Generation of Reactive Oxygen SpeciesInfant FeedingNCT01790542
Assessment of Complementary Feeding of Canadian Infants
A study testing Iron fortified cereal, Iron fortified cereal with fruit and Meat in people with Generation of Reactive Oxygen Species and Intestinal Inflammation, run by University of Manitoba at 1 site in Canada.
Trial summary
With the recent recommendation from Health Canada to extend exclusive breast-feeding to 6 months of age there has arisen concern about what is the best solid food to introduce at that time. Traditionally solids were introduced in Canada at 4-6 months and usually iron-fortified rice cereal was the first food of choice. Read more about this study
- Who is it for?
- Ages Up to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Generation of Reactive Oxygen Species, Intestinal Inflammation
- What is being tested?
- Iron fortified cereal, Iron fortified cereal with fruit and Meat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2012to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Full term infant
- Birth weight more than 2500g
- Absence of any medical conditions
Who cannot join
- Consumption of more than 200ml formula
Trial locations and contacts
1 site in 1 country.
About this study
With the recent recommendation from Health Canada to extend exclusive breast-feeding to 6 months of age there has arisen concern about what is the best solid food to introduce at that time. Traditionally solids were introduced in Canada at 4-6 months and usually iron-fortified rice cereal was the first food of choice. New recommendations from Health Canada include meat as a potential first food as well as other iron fortified foods. This has lead to uncertainty of both public health officials and parents about the optimal introduction and choice of solids after exclusive breastfeeding.
In addition to meeting iron needs with the first solid food choice, the investigators are concerned about the possible generation of reactive oxygen species (ROS) in the gut of the infant fed traditional iron fortified cereals. Infant cereals are fortified at 25-30 mg iron per 100 g dry-weight. Absorption of the non-heme electrolytic iron ranges from 5-10% so that most of the residual iron enters the colon. Normally excess iron is sequestered by a variety of mechanisms in the body, but there is no such system for the sequestering of iron in the gut lumen. The investigators have shown that providing iron supplements to adults where the majority of the iron is unabsorbed passes through the digestive tract can lead to the generation of ROS in the colon. These effects are seen in adults receiving 1 mg/kg/day supplemental iron. By 5-6 months of age infants consuming iron fortified cereals will receive the same dose and are likely producing ROS in their digestive tract. This may cause inflammation and make infants more susceptible to disease. The investigators think that meats and infant cereals with phenolic antioxidants available from fruits will likely reduce the generation of ROS in vivo. Therefore the investigators wish to determine if traditional and newly recommended first foods are safe from a free radical and inflammatory perspective.
Read more
HYPOTHESES:
- Consumption of infant cereals with iron will increase ROS generation in the gut
- Consumption of infant cereals with iron and fruit will decrease ROS in the gut
- Consumption of meat will not generate ROS
- Consumption of iron fortified cereals or meat will maintain iron status during infancy
- Being tested
- Iron fortified cereal, Iron fortified cereal with fruit, Meat
- Keywords
- Iron, Intestinal inflammation, ROS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron fortified cerealOther
Also called Infant feeding
Infants will be assigned to one of the three interventions: A (iron fortified cereal), B (iron fortified cereal with fruit), C (Meat)
Iron fortified cereal with fruitOther
MeatOther
| Study group | Role | What they receive |
|---|---|---|
| A | Other | Iron fortified cereal Receives: Other: Iron fortified cereal |
| B | Other | Iron fortified cereal with fruit Receives: Other: Iron fortified cereal with fruit |
| C | Other | Meat Receives: Other: Meat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in production of ROS
Production of reactive oxygen species
Measured: Before introduction of study food and 2-3 weeks after introduction of study food
Secondary outcomes (5)
Change in Microbiome
Microflora of term infants before and after the introduction of solids
Measured: Before introduction of study food and 2-3 weeks after introduction of study food
Change in Fecal Calprotectin
Inflammatory marker
Measured: Before introduction of study food and 2-3 weeks after introduction of study food
Fecal non heme iron production
Non heme iron founded in infant cereal is less absorbed, remains in the gut, and excreted in the feces.
Measured: Before introduction of study food and 2-3 weeks after introduction of study food
Dietary iron intake from first complementary food
Measured: 3 days dietary record
Micro and Macro nutrient intake of breastfed infants from first complementary food
Measured: 3 days dietary record
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startDec 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Generation of Reactive Oxygen SpeciesStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01790542
- Sponsor's protocol ID
- H2011:166
- Acronym
- Infant Feeding
- Status last verified
- Jul 2014
- First submitted
- 6 Feb 2013
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Qasem W, Azad MB, Hossain Z, Azad E, Jorgensen S, Castillo San Juan S, Cai C, Khafipour E, Beta T, Roberts LJ 2nd, Friel J. Assessment of complementary feeding of Canadian infants: effects on microbiome & oxidative stress, a randomized controlled trial. BMC Pediatr. 2017 Feb 14;17(1):54. doi: 10.1186/s12887-017-0805-0.
PubMed 28196533
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Complementary Feeding of Canadian Infants
- ClinicalTrials.gov ID
- NCT01790542
- Acronym / sponsor ID
- Infant Feeding / H2011:166
- Keywords
- Iron, Intestinal inflammation, ROS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 13 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With the recent recommendation from Health Canada to extend exclusive breast-feeding to 6 months of age there has arisen concern about what is the best solid food to introduce at that time. Traditionally solids were introduced in Canada at 4-6 months and usually iron-fortified rice cereal was the first food of choice. New recommendations from Health Canada include meat as a potential first food as well as other iron fortified foods. This has lead to uncertainty of both public health officials and parents about the optimal introduction and choice of solids after exclusive breastfeeding.
In addition to meeting iron needs with the first solid food choice, the investigators are concerned about the possible generation of reactive oxygen species (ROS) in the gut of the infant fed traditional iron fortified cereals. Infant cereals are fortified at 25-30 mg iron per 100 g dry-weight. Absorption of the non-heme electrolytic iron ranges from 5-10% so that most of the residual iron enters the colon. Normally excess iron is sequestered by a variety of mechanisms in the body, but there is no such system for the sequestering of iron in the gut lumen. The investigators have shown that providing iron supplements to adults where the majority of the iron is unabsorbed passes through the digestive tract can lead to the generation of ROS in the colon. These effects are seen in adults receiving 1 mg/kg/day supplemental iron. By 5-6 months of age infants consuming iron fortified cereals will receive the same dose and are likely producing ROS in their digestive tract. This may cause inflammation and make infants more susceptible to disease. The investigators think that meats and infant cereals with phenolic antioxidants available from fruits will likely reduce the generation of ROS in vivo. Therefore the investigators wish to determine if traditional and newly recommended first foods are safe from a free radical and inflammatory perspective.
HYPOTHESES:
- Consumption of infant cereals with iron will increase ROS generation in the gut
- Consumption of infant cereals with iron and fruit will decrease ROS in the gut
- Consumption of meat will not generate ROS
- Consumption of iron fortified cereals or meat will maintain iron status during infancy
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Other | Other: Iron fortified cerealIron fortified cereal |
| B | Other | Other: Iron fortified cereal with fruitIron fortified cereal with fruit |
| C | Other | Other: MeatMeat |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Full term infant
- Birth weight more than 2500g
- Absence of any medical conditions
Key exclusion criteria (1 listed)
- Consumption of more than 200ml formula
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 |
|---|---|---|
| Iron fortified cerealAlso: Infant feedingInfants will be assigned to one of the three interventions: A (iron fortified cereal), B (iron fortified cereal with fruit), C (Meat) | Other | A |
| Iron fortified cereal with fruit | Other | B |
| Meat | Other | C |
Primary outcome
Change in production of ROS
Time frame: Before introduction of study food and 2-3 weeks after introduction of study food
Production of reactive oxygen species
5 secondary outcomes
Change in Microbiome
Time frame: Before introduction of study food and 2-3 weeks after introduction of study food
Change in Fecal Calprotectin
Time frame: Before introduction of study food and 2-3 weeks after introduction of study food
Fecal non heme iron production
Time frame: Before introduction of study food and 2-3 weeks after introduction of study food
Dietary iron intake from first complementary food
Time frame: 3 days dietary record
Micro and Macro nutrient intake of breastfed infants from first complementary food
Time frame: 3 days dietary record
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
- Derived from this study: PubMed 28196533Qasem W, Azad MB, Hossain Z, Azad E, Jorgensen S, Castillo San Juan S, Cai C, Khafipour E, Beta T, Roberts LJ 2nd, Friel J. Assessment of complementary feeding of Canadian infants: effects on microbiome & oxidative stress, a randomized controlled trial. BMC Pediatr. 2017 Feb 14;17(1):54. doi: 10.1186/s12887-017-0805-0.
- Study InformationLink provided by the sponsor.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iron fortified cereal, Iron fortified cereal with fruit and Meat in people with Generation of Reactive Oxygen Species and Intestinal Inflammation, run by University of Manitoba at 1 site in Canada.
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 28 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in production of ROS (time frame: Before introduction of study food and 2-3 weeks after introduction of study food). 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 NCT01790542, which also lists 1 linked publication.
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 28 May 2015.