Ventricular Septal DefectNCT05200910
The Effect of Transcatheter VSD Closure on Children's Appetite, Hormones and Growth
An observational study of Ventricular Septal Defect and Appetite Loss, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study; Changes in appetite, hormones and growth of ventricular septal defect patients treated with non-surgical method were evaluated. Read more about this study
- Who is it for?
- Ages 3 months to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Ventricular Septal Defect, Appetite Loss, Growth Delay
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Jul 2018to 1 Jan 2020
- 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 3 months to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Pediatric patients who underwent transcatheter VSD closure in our institute and whose growth was followed for 6 months as patient group. Healthy children without appetite or growth retardation were included in the study as a control group.
Who may be able to join
- Pediatric patients who underwent transcatheter VSD closure
Who cannot join
- Chromosomal abnormalities
- Additional systemic disease
- Systemic infections
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional, Hormonal and Anthropometric Evaluation of Children After Transcatheter VSD Closure
In this study; Changes in appetite, hormones and growth of ventricular septal defect patients treated with non-surgical method were evaluated.
Read the detailed description
The study included 20 patients whose ventricular septal defect closed percutaneously and 26 children as control group. The symptoms, anthropometric measurements and laboratory tests of patient group were recorded at initial, 1st month and 6th months after closure.
Anthropometric measurements; weight for age (WFA), height for age (HFA), body mass index (BMI) and their z scores, triceps skinfold thickness (TSF) and mid-upper arm circumference (MUAC) were recorded on admission. Patients with weight for height z score less than -2 were defined as malnutrition.
Questions about the symptoms like appetite, weight gain, frequency of illness, rate of breathing, fatigue were asked to all parents at initial. These questionnaires15 and visual analogue scale (for appetite) were repeated at 1st and 6th month visits.
During the initial evaluation, approximately 6 ml of venous blood samples were taken between 9:00-10:00 am after an average of 10 hours fasting. On the same day, IGFBP-3, Ghrelin and leptin,fasting blood glucose, insulin, IGF-1, IGFBP-3, aspartate aminotransferase (AST) and alanine aminotransferase (ALT), total protein, and albumin were measured.
Anthropometric measurements and laboratory tests were repeated at 1st and 6th month visits.
- Conditions
- Ventricular Septal Defect, Appetite Loss, Growth Delay
- Keywords
- ventricular septal defect, appetite, growth, interventional therapy
- Medical subject headings
- Heart Septal Defects, Ventricular, Anorexia
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 |
|---|---|---|
| Patient | Patients whose ventricular septal defect closed percutaneously. | |
| Control | Healthy children |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Z score
The change in the Z scores of the heights according to the age of the patients after the interventional closure of the VSD
Measured: 6 months
Height Z score
The change in the Z scores of the heights according to the age of the patients after the interventional closure of the VSD
Measured: 6 month
Body mass index Z score
The change in the Z scores of the body mass index according to the age of the patients after the interventional closure of the VSD
Measured: 6 month
Ghrelin
Change in serum ghrelin level of patients after interventional closure of VSD
Measured: 6 month
Leptin
Change in serum leptin level of patients after interventional closure of VSD
Measured: 6 month
Visual analogue scale
Change in Visual analogue scale of patients and parent after interventional closure of VSD. Values in this scale vary between 0-100 mm, values close to '0' are composed of words and images expressing a decrease in the patient's appetite, values close to '100' representing an increase in appetite.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start16 Jul 2018
- Primary completion1 Jun 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular Septal DefectStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kayseri City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, süleyman sunkak, Kayseri City Hospital
- Investigators
- Onur Tasci, Principal investigator, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200910
- Sponsor's protocol ID
- 7645
- Status last verified
- Jan 2022
- First submitted
- 3 Dec 2021
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional, Hormonal and Anthropometric Evaluation of Children After Transcatheter VSD Closure
- ClinicalTrials.gov ID
- NCT05200910
- Acronym / sponsor ID
- 7645
- Conditions
- Ventricular Septal Defect, Appetite Loss, Growth Delay
- Keywords
- ventricular septal defect, appetite, growth, interventional therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Kayseri City HospitalOther government
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 21 Jan 2022 (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.
In this study; Changes in appetite, hormones and growth of ventricular septal defect patients treated with non-surgical method were evaluated.
Detailed description
The study included 20 patients whose ventricular septal defect closed percutaneously and 26 children as control group. The symptoms, anthropometric measurements and laboratory tests of patient group were recorded at initial, 1st month and 6th months after closure.
Anthropometric measurements; weight for age (WFA), height for age (HFA), body mass index (BMI) and their z scores, triceps skinfold thickness (TSF) and mid-upper arm circumference (MUAC) were recorded on admission. Patients with weight for height z score less than -2 were defined as malnutrition.
Questions about the symptoms like appetite, weight gain, frequency of illness, rate of breathing, fatigue were asked to all parents at initial. These questionnaires15 and visual analogue scale (for appetite) were repeated at 1st and 6th month visits.
During the initial evaluation, approximately 6 ml of venous blood samples were taken between 9:00-10:00 am after an average of 10 hours fasting. On the same day, IGFBP-3, Ghrelin and leptin,fasting blood glucose, insulin, IGF-1, IGFBP-3, aspartate aminotransferase (AST) and alanine aminotransferase (ALT), total protein, and albumin were measured.
Anthropometric measurements and laboratory tests were repeated at 1st and 6th month visits.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | – | –Patients whose ventricular septal defect closed percutaneously. |
| Control | – | –Healthy children |
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients who underwent transcatheter VSD closure in our institute and whose growth was followed for 6 months as patient group. Healthy children without appetite or growth retardation were included in the study as a control group.
Key inclusion criteria (1 listed)
- Pediatric patients who underwent transcatheter VSD closure
Key exclusion criteria (3 listed)
- Chromosomal abnormalities
- Additional systemic disease
- Systemic infections
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
Weight Z score
Time frame: 6 months
The change in the Z scores of the heights according to the age of the patients after the interventional closure of the VSD
Height Z score
Time frame: 6 month
The change in the Z scores of the heights according to the age of the patients after the interventional closure of the VSD
Body mass index Z score
Time frame: 6 month
The change in the Z scores of the body mass index according to the age of the patients after the interventional closure of the VSD
Ghrelin
Time frame: 6 month
Change in serum ghrelin level of patients after interventional closure of VSD
Leptin
Time frame: 6 month
Change in serum leptin level of patients after interventional closure of VSD
Visual analogue scale
Time frame: 6 month
Change in Visual analogue scale of patients and parent after interventional closure of VSD. Values in this scale vary between 0-100 mm, values close to '0' are composed of words and images expressing a decrease in the patient's appetite, values close to '100' representing an increase in appetite.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
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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.
Onur Tasci principal investigator
TC Erciyes University
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 Ventricular Septal Defect and Appetite Loss, run by Kayseri City Hospital 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 21 Jan 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Z score (time frame: 6 months). The study lists 6 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 21 Jan 2022.