Ignite Creation Date:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2025-12-27 @ 10:38 PM
Study NCT ID:
NCT05038995
Status:
UNKNOWN
Last Update Posted:
2021-09-09
First Post:
2021-08-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Early Cow's Milk Elimination Diet on the Growth Pattern
Sponsor:
Saglik Bilimleri Universitesi
Organization:
Study Overview
Official Title:
The Effect of Early Cow's Milk Elimination Diet on the Growth Pattern and Nutritional Status of Preschool Children
Status:
UNKNOWN
Status Verified Date:
2021-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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".
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: