The Effect of Early Cow's Milk Elimination Diet on the Growth Pattern
- Conditions
- Cow Milk Allergy
- Registration Number
- NCT05038995
- Lead Sponsor
- Saglik Bilimleri Universitesi
- 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".
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Head circumference in centimeters-T1 On the 3-month of CME diet Head circumference (cm)
Body weight in kilograms-T2 Three months after the end of the CME diet Body weight (kg)
Body weight in kilograms-T3 The last examination date of the patient after 3rd month control after CME diet Body weight (kg)
Body weight in kilograms-T1 On the 3-month of CME diet Body weight (kg)
Height in centimeters-T1 On the 3-month of CME diet Height (cm)
Head circumference in centimeters-T0 One month prior to the diagnosis of CMA Head circumference (cm)
Body weight in kilograms-T0 One month prior to the diagnosis of CMA Body weight (kg)
Height in centimeters-T2 Three months after the end of the CME diet Height (cm)
Head circumference in centimeters-T3 The last examination date of the patient after 3rd month control after CME diet Head circumference (cm)
Height in centimeters-T0 One month prior to the diagnosis of CMA Height (cm)
Height in centimeters-T3 The last examination date of the patient after 3rd month control after CME diet Height (cm)
Head circumference in centimeters-T2 Three months after the end of the CME diet Head circumference (cm)
- Secondary Outcome Measures
Name Time Method Blood measurements-Folate The last examination date of the patient after 3rd month control after CME diet Folate
Dietary intake The last examination date of the patient after 3rd month control after CME diet Three day dietary record
Blood measurements-Sodium The last examination date of the patient after 3rd month control after CME diet sodium mg/ml
Blood measurements-selenium The last examination date of the patient after 3rd month control after CME diet Selenium
Blood measurements-Hemoglobin The last examination date of the patient after 3rd month control after CME diet Hemoglobin g/dl
Blood measurements-Albumin The last examination date of the patient after 3rd month control after CME diet Albumin
Blood measurements-Potassium The last examination date of the patient after 3rd month control after CME diet Potassium
Blood measurements-zinc The last examination date of the patient after 3rd month control after CME diet Zinc
Blood measurements-iron The last examination date of the patient after 3rd month control after CME diet Iron
Blood measurements-Protein The last examination date of the patient after 3rd month control after CME diet Protein
Blood measurements-25-OH vitamin D The last examination date of the patient after 3rd month control after CME diet 25-OH vitamin D
Blood measurements-Calcium The last examination date of the patient after 3rd month control after CME diet Calcium
Blood measurements-Vitamin B12 The last examination date of the patient after 3rd month control after CME diet Vitamin B12
Trial Locations
- Locations (1)
University of Health Sciences, Gulhane Education and Research Hospital
🇹🇷Ankara, Turkey