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

September 3, 2021 updated by: Nazlı ERCAN, Saglik Bilimleri Universitesi

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Body weight in kilograms-T0
Time Frame: One month prior to the diagnosis of CMA
Body weight (kg)
One month prior to the diagnosis of CMA
Body weight in kilograms-T1
Time Frame: On the 3-month of CME diet
Body weight (kg)
On the 3-month of CME diet
Body weight in kilograms-T2
Time Frame: Three months after the end of the CME diet
Body weight (kg)
Three months after the end of the CME diet
Body weight in kilograms-T3
Time Frame: The last examination date of the patient after 3rd month control after CME diet
Body weight (kg)
The last examination date of the patient after 3rd month control after CME diet
Height in centimeters-T0
Time Frame: One month prior to the diagnosis of CMA
Height (cm)
One month prior to the diagnosis of CMA
Height in centimeters-T1
Time Frame: On the 3-month of CME diet
Height (cm)
On the 3-month of CME diet
Height in centimeters-T2
Time Frame: Three months after the end of the CME diet
Height (cm)
Three months after the end of the CME diet
Height in centimeters-T3
Time Frame: The last examination date of the patient after 3rd month control after CME diet
Height (cm)
The last examination date of the patient after 3rd month control after CME diet
Head circumference in centimeters-T0
Time Frame: One month prior to the diagnosis of CMA
Head circumference (cm)
One month prior to the diagnosis of CMA
Head circumference in centimeters-T1
Time Frame: On the 3-month of CME diet
Head circumference (cm)
On the 3-month of CME diet
Head circumference in centimeters-T2
Time Frame: Three months after the end of the CME diet
Head circumference (cm)
Three months after the end of the CME diet
Head circumference in centimeters-T3
Time Frame: The last examination date of the patient after 3rd month control after CME diet
Head circumference (cm)
The last examination date of the patient after 3rd month control after CME diet

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dietary intake
Time Frame: The last examination date of the patient after 3rd month control after CME diet
Three day dietary record
The last examination date of the patient after 3rd month control after CME diet
Blood measurements-Hemoglobin
Time Frame: The last examination date of the patient after 3rd month control after CME diet
Hemoglobin g/dl
The last examination date of the patient after 3rd month control after CME diet
Blood measurements-Sodium
Time Frame: The last examination date of the patient after 3rd month control after CME diet
sodium mg/ml
The last examination date of the patient after 3rd month control after CME diet
Blood measurements-Potassium
Time Frame: The last examination date of the patient after 3rd month control after CME diet
Potassium
The last examination date of the patient after 3rd month control after CME diet
Blood measurements-Albumin
Time Frame: The last examination date of the patient after 3rd month control after CME diet
Albumin
The last examination date of the patient after 3rd month control after CME diet
Blood measurements-Protein
Time Frame: The last examination date of the patient after 3rd month control after CME diet
Protein
The last examination date of the patient after 3rd month control after CME diet
Blood measurements-Calcium
Time Frame: The last examination date of the patient after 3rd month control after CME diet
Calcium
The last examination date of the patient after 3rd month control after CME diet
Blood measurements-Vitamin B12
Time Frame: The last examination date of the patient after 3rd month control after CME diet
Vitamin B12
The last examination date of the patient after 3rd month control after CME diet
Blood measurements-selenium
Time Frame: The last examination date of the patient after 3rd month control after CME diet
Selenium
The last examination date of the patient after 3rd month control after CME diet
Blood measurements-zinc
Time Frame: The last examination date of the patient after 3rd month control after CME diet
Zinc
The last examination date of the patient after 3rd month control after CME diet
Blood measurements-25-OH vitamin D
Time Frame: The last examination date of the patient after 3rd month control after CME diet
25-OH vitamin D
The last examination date of the patient after 3rd month control after CME diet
Blood measurements-iron
Time Frame: The last examination date of the patient after 3rd month control after CME diet
Iron
The last examination date of the patient after 3rd month control after CME diet
Blood measurements-Folate
Time Frame: The last examination date of the patient after 3rd month control after CME diet
Folate
The last examination date of the patient after 3rd month control after CME diet

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Saglik Bilimleri Universitesi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nazli Ercan, MD, University of Health Sciences Turkey, Gulhane Education and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 20, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 20, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 9, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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