status, Fatty Acid Status
- Keywords
- infant, complementary food, iron, meat, LC-PUFA, omega-3,, rapeseed oil, diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Research Institute of Child Nutrition, DortmundUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Jul 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 12 Dec 2007 (estimated)
- Results
- Posted 9 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Babyfood with usual meat content and corn oil | Active comparator | Other: more meat and a vegetable oil rich in omega-3 fatty acids, Other: Babyfood with usual meat content and corn oilInfants 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. |
| more meat and a vegetable oil rich in omega-3 fatty acids | Experimental | Other: more meat and a vegetable oil rich in omega-3 fatty acids, Other: Babyfood with usual meat content and corn oilInfants 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. |
Who may qualify
- Ages
- 1 week to 8 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- preterm infants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| more meat and a vegetable oil rich in omega-3 fatty acidsThe 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). | Other | Babyfood with usual meat content and corn oil, more meat and a vegetable oil rich in omega-3 fatty acids |
| Babyfood with usual meat content and corn oilThe 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 | Other | Babyfood with usual meat content and corn oil, more meat and a vegetable oil rich in omega-3 fatty acids |
Primary outcome
Sum of Omega-3 Fatty Acid Pattern in Plasma
Time frame: 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).
Parameters of Iron Status in Blood
Time frame: at the end of the fourth, seventh, tenth month of life
1 secondary outcome
Dietary Intake; Anthropometric Measures: Body Weight, Body Lengths, Head Circumferences
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19193660Schwartz 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.
- Results publication: PubMed 19935821Schwartz 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.
- Results publication: PubMed 19851802Schwartz 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.
- Results publication: PubMed 19618230Dube 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.
- Derived from this study: PubMed 20627488Dube 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathilde Kersting, PD Dr. principal investigator
Research Institute of Child Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing more meat and a vegetable oil rich in omega-3 fatty acids and Babyfood with usual meat content and corn oil in people with Iron Status and Fatty Acid Status, run by Research Institute of Child Nutrition, Dortmund at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sum of Omega-3 Fatty Acid Pattern in Plasma (time frame: at the end of the tenth month of life). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00571948, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2015.