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Completed

NCT Number: NCT01790542

Assessment of Complementary Feeding of Canadian Infants

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

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Key information

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Manitoba

Winnipeg, Manitoba, R3T6C5, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Consumption of more than 200ml formula

Treatment and study plan

Iron fortified cereal

Other

Infants will be assigned to one of the three interventions: A (iron fortified cereal), B (iron fortified cereal with fruit), C (Meat)

Other names: Infant feeding

Iron fortified cereal with fruit

Other

Meat

Other

Primary outcomes

  1. 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

Secondary outcomes

  1. Change in Microbiome

    Time frame: Before introduction of study food and 2-3 weeks after introduction of study food

    Microflora of term infants before and after the introduction of solids

  2. Change in Fecal Calprotectin

    Time frame: Before introduction of study food and 2-3 weeks after introduction of study food

    Inflammatory marker

  3. Fecal non heme iron production

    Time frame: Before introduction of study food and 2-3 weeks after introduction of study food

    Non heme iron founded in infant cereal is less absorbed, remains in the gut, and excreted in the feces.

  4. Dietary iron intake from first complementary food

    Time frame: 3 days dietary record

  5. Micro and Macro nutrient intake of breastfed infants from first complementary food

    Time frame: 3 days dietary record

Other outcomes

  1. Change in 8OH-deoxyguanosine

    Time frame: Before introduction of study food and 2-3 weeks after introduction of study food

    Oxidative stress marker in the urine

  2. Change in F2 Isoprostane

    Time frame: Before introduction of study food and 2-3 weeks after introduction of study food

    Oxidative stress marker in the urine

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Acronym: Infant Feeding

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 13, 2013
Registry last updated
May 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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