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

Saglik Bilimleri Universitesi

Status: Unknown

Conditions: Cow Milk Allergy

Study type: Observational

Funder types: Other

Identifiers

NCT05038995

NzlKbr2021

Details and patient eligibility

About

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".

Full 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".

Enrollment: 100 estimated patients

Sex: All

Ages: 1 month to 5 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

100 participants in 2 patient groups

Cow milk elimination group

Description:

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

Description:

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.