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

NCT05038995 | Unknown

• 1 other identifier: NzlKbr2021
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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".

Conditions

Cow Milk Allergy

Keywords

Cow milk allergy; Elimination diet; Anthropometry; Growth status

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (13)

• Dietary intake

  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-Sodium

  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-Albumin

  The last examination date of the patient after 3rd month control after CME diet

Study Arms (2)

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.

Eligibility Criteria

• Age: 1 Month - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Pediatric Allergy Department Outpatient Clinic and Healthy Child Outpatient Clinic

You may qualify if:

• 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.
• did not have CMA and other allergic diseases
• who had never been on a diet throughout their lives.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

University of Health Sciences, Gulhane Education and Research Hospital

Ankara, Turkey (Türkiye)

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Nazli Ercan, MD

  University of Health Sciences Turkey, Gulhane Education and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nazlı Ercan, MD

CONTACT

+905319957255; drnazliercan@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: September 9, 2021
• Study Start: April 1, 2021
• Primary Completion: September 20, 2021
• Study Completion: September 20, 2021
• Last Updated: September 9, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)