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Nutrition in Children With Food Allergy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Federico II University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Roberto Berni Canani, Federico II University
ClinicalTrials.gov Identifier:
NCT01583907
First received: April 5, 2012
Last updated: April 24, 2012
Last verified: April 2012
  Purpose

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.


Condition Phase
Food Allergy
Phase 0

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Federico II University:

Primary Outcome Measures:
  • Change in anthropometric indices after dieto-therapy intervention and nutritional counseling in children with cow's milk allergy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change in nutritional status after dieto-therapy intervention and nutritional counseling in children with cow's milk allergy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.

  • Change in time of tolerance acquisition after dieto-therapy intervention in children with cow's milk allergy. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    After 12 months of dietotherapy with different formulas tolerance acquisition will be investigated performing a double blind placebo controlled oral food challenge.


Biospecimen Retention:   Samples Without DNA

blood sampling to measure laboratory parameters useful to asses nutritional status


Estimated Enrollment: 70
Study Start Date: March 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
different dietotherapy strategies

Detailed Description:

Prospective controlled study including patients with cow's milk allergy(6-36 months of age.During the first examination, the diagnosis will be assessed by pediatricians with great experience in food allergy, checking that the patient had undergone a standardized procedure. All cases with an unclear diagnosis of FA (i.e., lack of careful medical history, laboratory studies, and oral food challenge) or on incorrect exclusion diet (i.e., assumption of at least traces of the food allergen) will be excluded. Children with a positive history for prematurity, systemic diseases, renal failure, neurological impairment, active tuberculosis, autoimmune diseases, immunodeficiency, chronic inflammatory bowel diseases, celiac disease, cystic fibrosis, metabolic or endocrine diseases, malignancy and malformation of the gastrointestinal or the urinary tract will be also excluded. The history of each patient will be evaluated and the results of FA screening tests (i.e., skin prick tests and atopy patch tests) and of oral food challenge, together with all demographic and clinical information will be registered into a specific clinical chart. At enrolment (T0), after 2 (T1),4 (T2), 6(T3)and 12 months (T4) weight, length or height and head circumference were measured by experienced nurse unaware of the study aims using standardized procedures. The anthropometric indices (z-score for weight, z-score for length/height, z-score for head circumference) will be also evaluated for all study subjects. Anthropometric measurements will be compared with the Euro-Growth References Charts. At the end of the first visit the parents of all children taking part in the study will be asked to fill a 3-day diet record report in a form of a printed chart. Written informed consent will be obtained from parents of each child enrolled in the study.

Nutritional counseling Enrolled subjects will be evaluated by registered dieticians with a wide experience in pediatric FA, blinded to the study aims, assessing the results of the 3-day diary dietary intake at enrollment (T0), at 6 months (T3) and 12 months (T4). All diaries will be collected and analyzed using a specific software based on the Italian food composition tables. The dieticians will evaluate the results of the 3-day diary and will give information to the parents about issues potentially arising during dietary elimination and on how to replace the allergen in the diet with alternative food items equivalent on the nutritional standpoint according to specific dietary recommended intake (DRI) for Italian children for age and sex .The nutritional counseling will be also focused on feeding behaviors, selection pleasant food and children preferences. No nutritional support products will be prescribed. This is the standard procedure in the management of FA in the centers involved in the study.

Laboratory measurements At the enrollment and after 6 months (T3) after nutritional intervention a venous blood sample will be collected from children with FA on elimination diet. The following laboratory measurements will be analyzed through standardized procedures: hemoglobin, albumin, total cholesterol, triglycerides, calcium, phosphorus, and zinc.

To investigate the patients rate of tolerance acquisition after 12 months of exclusion diet an oral food challenge (OFC) will be performed.

  Eligibility

Ages Eligible for Study:   6 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

children with a sure diagnosis of food allergy

Criteria

Inclusion Criteria:

  • Patients 6-36 months of age with a suspected FA

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01583907

Contacts
Contact: roberto berni canani, MD,PhD berni@unina.it

Locations
Italy
university of naples federico II Recruiting
Naples, Italy, 80131
Contact: roberto berni canani, MD,Phd       berni@unina.it   
Sponsors and Collaborators
Federico II University
  More Information

No publications provided

Responsible Party: Roberto Berni Canani, MD, PhD, Federico II University
ClinicalTrials.gov Identifier: NCT01583907     History of Changes
Other Study ID Numbers: RBC-100789, 100789
Study First Received: April 5, 2012
Last Updated: April 24, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Federico II University:
cow's milk allergy

Additional relevant MeSH terms:
Food Hypersensitivity
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on November 23, 2014