Clinical trial NCT05038995: The Effect of Early Cow's Milk Elimination Diet on the Growth Pattern
Official title: The Effect of Early Cow's Milk Elimination Diet on the Growth Pattern and Nutritional Status of Preschool Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cow Milk Allergy
Keywords: Cow milk allergy
Elimination diet
Anthropometry
Growth status
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2021-09-09
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric Allergy Department Outpatient Clinic and Healthy Child Outpatient Clinic

Brief summary: This study aimed to survey the growth of children who were on elimination diet due to cow milk allergy in Turkey. 0-5 year aged children diagnosed with cow's milk allergy (CMA) and healthy age-sex-matched children as the control group was planned for inclusion. Participants will be included in the study by consecutive sampling. The anthropometry measurements (height-for-age \[HFA\], weight-for-age \[WFA\], and weight-for-height \[WtHt\]) will be evaluated according to the Z-score using the WHO ANTHRO \[Z-score = Patient's value - Average value / Standard Deviation (SD)\]. The Z-score (SDS) in the average child by age was "0".

Detailed description: 0-5 year aged children diagnosed with cow's milk allergy (CMA) and healthy age-sex-matched children as the control group was planned for inclusion. The study will constitute of two groups; group 1; the children who received cow's milk elimination (CME) diet and group 2; the healthy controls. Group 1 will constitute of children aged 0-5 years who received a CME diet due to CMA (Ig E-mediated and/or non-Ig E-mediated and/or mixed type)\], confirmed by an oral food challenge test (OFC) and had reintroduced cow's milk for at least ≥ three months ago. Participants will be included in the study by consecutive sampling. The anthropometric measurements (height-for-age \[HFA\], weight-for-age \[WFA\], and weight-for-height \[WtHt\]) will be evaluated according to the Z-score using the WHO ANTHRO \[Z-score = Patient's value - Average value / Standard Deviation (SD)\]. The Z-score (SDS) in the average child by age was "0".

Eligibility criteria: Study Group Inclusion Criteria:

* had a diagnosis of CMA by OFC, except children with known anaphylaxis
* those on a CME diet or a specialized infant formula for at least three months
* had reintroduced cow's milk for at least three months ago.
* Children who excluded other foods in addition to cows' milk in the first four years of life for ≥ three months and who currently introduced these foods for at least ≥ three months were also enrolled in the CME group.

Healthy group inclusion criteria:

* did not have CMA and other allergic diseases
* who had never been on a diet throughout their lives.

Exclusion Criteria:

* Known acute (e.g., influenza) or chronic (e.g., diabetes, immune deficiencies ) diseases,
* history of systemic steroid use \> 0.5 mg/kg for more than one week in their life,
* recurrent infections within the last three months,
* food restriction other than food allergy (e.g., vegan, vegetarian),
* moderate to severe asthma, and other medical or surgical conditions which might affect nutrition and growth.

Primary outcomes:
measure: Body weight in kilograms-T0
timeFrame: One month prior to the diagnosis of CMA
measure: Body weight in kilograms-T1
timeFrame: On the 3-month of CME diet
measure: Body weight in kilograms-T2
timeFrame: Three months after the end of the CME diet
measure: Body weight in kilograms-T3
timeFrame: The last examination date of the patient after 3rd month control after CME diet
measure: Height in centimeters-T0
timeFrame: One month prior to the diagnosis of CMA
measure: Height in centimeters-T1
timeFrame: On the 3-month of CME diet
measure: Height in centimeters-T2
timeFrame: Three months after the end of the CME diet
measure: Height in centimeters-T3
timeFrame: The last examination date of the patient after 3rd month control after CME diet
measure: Head circumference in centimeters-T0
timeFrame: One month prior to the diagnosis of CMA
measure: Head circumference in centimeters-T1
timeFrame: On the 3-month of CME diet
measure: Head circumference in centimeters-T2
timeFrame: Three months after the end of the CME diet
measure: Head circumference in centimeters-T3
timeFrame: The last examination date of the patient after 3rd month control after CME diet
Secondary outcomes:
measure: Dietary intake
timeFrame: The last examination date of the patient after 3rd month control after CME diet
measure: Blood measurements-Hemoglobin
timeFrame: The last examination date of the patient after 3rd month control after CME diet
measure: Blood measurements-Sodium
timeFrame: The last examination date of the patient after 3rd month control after CME diet
measure: Blood measurements-Potassium
timeFrame: The last examination date of the patient after 3rd month control after CME diet
measure: Blood measurements-Albumin
timeFrame: The last examination date of the patient after 3rd month control after CME diet
measure: Blood measurements-Protein
timeFrame: The last examination date of the patient after 3rd month control after CME diet
measure: Blood measurements-Calcium
timeFrame: The last examination date of the patient after 3rd month control after CME diet
measure: Blood measurements-Vitamin B12
timeFrame: The last examination date of the patient after 3rd month control after CME diet
measure: Blood measurements-selenium
timeFrame: The last examination date of the patient after 3rd month control after CME diet
measure: Blood measurements-zinc
timeFrame: The last examination date of the patient after 3rd month control after CME diet
measure: Blood measurements-25-OH vitamin D
timeFrame: The last examination date of the patient after 3rd month control after CME diet
measure: Blood measurements-iron
timeFrame: The last examination date of the patient after 3rd month control after CME diet
measure: Blood measurements-Folate
timeFrame: The last examination date of the patient after 3rd month control after CME diet
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: University of Health Sciences, Gulhane Education and Research Hospital
Study officials:
affiliation: University of Health Sciences Turkey, Gulhane Education and Research Hospital
name: Nazli Ercan, MD
role: PRINCIPAL_INVESTIGATOR
References: