Clinical trial NCT01790542: Assessment of Complementary Feeding of Canadian Infants
Official title: Assessment of Complementary Feeding of Canadian Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Generation of Reactive Oxygen Species
Intestinal Inflammation
Keywords: Iron
Intestinal inflammation
ROS
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2013-02-13
Enrollment: 87
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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. 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:

1. Consumption of infant cereals with iron will increase ROS generation in the gut
2. Consumption of infant cereals with iron and fruit will decrease ROS in the gut
3. Consumption of meat will not generate ROS
4. Consumption of iron fortified cereals or meat will maintain iron status during infancy


Eligibility criteria: Inclusion Criteria:

* Full term infant
* Birth weight more than 2500g
* Absence of any medical conditions

Exclusion Criteria:

* Consumption of more than 200ml formula

Primary outcomes:
measure: Change in production of ROS
timeFrame: Before introduction of study food and 2-3 weeks after introduction of study food
Secondary outcomes:
measure: Change in Microbiome
timeFrame: Before introduction of study food and 2-3 weeks after introduction of study food
measure: Change in Fecal Calprotectin
timeFrame: Before introduction of study food and 2-3 weeks after introduction of study food
measure: Fecal non heme iron production
timeFrame: Before introduction of study food and 2-3 weeks after introduction of study food
measure: Dietary iron intake from first complementary food
timeFrame: 3 days dietary record
measure: Micro and Macro nutrient intake of breastfed infants from first complementary food
timeFrame: 3 days dietary record
Other outcomes:
measure: Change in 8OH-deoxyguanosine
timeFrame: Before introduction of study food and 2-3 weeks after introduction of study food
measure: Change in F2 Isoprostane
timeFrame: Before introduction of study food and 2-3 weeks after introduction of study food
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
References:
citation: 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.