Assessment of Complementary Feeding of Canadian Infants

NCT ID: NCT01790542

Last Updated: 2015-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2014-09-30

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

Conditions

Generation of Reactive Oxygen Species; Intestinal Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

A

Iron fortified cereal

Group Type: OTHER

Iron fortified cereal

Intervention Type: OTHER

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

B

Iron fortified cereal with fruit

Group Type: OTHER

Iron fortified cereal with fruit

Intervention Type: OTHER

C

Meat

Group Type: OTHER

Meat

Intervention Type: OTHER

Interventions

Iron fortified cereal

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

Intervention Type: OTHER

Iron fortified cereal with fruit

Intervention Type: OTHER

Meat

Intervention Type: OTHER

Other Intervention Names

Infant feeding

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

• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Manitoba

Winnipeg, Manitoba, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 28196533 (View on PubMed)

Related Links

http://www.facebook.com/pages/Assessment-of-Complementary-Feeding-of-Canadian-Infants-Study/529407130412012

Study Information

Other Identifiers

H2011:166

Identifier Type: -

Identifier Source: org_study_id