Improving Nutrient Intake and Growth in Children With Multiple Food Allergies

NCT01571830 | Completed

• 1 other identifier: CHW 11/181, GC 1404
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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. o
• 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.

Conditions

Food Allergy

Keywords

food allergy; nutrient intake; growth

Outcome Measures

Primary Outcomes (1)

• Growth

  Weight for age, length/height for age, and weight for length/height z-scores will be assessed. Growth will be compared to reference standards. Growth velocity will be calculated in grams/day.

  6 months

Secondary Outcomes (1)

• Nutrient intake

  6 months

Eligibility Criteria

• Age: 6 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

New patients to the Allergy \& Immunology outpatient clinic at Children's Hospital of Wisconsin (CHW).

You may qualify if:

• Age 6 months to 6 years
• or more food allergies
• At least one of the food allergies must be milk, egg, wheat, or soy
• Confirmed with skin prick testing or SIgE
• Diagnosed at CHW Asthma, Allergy, \& Immunology Clinic
• Second opinions are included as long as patient has never been seen by a dietitian for food allergies

You may not qualify if:

• Previously seen by a dietitian for food allergies
• Developmental delay
• Genetic syndrome
• Other chronic medical conditions besides asthma, eczema, or eosinophilic esophagitis
• Hyper-IgE syndrome
• Immune deficiency disease
• History of digestive surgery
• Non-English speaking
• Currently receiving nutrition support (enteral or parenteral nutrition)
• Received oral steroids for more than 7 days in the previous three months

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53201, United States

Location

Related Publications (1)

• Johnson RK, Driscoll P, Goran MI. Comparison of multiple-pass 24-hour recall estimates of energy intake with total energy expenditure determined by the doubly labeled water method in young children. J Am Diet Assoc. 1996 Nov;96(11):1140-4. doi: 10.1016/S0002-8223(96)00293-3.

  PMID: 8906138 BACKGROUND

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Praveen Goday, MD

  Medical College of Wisconsin & Children's Hospital of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2012
• First Posted: April 5, 2012
• Study Start: December 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: August 6, 2015

Record last verified: 2015-08

Locations

US (1)