The Study of Nutrition of Children and Adolescents With GERD
1 other identifier
interventional
219
1 country
1
Brief Summary
This trial is to study the aspects of nutrition in children and adolescents with GERD compared to the sex and age-matched control group
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2019
CompletedFirst Submitted
Initial submission to the registry
December 15, 2019
CompletedFirst Posted
Study publicly available on registry
December 17, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedFebruary 8, 2022
January 1, 2022
2.5 years
December 15, 2019
January 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Energy value of the ration
value of mean daily consumption of the energy by food frequency questionnaire, kcal/day
An average of 1 year
total fat consumption
value of mean daily consumption of fats by food frequency questionnaire, G/day
An average of 1 year
total carbohydrate consumption
value of mean daily consumption of carbohydrates, by food frequency questionnaire, G/day
An average of 1 year
total protein consumption
value of mean daily consumption of protein by food frequency questionnaire, G/day
An average of 1 year
Dietary fibre consumption
value of mean daily consumption of dietary fibre, by food frequency questionnaire, G/day
An average of 1 year
Secondary Outcomes (5)
Total number of gastroesophageal refluxes
24-hours
Number of acid gastroesophageal refluxes
24-hours
Number of weak-acid gastroesophageal refluxes
24-hours
Number of high gastroesophageal refluxes
24-hours
Acid exposure time
24-hours
Study Arms (2)
Patients with GERD
OTHERThe data of Food frequency questionnaire (FFQ), 24-hours oesophageal pH-impedance examination, GERD-Q questionnaire to be performed in children and adolescents with GERD.
Control group
OTHERThe same examinations as in experimental group are to be performed in patients of the control group (no GERD according to the results of the examination): Food frequency questionnaire (FFQ), 24-hours oesophageal pH-impedance examination, GERD-Q questionnaire.
Interventions
Food frequency questionnaire to investigate differences in diet of children and adolescents with GERD compared to the age- and sex matched control group.
Eligibility Criteria
You may qualify if:
- Willingness to participate (written informed consent and consent from parents or legal representative according to the local law);
- Age 6 to 17 years old inclusive,
- Possibility to assess symptoms, data of the medical history and receive answers to the questions about usual diet.
You may not qualify if:
- history of abdominal surgery;
- presence of varicose veins of the stomach and/or the oesophagus either in medical history or found during the study;
- inability to tolerate at least one of the invasive procedures or lacking data of the other instrumental examinations required by protocol;
- general condition of the patient making impossible to perform all the examinations or when performing the procedures is not safe and reasonable based on the opinion of the investigator that it may exacerbate the disease flow or put the patient at risk;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Moscow, 115446, Russia
Related Publications (1)
Borodina G, Morozov S. Children With Gastroesophageal Reflux Disease Consume More Calories and Fat Compared to Controls of Same Weight and Age. J Pediatr Gastroenterol Nutr. 2020 Jun;70(6):808-814. doi: 10.1097/MPG.0000000000002652.
PMID: 32443037DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dmitriy B Nikityuk, Professor
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
- STUDY CHAIR
Tatiana Strokova, Professor
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Leading researcher
Study Record Dates
First Submitted
December 15, 2019
First Posted
December 17, 2019
Study Start
January 1, 2017
Primary Completion
June 30, 2019
Study Completion
December 31, 2021
Last Updated
February 8, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- upon study completion. Available for 2 years according to the local low
- Access Criteria
- by request
Data may be shared by the request. No personal data of the participants is a subject for sharing.