The Effect of Early Cow's Milk Elimination Diet on the Growth Pattern

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Early Cow's Milk Elimination Diet on the Growth Pattern and Nutritional Status of Preschool Children

Conditions
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Cow Milk Allergy

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cow milk elimination group<br>The CME children will be eligible for the study if they (1) had a diagnosis of CMA by OFC, except children with known anaphylaxis (2) those on a CME diet or a specialized infant formula for at least three months (3) 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 will be also enrolled in the CME group. | |
| Healthy group<br>Healthy children will ve eligible for the study if they (1) did not have CMA and other allergic diseases (2) who had never been on a diet throughout their lives. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight in kilograms-T0 | Body weight (kg) | One month prior to the diagnosis of CMA | 
| Body weight in kilograms-T1 | Body weight (kg) | On the 3-month of CME diet | 
| Body weight in kilograms-T2 | Body weight (kg) | Three months after the end of the CME diet | 
| Body weight in kilograms-T3 | Body weight (kg) | The last examination date of the patient after 3rd month control after CME diet | 
| Height in centimeters-T0 | Height (cm) | One month prior to the diagnosis of CMA | 
| Height in centimeters-T1 | Height (cm) | On the 3-month of CME diet | 
| Height in centimeters-T2 | Height (cm) | Three months after the end of the CME diet | 
| Height in centimeters-T3 | Height (cm) | The last examination date of the patient after 3rd month control after CME diet | 
| Head circumference in centimeters-T0 | Head circumference (cm) | One month prior to the diagnosis of CMA | 
| Head circumference in centimeters-T1 | Head circumference (cm) | On the 3-month of CME diet | 
| Head circumference in centimeters-T2 | Head circumference (cm) | Three months after the end of the CME diet | 
| Head circumference in centimeters-T3 | Head circumference (cm) | The last examination date of the patient after 3rd month control after CME diet | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary intake | Three day dietary record | The last examination date of the patient after 3rd month control after CME diet | 
| Blood measurements-Hemoglobin | Hemoglobin g/dl | The last examination date of the patient after 3rd month control after CME diet | 
| Blood measurements-Sodium | sodium mg/ml | The last examination date of the patient after 3rd month control after CME diet | 
| Blood measurements-Potassium | Potassium | The last examination date of the patient after 3rd month control after CME diet | 
| Blood measurements-Albumin | Albumin | The last examination date of the patient after 3rd month control after CME diet | 
| Blood measurements-Protein | Protein | The last examination date of the patient after 3rd month control after CME diet | 
| Blood measurements-Calcium | Calcium | The last examination date of the patient after 3rd month control after CME diet | 
| Blood measurements-Vitamin B12 | Vitamin B12 | The last examination date of the patient after 3rd month control after CME diet | 
| Blood measurements-selenium | Selenium | The last examination date of the patient after 3rd month control after CME diet | 
| Blood measurements-zinc | Zinc | The last examination date of the patient after 3rd month control after CME diet | 
| Blood measurements-25-OH vitamin D | 25-OH vitamin D | The last examination date of the patient after 3rd month control after CME diet | 
| Blood measurements-iron | Iron | The last examination date of the patient after 3rd month control after CME diet | 
| Blood measurements-Folate | Folate | The last examination date of the patient after 3rd month control after CME diet | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cow milk allergy, Elimination diet, Anthropometry, Growth status