Clinical Trial: Improving Nutrient Intake and Growth in Children With Multiple Food Allergies

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Improving Nutrient Intake and Growth in Children With Multiple Food Allergies

Brief Summary:

• Hypothesis 1: Food allergies are associated with poor growth which can be corrected with nutrition intervention.

  • More than 10% of children with multiple food allergies will have a weight-for-age z-score less than - 2 at diagnosis. The z-score is a measure of the distance from the mean value, or 50th percentile on the growth chart. A z-score of less than - 2 indicates that the child is underweight.
  • Growth parameters of children with multiple food allergies will improve after intervention by a team that includes a dietitian and an allergist.

• Hypothesis 2: Food allergies are associated with low micronutrient intake which can be corrected with nutrition intervention.

  o More than 30% of children with multiple food allergies will consume less than 67% of the Dietary Reference Intake for at least one macronutrient or micronutrient at diagnosis.

• Macronutrient and micronutrient intake will increase after intervention by a team that includes a dietitian and an allergist.

• Hypothesis 3: Food allergies are related to behavioral feeding problems which can be corrected with nutrition intervention.

• At least 25% of children with multiple food allergies will have behavioral feeding problems at diagnosis.
• Prevalence of behavioral feeding problems will decrease after nutrition intervention.

Detailed Summary:

This is a prospective observational study with repeated measure design. All participants aged 6 months to 6 years diagnosed with two or more food allergies will be invited to participate in the research study. At least one of the two food allergies must be milk, egg, wheat, or soy, which are nutritionally important food allergies. Inclusion criteria include diagnosis of two or more food allergies confirmed with skin prick testing or serum specific IgE (SIgE)testing. Participants aged 12 months or older will be invited to participate in the Mealtime Behavior Questionnaire (MBQ) and Feeding Strategies Questionnaire (FSQ). Participants with developmental delay, genetic syndromes or other chronic medical conditions will be excluded from the study. Participants with two or more food allergies that do not have at least one nutritionally important food allergy (milk, egg, wheat, soy) will not be invited to participate in the study. We will also exclude participants with a history of digestive surgery, non English-speaking patients, and patients currently receiving nutrition support (enteral or parenteral nutrition). Patients will be excluded if they received greater than one week of oral steroids in the previous three months. Exclusively breastfed infants will be excluded from the study as their nutrient intake cannot accurately assessed (must consume at least some foods or formulas). We will include patients if they have asthma, eczema, or both. There will be no control group recruited for the study as comparisons will be made within the study population.

Subjects will be recruited from the Asthma, Allergy, & Immunology Clinic at the main campus of Children's Hospital of Wisconsin. At the first visit with the dietitian, subjects will be enrolled and consent will be obtained. Height, weight, and head circumference (until 2 YO) will be measured and recorded using standard pro
Sponsor: Medical College of Wisconsin

Current Primary Outcome: Growth [ Time Frame: 6 months ]

Original Primary Outcome: Growth [ Time Frame: 6 months ]

Current Secondary Outcome: Nutrient intake [ Time Frame: 6 months ]

Original Secondary Outcome: Nutrient intake [ Time Frame: 6 months ]

Information By: Medical College of Wisconsin

Dates:
Date Received: April 3, 2012
Date Started: December 2011
Date Completion:
Last Updated: August 5, 2015
Last Verified: August 2015