Food AllergyNCT01571830
Improving Nutrient Intake and Growth in Children With Multiple Food Allergies
An observational study of Food Allergy, run by Medical College of Wisconsin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 6 years
- Conditions the study is for
- Food Allergy
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: New patients to the Allergy \& Immunology outpatient clinic at Children's Hospital of Wisconsin (CHW).
Who may be able to join
- Age 6 months to 6 years
- 2 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53201
About this study
- 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.
- 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.
Read the detailed description
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 procedures. The Mealtime Behavior Questionnaire (MBQ) and Feeding Strategies Questionnaire (FSQ) will be filled out by the parent or guardian. Demographic data and medical history will be obtained. Height/length, weight, and head circumference from the first allergist visit will be obtained from the medical record and recorded for use in the study. A multiple-pass 24-hour recall will be completed. In addition, they will receive standardized nutrition intervention to include nutrition assessment, food allergy education, and general nutrition education.
The participant will attend a second visit with the dietitian. Height, weight, and head circumference will be measured and recorded using standard procedures. A multiple-pass 24-hour recall will be completed. The participant's parent or guardian will complete the MBQ and FSQ. Follow-up nutrition intervention will include nutrition reassessment, food allergy education as needed, and general nutrition education as needed.
All aspects of this study, with the exception of MBQ, and FSQ, are the current standard of care in the Asthma, Allergy, and Immunology clinic for patients with multiple food allergies.
- Conditions
- Food Allergy
- Keywords
- food allergy, nutrient intake, growth
- Medical subject headings
- Food Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
Nutrient intake
Changes in nutrient intake will be assessed using a multiple-pass 24 hour recalls administered at 4 times throughout the 6 month study period. Nutrient intake will be compared with the Dietary Reference Intakes (DRI) and changes in nutrient intake over time will be assessed. The primary goal is to assess changes in nutrient intake before and after nutrition intervention.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2012 (estimated)
- Study startDec 2011
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Praveen Goday, MD, Principal investigator, Medical College of Wisconsin & Children's Hospital of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01571830
- Sponsor's protocol ID
- CHW 11/181, GC 1404
- Status last verified
- Aug 2015
- First submitted
- 3 Apr 2012
- Last updated
- 6 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 8906138
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Nutrient Intake and Growth in Children With Multiple Food Allergies
- ClinicalTrials.gov ID
- NCT01571830
- Acronym / sponsor ID
- CHW 11/181, GC 1404
- Conditions
- Food Allergy
- Keywords
- food allergy, nutrient intake, growth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 5 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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.
Detailed description
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 procedures. The Mealtime Behavior Questionnaire (MBQ) and Feeding Strategies Questionnaire (FSQ) will be filled out by the parent or guardian. Demographic data and medical history will be obtained. Height/length, weight, and head circumference from the first allergist visit will be obtained from the medical record and recorded for use in the study. A multiple-pass 24-hour recall will be completed. In addition, they will receive standardized nutrition intervention to include nutrition assessment, food allergy education, and general nutrition education.
The participant will attend a second visit with the dietitian. Height, weight, and head circumference will be measured and recorded using standard procedures. A multiple-pass 24-hour recall will be completed. The participant's parent or guardian will complete the MBQ and FSQ. Follow-up nutrition intervention will include nutrition reassessment, food allergy education as needed, and general nutrition education as needed.
All aspects of this study, with the exception of MBQ, and FSQ, are the current standard of care in the Asthma, Allergy, and Immunology clinic for patients with multiple food allergies.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- New patients to the Allergy \& Immunology outpatient clinic at Children's Hospital of Wisconsin (CHW).
Key inclusion criteria (6 listed)
- Age 6 months to 6 years
- 2 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Growth
Time frame: 6 months
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.
1 secondary outcome
Nutrient intake
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2015.
- Background: PubMed 8906138Johnson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Praveen Goday, MD principal investigator
Medical College of Wisconsin & Children's Hospital of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Allergy, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01571830, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2015.