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

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

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".

Study Overview

• Status: Recruiting
• Conditions: Cow Milk Allergy

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".

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Nazlı Ercan, MD; Phone Number: +905319957255; Email: drnazliercan@gmail.com

Study Locations

• Turkey
  • Ankara, Turkey
    • Recruiting
    • University of Health Sciences, Gulhane Education and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 5 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Pediatric Allergy Department Outpatient Clinic and Healthy Child Outpatient Clinic

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Cow milk elimination group; 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; 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?

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

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi
• Investigators: Principal Investigator: Nazli Ercan, MD, University of Health Sciences Turkey, Gulhane Education and Research Hospital

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2021
• Primary Completion (ANTICIPATED): September 20, 2021
• Study Completion (ANTICIPATED): September 20, 2021

Study Registration Dates

• First Submitted: August 19, 2021
• First Submitted That Met QC Criteria: September 3, 2021
• First Posted (ACTUAL): September 9, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 9, 2021
• Last Update Submitted That Met QC Criteria: September 3, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Anthropometry; Elimination diet; Cow milk allergy; Growth status
• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Milk Hypersensitivity
• Other Study ID Numbers: NzlKbr2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No