Cow Milk AllergyNCT05038995
The Effect of Early Cow's Milk Elimination Diet on the Growth Pattern
An observational study of Cow Milk Allergy, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Cow Milk Allergy
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2021to 20 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Pediatric Allergy Department Outpatient Clinic and Healthy Child Outpatient Clinic
Who may be able to join
None listed.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
University of Health Sciences, Gulhane Education and Research Hospital
Ankara
Nazli Ercan, MD, +905319957255, drnazliercan@gmail.com
About this study
Official title: 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".
Read the 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".
- Conditions
- Cow Milk Allergy
- Keywords
- Cow milk allergy, Elimination diet, Anthropometry, Growth status
- Medical subject headings
- Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Body weight in kilograms-T0
Body weight (kg)
Measured: One month prior to the diagnosis of CMA
Body weight in kilograms-T1
Body weight (kg)
Measured: On the 3-month of CME diet
Body weight in kilograms-T2
Body weight (kg)
Measured: Three months after the end of the CME diet
Body weight in kilograms-T3
Body weight (kg)
Measured: The last examination date of the patient after 3rd month control after CME diet
Height in centimeters-T0
Height (cm)
Measured: One month prior to the diagnosis of CMA
Height in centimeters-T1
Height (cm)
Measured: On the 3-month of CME diet
Height in centimeters-T2
Height (cm)
Measured: Three months after the end of the CME diet
Height in centimeters-T3
Height (cm)
Measured: The last examination date of the patient after 3rd month control after CME diet
Head circumference in centimeters-T0
Head circumference (cm)
Measured: One month prior to the diagnosis of CMA
Head circumference in centimeters-T1
Head circumference (cm)
Measured: On the 3-month of CME diet
Head circumference in centimeters-T2
Head circumference (cm)
Measured: Three months after the end of the CME diet
Head circumference in centimeters-T3
Head circumference (cm)
Measured: The last examination date of the patient after 3rd month control after CME diet
Secondary outcomes (13)
Dietary intake
Three day dietary record
Measured: The last examination date of the patient after 3rd month control after CME diet
Blood measurements-Hemoglobin
Hemoglobin g/dl
Measured: The last examination date of the patient after 3rd month control after CME diet
Blood measurements-Sodium
sodium mg/ml
Measured: The last examination date of the patient after 3rd month control after CME diet
Blood measurements-Potassium
Potassium
Measured: The last examination date of the patient after 3rd month control after CME diet
Blood measurements-Albumin
Albumin
Measured: The last examination date of the patient after 3rd month control after CME diet
Blood measurements-Protein
Protein
Measured: The last examination date of the patient after 3rd month control after CME diet
Blood measurements-Calcium
Calcium
Measured: The last examination date of the patient after 3rd month control after CME diet
Blood measurements-Vitamin B12
Vitamin B12
Measured: The last examination date of the patient after 3rd month control after CME diet
Blood measurements-selenium
Selenium
Measured: The last examination date of the patient after 3rd month control after CME diet
Blood measurements-zinc
Zinc
Measured: The last examination date of the patient after 3rd month control after CME diet
Blood measurements-25-OH vitamin D
25-OH vitamin D
Measured: The last examination date of the patient after 3rd month control after CME diet
Blood measurements-iron
Iron
Measured: The last examination date of the patient after 3rd month control after CME diet
Blood measurements-Folate
Folate
Measured: The last examination date of the patient after 3rd month control after CME diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start1 Apr 2021
- Primary completion20 Sep 2021 (estimated)
- Study completion20 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cow Milk AllergyStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazlı ERCAN, Saglik Bilimleri Universitesi
- Investigators
- Nazli Ercan, MD, Principal investigator, University of Health Sciences Turkey, Gulhane Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05038995
- Sponsor's protocol ID
- NzlKbr2021
- Status last verified
- Aug 2021
- First submitted
- 19 Aug 2021
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Early Cow's Milk Elimination Diet on the Growth Pattern and Nutritional Status of Preschool Children
- ClinicalTrials.gov ID
- NCT05038995
- Acronym / sponsor ID
- NzlKbr2021
- Conditions
- Cow Milk Allergy
- Keywords
- Cow milk allergy, Elimination diet, Anthropometry, Growth status
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 20 Sep 2021 (estimated)
- Study completion
- 20 Sep 2021 (estimated)
- First posted
- 9 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 1 month to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Pediatric Allergy Department Outpatient Clinic and Healthy Child Outpatient Clinic
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Body weight in kilograms-T0
Time frame: One month prior to the diagnosis of CMA
Body weight (kg)
Body weight in kilograms-T1
Time frame: On the 3-month of CME diet
Body weight (kg)
Body weight in kilograms-T2
Time frame: Three months after the end of the CME diet
Body weight (kg)
Body weight in kilograms-T3
Time frame: The last examination date of the patient after 3rd month control after CME diet
Body weight (kg)
Height in centimeters-T0
Time frame: One month prior to the diagnosis of CMA
Height (cm)
Height in centimeters-T1
Time frame: On the 3-month of CME diet
Height (cm)
Height in centimeters-T2
Time frame: Three months after the end of the CME diet
Height (cm)
Height in centimeters-T3
Time frame: The last examination date of the patient after 3rd month control after CME diet
Height (cm)
Head circumference in centimeters-T0
Time frame: One month prior to the diagnosis of CMA
Head circumference (cm)
Head circumference in centimeters-T1
Time frame: On the 3-month of CME diet
Head circumference (cm)
Head circumference in centimeters-T2
Time frame: Three months after the end of the CME diet
Head circumference (cm)
Head circumference in centimeters-T3
Time frame: The last examination date of the patient after 3rd month control after CME diet
Head circumference (cm)
13 secondary outcomes
Dietary intake
Time frame: 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
Blood measurements-Sodium
Time frame: 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
Blood measurements-Albumin
Time frame: 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
Blood measurements-Calcium
Time frame: 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
Blood measurements-selenium
Time frame: 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
Blood measurements-25-OH vitamin D
Time frame: 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
Blood measurements-Folate
Time frame: The last examination date of the patient after 3rd month control after CME diet
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nazli Ercan, MD principal investigator
University of Health Sciences Turkey, Gulhane Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cow Milk Allergy, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nazlı Ercan, MD (+905319957255, drnazliercan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight in kilograms-T0 (time frame: One month prior to the diagnosis of CMA). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2021.