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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05038995
Enrollment
100
Registered
2021-09-09
Start date
2021-04-01
Completion date
2021-09-20
Last updated
2021-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cow Milk Allergy

Keywords

Cow milk allergy, Elimination diet, Anthropometry, Growth status

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.

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.

Interventions

None listed

Sponsors

Saglik Bilimleri Universitesi
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
1 Months to 5 Years
Healthy volunteers
Yes

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
Body weight in kilograms-T0One month prior to the diagnosis of CMABody weight (kg)
Body weight in kilograms-T1On the 3-month of CME dietBody weight (kg)
Body weight in kilograms-T2Three months after the end of the CME dietBody weight (kg)
Body weight in kilograms-T3The last examination date of the patient after 3rd month control after CME dietBody weight (kg)
Height in centimeters-T0One month prior to the diagnosis of CMAHeight (cm)
Height in centimeters-T1On the 3-month of CME dietHeight (cm)
Height in centimeters-T2Three months after the end of the CME dietHeight (cm)
Height in centimeters-T3The last examination date of the patient after 3rd month control after CME dietHeight (cm)
Head circumference in centimeters-T0One month prior to the diagnosis of CMAHead circumference (cm)
Head circumference in centimeters-T1On the 3-month of CME dietHead circumference (cm)
Head circumference in centimeters-T2Three months after the end of the CME dietHead circumference (cm)
Head circumference in centimeters-T3The last examination date of the patient after 3rd month control after CME dietHead circumference (cm)

Secondary

MeasureTime frameDescription
Blood measurements-ironThe last examination date of the patient after 3rd month control after CME dietIron
Blood measurements-FolateThe last examination date of the patient after 3rd month control after CME dietFolate
Blood measurements-Vitamin B12The last examination date of the patient after 3rd month control after CME dietVitamin B12
Blood measurements-seleniumThe last examination date of the patient after 3rd month control after CME dietSelenium
Blood measurements-zincThe last examination date of the patient after 3rd month control after CME dietZinc
Blood measurements-25-OH vitamin DThe last examination date of the patient after 3rd month control after CME diet25-OH vitamin D
Dietary intakeThe last examination date of the patient after 3rd month control after CME dietThree day dietary record
Blood measurements-HemoglobinThe last examination date of the patient after 3rd month control after CME dietHemoglobin g/dl
Blood measurements-SodiumThe last examination date of the patient after 3rd month control after CME dietsodium mg/ml
Blood measurements-PotassiumThe last examination date of the patient after 3rd month control after CME dietPotassium
Blood measurements-AlbuminThe last examination date of the patient after 3rd month control after CME dietAlbumin
Blood measurements-ProteinThe last examination date of the patient after 3rd month control after CME dietProtein
Blood measurements-CalciumThe last examination date of the patient after 3rd month control after CME dietCalcium

Countries

Turkey (Türkiye)

Contacts

Primary ContactNazlı Ercan, MD
drnazliercan@gmail.com+905319957255

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026