Nutrition in Children With Food Allergy
2 other identifiers
observational
70
1 country
1
Brief Summary
The investigators aim to asses the effect of dieto-therapy and of nutritional counseling on the nutritional status, body growth and tolerance acquisition in children with cow's milk allergy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 5, 2012
CompletedFirst Posted
Study publicly available on registry
April 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedApril 25, 2012
April 1, 2012
1 year
April 5, 2012
April 24, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in anthropometric indices after dieto-therapy intervention and nutritional counseling in children with cow's milk allergy
Anthropometric indices (z-score for weight, length and head circumference) will be collected at the enrolment (T0) and after 2 (T1), 4 (T2) and 6 months (T3) by experienced nurse unaware to of the study aims. Dietary intake will be assessed by a 3-day diary at T0 and at T3. The nutrient intake will be analyzed using a specific software. The following laboratory measurements will be also analyzed at T0 and at T3: haemoglobin, albumin, total cholesterol, triglycerides, calcium, phosphorus, zinc, fatty acids.
1 year
Secondary Outcomes (2)
Change in nutritional status after dieto-therapy intervention and nutritional counseling in children with cow's milk allergy
1 year
Change in time of tolerance acquisition after dieto-therapy intervention in children with cow's milk allergy.
1 year
Study Arms (1)
different dietotherapy strategies
Eligibility Criteria
children with a sure diagnosis of food allergy
You may qualify if:
- Patients 6-36 months of age with a suspected FA
You may not qualify if:
- Unconfirmed diagnosis of FA
- Prematurity
- Systemic disease
- Renal failure
- Neurological impairment
- Active tuberculosis
- Autoimmune diseases
- Immunodeficiency
- Chronic inflammatory bowel diseases
- Celiac disease
- Cystic fibrosis
- Metabolic or endocrine diseases
- Malignancy
- Malformation of the gastrointestinal or the urinary tract
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
university of naples federico II
Naples, Naples, 80131, Italy
Biospecimen
blood sampling to measure laboratory parameters useful to asses nutritional status
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
April 5, 2012
First Posted
April 24, 2012
Study Start
March 1, 2012
Primary Completion
March 1, 2013
Study Completion
March 1, 2014
Last Updated
April 25, 2012
Record last verified: 2012-04