The Effect of Early Cow's Milk Elimination Diet on the Growth Pattern and Nutritional Status of Preschool Children
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Head circumference in centimeters-T1
研究概览
简要总结
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".
详细描述
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".
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 1 Month 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Head circumference in centimeters-T1
时间窗: On the 3-month of CME diet
Head circumference (cm)
Body weight in kilograms-T2
时间窗: Three months after the end of the CME diet
Body weight (kg)
Body weight in kilograms-T3
时间窗: The last examination date of the patient after 3rd month control after CME diet
Body weight (kg)
Body weight in kilograms-T1
时间窗: On the 3-month of CME diet
Body weight (kg)
Height in centimeters-T1
时间窗: On the 3-month of CME diet
Height (cm)
Head circumference in centimeters-T0
时间窗: One month prior to the diagnosis of CMA
Head circumference (cm)
Body weight in kilograms-T0
时间窗: One month prior to the diagnosis of CMA
Body weight (kg)
Height in centimeters-T2
时间窗: Three months after the end of the CME diet
Height (cm)
Head circumference in centimeters-T3
时间窗: The last examination date of the patient after 3rd month control after CME diet
Head circumference (cm)
Height in centimeters-T0
时间窗: One month prior to the diagnosis of CMA
Height (cm)
Height in centimeters-T3
时间窗: The last examination date of the patient after 3rd month control after CME diet
Height (cm)
Head circumference in centimeters-T2
时间窗: Three months after the end of the CME diet
Head circumference (cm)
次要结局
- Dietary intake(The last examination date of the patient after 3rd month control after CME diet)
- Blood measurements-Sodium(The last examination date of the patient after 3rd month control after CME diet)
- Blood measurements-selenium(The last examination date of the patient after 3rd month control after CME diet)
- Blood measurements-Hemoglobin(The last examination date of the patient after 3rd month control after CME diet)
- Blood measurements-Albumin(The last examination date of the patient after 3rd month control after CME diet)
- Blood measurements-Folate(The last examination date of the patient after 3rd month control after CME diet)
- Blood measurements-Potassium(The last examination date of the patient after 3rd month control after CME diet)
- Blood measurements-zinc(The last examination date of the patient after 3rd month control after CME diet)
- Blood measurements-iron(The last examination date of the patient after 3rd month control after CME diet)
- Blood measurements-Protein(The last examination date of the patient after 3rd month control after CME diet)
- Blood measurements-25-OH vitamin D(The last examination date of the patient after 3rd month control after CME diet)
- Blood measurements-Calcium(The last examination date of the patient after 3rd month control after CME diet)
- Blood measurements-Vitamin B12(The last examination date of the patient after 3rd month control after CME diet)
研究者
Nazlı ERCAN
Principle investigator
Saglik Bilimleri Universitesi