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

Cow Milk Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05038995
• Other study ID #: NzlKbr2021
• Status: Recruiting
• Start date: April 1, 2021
• Est. completion date: September 20, 2021

Study information

• Verified date: August 2021
• Source: Saglik Bilimleri Universitesi
• Contact: Nazli Ercan, MD
• Phone: +905319957255
• Email: drnazliercan[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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".

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 20, 2021
• Est. primary completion date: September 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cow Milk Allergy
• Milk Hypersensitivity

Locations

Country	Name	City	State
Turkey	University of Health Sciences, Gulhane Education and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight in kilograms-T0	Body weight (kg)	One month prior to the diagnosis of CMA
Primary	Body weight in kilograms-T1	Body weight (kg)	On the 3-month of CME diet
Primary	Body weight in kilograms-T2	Body weight (kg)	Three months after the end of the CME diet
Primary	Body weight in kilograms-T3	Body weight (kg)	The last examination date of the patient after 3rd month control after CME diet
Primary	Height in centimeters-T0	Height (cm)	One month prior to the diagnosis of CMA
Primary	Height in centimeters-T1	Height (cm)	On the 3-month of CME diet
Primary	Height in centimeters-T2	Height (cm)	Three months after the end of the CME diet
Primary	Height in centimeters-T3	Height (cm)	The last examination date of the patient after 3rd month control after CME diet
Primary	Head circumference in centimeters-T0	Head circumference (cm)	One month prior to the diagnosis of CMA
Primary	Head circumference in centimeters-T1	Head circumference (cm)	On the 3-month of CME diet
Primary	Head circumference in centimeters-T2	Head circumference (cm)	Three months after the end of the CME diet
Primary	Head circumference in centimeters-T3	Head circumference (cm)	The last examination date of the patient after 3rd month control after CME diet
Secondary	Dietary intake	Three day dietary record	The last examination date of the patient after 3rd month control after CME diet
Secondary	Blood measurements-Hemoglobin	Hemoglobin g/dl	The last examination date of the patient after 3rd month control after CME diet
Secondary	Blood measurements-Sodium	sodium mg/ml	The last examination date of the patient after 3rd month control after CME diet
Secondary	Blood measurements-Potassium	Potassium	The last examination date of the patient after 3rd month control after CME diet
Secondary	Blood measurements-Albumin	Albumin	The last examination date of the patient after 3rd month control after CME diet
Secondary	Blood measurements-Protein	Protein	The last examination date of the patient after 3rd month control after CME diet
Secondary	Blood measurements-Calcium	Calcium	The last examination date of the patient after 3rd month control after CME diet
Secondary	Blood measurements-Vitamin B12	Vitamin B12	The last examination date of the patient after 3rd month control after CME diet
Secondary	Blood measurements-selenium	Selenium	The last examination date of the patient after 3rd month control after CME diet
Secondary	Blood measurements-zinc	Zinc	The last examination date of the patient after 3rd month control after CME diet
Secondary	Blood measurements-25-OH vitamin D	25-OH vitamin D	The last examination date of the patient after 3rd month control after CME diet
Secondary	Blood measurements-iron	Iron	The last examination date of the patient after 3rd month control after CME diet
Secondary	Blood measurements-Folate	Folate	The last examination date of the patient after 3rd month control after CME diet

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