Celiac DiseaseNCT04024449
Can Celiac Disease Affect Ovarian Function in Adolescent?
An observational study of Celiac Disease and Ovarian Failure, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
This case-control multicentre trial was performed from January 1, 2017, to May 31, 2018, in University of Health Sciences Bakirkoy Dr. Sadi Konuk Training and Research Hospital and Hitit University Hospital. Read more about this study
- Who is it for?
- Ages 13 to 20 years, women only
- Conditions the study is for
- Celiac Disease, Ovarian Failure
- What is being tested?
- Group A
- How many people
- 37 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2017to 31 May 2018
- How long will I take part?
- 28 Days
- 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 13 to 20 years
- Women only
- Child, Adult
Study population: The study population included 37 subjects in total. 20 people were in patients with celiac disease, 17 people were healthy adolescents.
Who may be able to join
- •Celiac disease and control group with 13 ≤ Age ≤20
- At least one year after menarche
Who cannot join
- delayed menarche, early puberty, delayed puberty, delayed development of secondary sexual characters due to another sexual disorder, obesity or malnutrition, Hyperandrogenism symptoms, and blood tests, Hyper or hypothyroidism, Hyperprolactinemia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Colyak Hastaliginin Puberte ve Sonrasinda Over Fonksiyonlarina Etkisinin Arastirilmasi
This case-control multicentre trial was performed from January 1, 2017, to May 31, 2018, in University of Health Sciences Bakirkoy Dr. Sadi Konuk Training and Research Hospital and Hitit University Hospital. Adolescents who were in compliance with the inclusion criteria were called by telephone for blood collection and ultrasound on the 3rd day of menstruation after approval from local ethical registration. On days 2-5 of the menstrual cycle, level of follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), prolactin (PRL), and AMH were measured from venous blood samples in both groups. Antral Follicle Counts (AFCs) and ovarian volumes were determined on the same day.
Read the detailed description
This case-control multicentre trial was performed from January 1, 2017, to May 31, 2018, in University of Health Sciences Bakirkoy Dr. Sadi Konuk Training and Research Hospital and Hitit University Hospital. This study was conducted with approval from the BTRH ethical board (number: 2018/166). This study covered 20 cases suffered from Celiac Disease and 18 were with regular menstrual period and healthy adolescent girls. Adolescents who were in compliance with the inclusion criteria were called by telephone for blood collection and ultrasound on the 3rd day of menstruation after approval from local ethical registration. Data on age, body mass index (BMI), levels of antitransglutaminase immune globulins A (IgA), positivity to antiendomysium IgA were recorded. On days 2-5 of the menstrual cycle, level of follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), prolactin (PRL), and AMH were measured from venous blood samples in both groups. The samples were centrifuged at 3,000 rpm for 10 minutes to aliquot the supernatants. Antral Follicle Counts (AFCs) and ovarian volumes were determined on the same day by the same ultrasound devices. The inclusion criteria included the following items;
- 13 ≤ Age ≤20
- At least one year after menarche
- Non-obesity or malnutrition, Non-Hyperandogenism symptoms, and blood tests, Non-Hyper or hypothyroidism, Non-Hyperprolactinemia.
- Control group; with a normal menstrual period, Non-chronic diseases The study had exclusion criteria such as delayed menarche, early puberty, delayed puberty, delayed development of secondary sexual characters due to another sexual disorder.
IBM SPSS version 22.0 (IBM Corp., Armonk, NY, USA) was used for all data analyses. Descriptive statistics are presented as numbers and percentages (%) for qualitative variables and as mean ± standard deviation and median (range) for quantitative variables. Normality distribution of data was evaluated using Kolmogorov-Smirnov, and Shapiro-Wilk tests to guide statistical test choice.
- Conditions
- Celiac Disease, Ovarian Failure
- Being tested
- Group A
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group AOther
Also called Celiac disease
ovarian function test in control group
| Study group | Role | What they receive |
|---|---|---|
| Celiac Disease | Celiac disease with the following criteria;
* 13 ≤ Age ≤20
* At least one year after menarche
* Non-obesity or malnutrition, Non-Hyperandogenism symptoms, and blood tests, Non-Hyper or hypothyroidism, Non-Hyperprolactinemia. Receives: Other: Group A | |
| Control | The adolescent with the following criteria;
* 13 ≤ Age ≤20
* At least one year after menarche
* Non-obesity or malnutrition, Non-Hyperandogenism symptoms, and blood tests, Non-Hyper or hypothyroidism, Non-Hyperprolactinemia.
* Control group; with normal menstrual period, Non-chronic diseases Receives: Other: Group A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti mullerian Hormone (AMH)
Level of AMH
Measured: on Day 3 menstruation
Follicle Situmulating Hormone (FSH)
Level of FSH
Measured: on Day 3 menstruation
Ovarian Volume
Ovarian volume measurement via Ultrasound
Measured: on Day 3 menstruation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start1 Jan 2017
- Primary completion1 Jan 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Celiac DiseaseStudies 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
- Cross-sectional
- Enrolment
- 37 participants (actual)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Atakan Comba, M.D., Study chair, Hitit University Department of Pediatric Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04024449
- Sponsor's protocol ID
- 2018/166
- Status last verified
- Jul 2019
- First submitted
- 10 Jul 2019
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: If the data is wanted, we will share data at any time.
Publications
Comba C, Comba A, Yilmaz H, Erdogan SV, Demir O. Celiac disease does not influence markers of ovarian reserve in adolescent girls. Arch Gynecol Obstet. 2020 Nov;302(5):1263-1269. doi: 10.1007/s00404-020-05666-4. Epub 2020 Jun 27.
PubMed 32594297
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colyak Hastaliginin Puberte ve Sonrasinda Over Fonksiyonlarina Etkisinin Arastirilmasi
- ClinicalTrials.gov ID
- NCT04024449
- Acronym / sponsor ID
- 2018/166
- Conditions
- Celiac Disease, Ovarian Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 18 Jul 2019 (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 case-control multicentre trial was performed from January 1, 2017, to May 31, 2018, in University of Health Sciences Bakirkoy Dr. Sadi Konuk Training and Research Hospital and Hitit University Hospital. Adolescents who were in compliance with the inclusion criteria were called by telephone for blood collection and ultrasound on the 3rd day of menstruation after approval from local ethical registration. On days 2-5 of the menstrual cycle, level of follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), prolactin (PRL), and AMH were measured from venous blood samples in both groups. Antral Follicle Counts (AFCs) and ovarian volumes were determined on the same day.
Detailed description
This case-control multicentre trial was performed from January 1, 2017, to May 31, 2018, in University of Health Sciences Bakirkoy Dr. Sadi Konuk Training and Research Hospital and Hitit University Hospital. This study was conducted with approval from the BTRH ethical board (number: 2018/166). This study covered 20 cases suffered from Celiac Disease and 18 were with regular menstrual period and healthy adolescent girls. Adolescents who were in compliance with the inclusion criteria were called by telephone for blood collection and ultrasound on the 3rd day of menstruation after approval from local ethical registration. Data on age, body mass index (BMI), levels of antitransglutaminase immune globulins A (IgA), positivity to antiendomysium IgA were recorded. On days 2-5 of the menstrual cycle, level of follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), prolactin (PRL), and AMH were measured from venous blood samples in both groups. The samples were centrifuged at 3,000 rpm for 10 minutes to aliquot the supernatants. Antral Follicle Counts (AFCs) and ovarian volumes were determined on the same day by the same ultrasound devices. The inclusion criteria included the following items;
- 13 ≤ Age ≤20
- At least one year after menarche
- Non-obesity or malnutrition, Non-Hyperandogenism symptoms, and blood tests, Non-Hyper or hypothyroidism, Non-Hyperprolactinemia.
- Control group; with a normal menstrual period, Non-chronic diseases The study had exclusion criteria such as delayed menarche, early puberty, delayed puberty, delayed development of secondary sexual characters due to another sexual disorder.
IBM SPSS version 22.0 (IBM Corp., Armonk, NY, USA) was used for all data analyses. Descriptive statistics are presented as numbers and percentages (%) for qualitative variables and as mean ± standard deviation and median (range) for quantitative variables. Normality distribution of data was evaluated using Kolmogorov-Smirnov, and Shapiro-Wilk tests to guide statistical test choice.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 28 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Celiac Disease | – | Other: Group ACeliac disease with the following criteria; * 13 ≤ Age ≤20 * At least one year after menarche * Non-obesity or malnutrition, Non-Hyperandogenism symptoms, and blood tests, Non-Hyper or hypothyroidism, Non-Hyperprolactinemia. |
| Control | – | Other: Group AThe adolescent with the following criteria; * 13 ≤ Age ≤20 * At least one year after menarche * Non-obesity or malnutrition, Non-Hyperandogenism symptoms, and blood tests, Non-Hyper or hypothyroidism, Non-Hyperprolactinemia. * Control group; with normal menstrual period, Non-chronic diseases |
Who may qualify
- Ages
- 13 to 20 years
- Sex
- Female only
- Age groups
- Child, Adult
- Study population
- The study population included 37 subjects in total. 20 people were in patients with celiac disease, 17 people were healthy adolescents.
Key inclusion criteria (2 listed)
- •Celiac disease and control group with 13 ≤ Age ≤20
Key exclusion criteria (1 listed)
- delayed menarche, early puberty, delayed puberty, delayed development of secondary sexual characters due to another sexual disorder, obesity or malnutrition, Hyperandrogenism symptoms, and blood tests, Hyper or hypothyroidism, Hyperprolactinemia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group AAlso: Celiac diseaseovarian function test in control group | Other | Celiac Disease, Control |
Primary outcome
Anti mullerian Hormone (AMH)
Time frame: on Day 3 menstruation
Level of AMH
Follicle Situmulating Hormone (FSH)
Time frame: on Day 3 menstruation
Level of FSH
Ovarian Volume
Time frame: on Day 3 menstruation
Ovarian volume measurement via Ultrasound
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 18 Jul 2019.
- Derived from this study: PubMed 32594297Comba C, Comba A, Yilmaz H, Erdogan SV, Demir O. Celiac disease does not influence markers of ovarian reserve in adolescent girls. Arch Gynecol Obstet. 2020 Nov;302(5):1263-1269. doi: 10.1007/s00404-020-05666-4. Epub 2020 Jun 27.
- Individual participant dataSharing planned: Yes. If the data is wanted, we will share data at any time.
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Pancreatic Ductal Adenocarcinoma (PDAC)
Enrolling by invitation
Assessment of Nutritional Status in Celiac Disease Using Muscle Ultrasound in Pediatric Patients.
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Celiac Disease in Childhood-Adulthood Transition
Celiac Disease, Celiac Disease in Children
Recruiting
GF-NOURISH (Gluten Free Nutrition Optimization Through Ultra-processed Food Reduction and Improved Strategies for Health)
Celiac Disease in Children, Nutrition Disorder, Child
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.
Atakan Comba, M.D. study chair
Hitit University Department of Pediatric Gastroenterology
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 Celiac Disease and Ovarian Failure, run by Bakirkoy Dr. Sadi Konuk Research and Training 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 2 inclusion and 1 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 18 Jul 2019. 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?
Anti mullerian Hormone (AMH) (time frame: on Day 3 menstruation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04024449, which also lists 1 linked publication.
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 18 Jul 2019.