Vitamin D DeficiencyNCT05151393
Correlation Between Serum Vitamin D3 and Incidence of Uterine Leiomyoma
An observational study of Vitamin D Deficiency and Leiomyoma, run by Ain Shams University.
Trial summary
The aim of the current study is to evaluate the association between low serum vitamin D level and incidence of uterine leiomyoma in Egyptian women as the research hypothesis that low serum vitamin D is considered a risk factor for uterine leiomyoma Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency, Leiomyoma
- What is being tested?
- Measuring vitamin D3 level
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 15 Feb 2022
- 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Study Population: (N=80) Women with symptomatic uterine fibroids attending the gynecology outpatient clinic and age matched controls free from uterine leiomyoma.
Who may be able to join
- Age ranging from 20 to 45 years.
- Postmenstrual patients to exclude current pregnancy.
- Parity up to para 3 by either normal vaginal delivery or cesarean section.
- Body mass index (BMI) ranging from 18 to 30 kg/m2.
- One or more uterine fibroid with a diameter ranging from 3-10 cm.
- Fibroids either subserous, intramural or submucous uterine fibroids
Who cannot join
- Women aged less than 20 years have a very low incidence of fibroids or more than 45 years as there is an increased incidence of vitamin D deficiency after this age.
- Patients known to be currently pregnant due to change in fibroids volume during pregnancy in addition to vitamin D levels may be lower than baseline for nonpregnant ones.
- Grand multipara >3 times frequently associated with vitamin D deficiency.
- Cardiac( e.g rheumatic heart diseases), pulmonary( e.g asthma, bronchiectasis ), or hematological disease (including anemia; hemoglobin level below 10gm/dl , thalassemia, sickle cell anemia, and spherocytosis) because of high association between chronic illnesses and multivitamin deficiency.
- Patients who receive pre-operative hormonal therapy (such as GnRH analogue) which may increase vitamin D levels and interfere with the study objectives.
- Patients who will present with a suspected malignant gynecological disease which is usually associated with multiple vitamin deficiencies including vitamin D.
Show all 16Show fewer
- Patients who will be diagnosed as having cervical or supracervical fibroids and pedunculated fibroids (study will be limited on corporeal fibroid).
- Small fibroid less than 3cm diameter may not be enough size to cause changes in lab results or large ones more than 10 cm diameter.
- Previous myomectomy or hysterectomy.
- Using vitamin supplements or hormonal therapy during or within 6 months of enrolment which may interfere with the accurate results of the study.
- Current lactating or lactating within 6 months prior to enrollment as breastfeeding women have a significantly higher prevalence of vitamin D deficiency.
- Current smokers or history of smoking as it decreases the production of the active form of vitamin D.
- Steroids intake as it increases the 24-hydroxylase level causing vitamin D deficiency.
- Cases diagnosed with any form of malignancy that may be associated with vitamin D deficiency.
- Current treatment with heparin as it interferes with vitamin D activation.
- Patients currently on depo-medroxyprogesterone-acetate (DMPA) contraceptives as it proved benefits in shrinking fibroid size.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Correlation Between Serum Vitamin D3 Level and Incidence of Uterine Leiomyoma in Egyptian Women
The aim of the current study is to evaluate the association between low serum vitamin D level and incidence of uterine leiomyoma in Egyptian women as the research hypothesis that low serum vitamin D is considered a risk factor for uterine leiomyoma
- Conditions
- Vitamin D Deficiency, Leiomyoma
- Being tested
- Measuring vitamin D3 level
- Medical subject headings
- Vitamin D Deficiency, Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measuring vitamin D3 levelDiagnostic test
Measuring vitamin D3 in both groups
| Study group | Role | What they receive |
|---|---|---|
| Cases | Cases with uterine leiomyoma Receives: Diagnostic Test: Measuring vitamin D3 level | |
| Controls | Cases free of uterine leiomyoma Receives: Diagnostic Test: Measuring vitamin D3 level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low levels serum vitamin D as a risk factor for development of uterine leiomyoma.
Low levels serum vitamin D as a risk factor for development of uterine leiomyoma.
Measured: 6 months
Secondary outcomes (3)
Correlation of low serum vitamin D with size, site and number of fibroids
Correlation of low serum vitamin D with size, site and number of fibroids
Measured: 6 months
Correlation of low serum vitamin D with severity of symptoms related to uterine leiomyoma
Correlation of low serum vitamin D with severity of symptoms related to uterine leiomyoma
Measured: 6 months
Role of vitamin D deficiency in development of uterine leiomyoma in high risk groups (black race, obese patients).
Role of vitamin D deficiency in development of uterine leiomyoma in high risk groups (black race, obese patients).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start1 Dec 2021 (estimated)
- Primary completion28 Jan 2022 (estimated)
- Study completion15 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Samy, Ain Shams University
- Investigators
- Rania Gamal, MD, Study director, Ain Shams UniversityMortada Elsayed, MD, Study director, Ain Shams UniversityAliaa Maaty, MD, Study director, Ain Shams UniversityMagdy Hassan, MD, Study chair, AinShansU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05151393
- Sponsor's protocol ID
- VitaminD and Uterine leiomyoma
- Status last verified
- Nov 2021
- First submitted
- 24 Aug 2021
- Last updated
- 9 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Corachan A, Ferrero H, Escrig J, Monleon J, Faus A, Cervello I, Pellicer A. Long-term vitamin D treatment decreases human uterine leiomyoma size in a xenograft animal model. Fertil Steril. 2020 Jan;113(1):205-216.e4. doi: 10.1016/j.fertnstert.2019.09.018. Epub 2019 Nov 15.
PubMed 31739978Bouillon R, Carmeliet G. Vitamin D insufficiency: Definition, diagnosis and management. Best Pract Res Clin Endocrinol Metab. 2018 Oct;32(5):669-684. doi: 10.1016/j.beem.2018.09.014. Epub 2018 Oct 3.
PubMed 30449548Ciavattini A, Clemente N, Delli Carpini G, Di Giuseppe J, Giannubilo SR, Tranquilli AL. Number and size of uterine fibroids and obstetric outcomes. J Matern Fetal Neonatal Med. 2015 Mar;28(4):484-8. doi: 10.3109/14767058.2014.921675. Epub 2014 Jun 5.
PubMed 24803127Ciebiera M, Ali M, Zgliczynska M, Skrzypczak M, Al-Hendy A. Vitamins and Uterine Fibroids: Current Data on Pathophysiology and Possible Clinical Relevance. Int J Mol Sci. 2020 Aug 1;21(15):5528. doi: 10.3390/ijms21155528.
PubMed 32752274Drayer SM, Catherino WH. Prevalence, morbidity, and current medical management of uterine leiomyomas. Int J Gynaecol Obstet. 2015 Nov;131(2):117-22. doi: 10.1016/j.ijgo.2015.04.051. Epub 2015 Aug 5.
PubMed 26275638Mas A, Tarazona M, Dasi Carrasco J, Estaca G, Cristobal I, Monleon J. Updated approaches for management of uterine fibroids. Int J Womens Health. 2017 Sep 5;9:607-617. doi: 10.2147/IJWH.S138982. eCollection 2017.
PubMed 28919823Mettler L, Schollmeyer T, Tinelli A, Malvasi A, Alkatout I. Complications of Uterine Fibroids and Their Management, Surgical Management of Fibroids, Laparoscopy and Hysteroscopy versus Hysterectomy, Haemorrhage, Adhesions, and Complications. Obstet Gynecol Int. 2012;2012:791248. doi: 10.1155/2012/791248. Epub 2012 Apr 9.
PubMed 22619681Matsui MS. Vitamin D Update. Curr Dermatol Rep. 2020;9(4):323-330. doi: 10.1007/s13671-020-00315-0. Epub 2020 Oct 14.
PubMed 33078087Sheng B, Song Y, Liu Y, Jiang C, Zhu X. Association between vitamin D and uterine fibroids: a study protocol of an open-label, randomised controlled trial. BMJ Open. 2020 Nov 6;10(11):e038709. doi: 10.1136/bmjopen-2020-038709.
PubMed 33158822Singh V, Barik A, Imam N. Vitamin D3 Level in Women with Uterine Fibroid: An Observational Study in Eastern Indian Population. J Obstet Gynaecol India. 2019 Apr;69(2):161-165. doi: 10.1007/s13224-018-1195-4. Epub 2018 Dec 6.
PubMed 30956471Sirajudeen S, Shah I, Al Menhali A. A Narrative Role of Vitamin D and Its Receptor: With Current Evidence on the Gastric Tissues. Int J Mol Sci. 2019 Aug 5;20(15):3832. doi: 10.3390/ijms20153832.
PubMed 31387330Srivastava P, Gupta HP, Singhi S, Khanduri S, Rathore B. Evaluation of 25-hydroxy vitamin D3 levels in patients with a fibroid uterus. J Obstet Gynaecol. 2020 Jul;40(5):710-714. doi: 10.1080/01443615.2019.1654986. Epub 2019 Oct 22.
PubMed 31635506Stewart EA, Cookson CL, Gandolfo RA, Schulze-Rath R. Epidemiology of uterine fibroids: a systematic review. BJOG. 2017 Sep;124(10):1501-1512. doi: 10.1111/1471-0528.14640. Epub 2017 May 13.
PubMed 28296146Szkodziak P, Pyra K, Szkodziak F, Krzyzanowski J, Czuczwar P, Wozniak S, Jargiello T, Paszkowski T. The Lublin Protocol of the Uterine Arteries Embolization in the Treatment of Symptomatic Uterine Fibroids. J Vis Exp. 2020 Sep 15;(163). doi: 10.3791/61530.
PubMed 33016950
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Serum Vitamin D3 Level and Incidence of Uterine Leiomyoma in Egyptian Women
- ClinicalTrials.gov ID
- NCT05151393
- Acronym / sponsor ID
- VitaminD and Uterine leiomyoma
- Conditions
- Vitamin D Deficiency, Leiomyoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 28 Jan 2022 (estimated)
- Study completion
- 15 Feb 2022 (estimated)
- First posted
- 9 Dec 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.
The aim of the current study is to evaluate the association between low serum vitamin D level and incidence of uterine leiomyoma in Egyptian women as the research hypothesis that low serum vitamin D is considered a risk factor for uterine leiomyoma
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Diagnostic Test: Measuring vitamin D3 levelCases with uterine leiomyoma |
| Controls | – | Diagnostic Test: Measuring vitamin D3 levelCases free of uterine leiomyoma |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Study Population: (N=80) Women with symptomatic uterine fibroids attending the gynecology outpatient clinic and age matched controls free from uterine leiomyoma.
Key inclusion criteria (6 listed)
- Age ranging from 20 to 45 years.
- Postmenstrual patients to exclude current pregnancy.
- Parity up to para 3 by either normal vaginal delivery or cesarean section.
- Body mass index (BMI) ranging from 18 to 30 kg/m2.
- One or more uterine fibroid with a diameter ranging from 3-10 cm.
Key exclusion criteria (16 listed)
- Women aged less than 20 years have a very low incidence of fibroids or more than 45 years as there is an increased incidence of vitamin D deficiency after this age.
- Patients known to be currently pregnant due to change in fibroids volume during pregnancy in addition to vitamin D levels may be lower than baseline for nonpregnant ones.
- Grand multipara >3 times frequently associated with vitamin D deficiency.
- Cardiac( e.g rheumatic heart diseases), pulmonary( e.g asthma, bronchiectasis ), or hematological disease (including anemia; hemoglobin level below 10gm/dl , thalassemia, sickle cell anemia, and spherocytosis) because of high association between chronic illnesses and multivitamin deficiency.
- Patients who receive pre-operative hormonal therapy (such as GnRH analogue) which may increase vitamin D levels and interfere with the study objectives.
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 |
|---|---|---|
| Measuring vitamin D3 levelMeasuring vitamin D3 in both groups | Diagnostic test | Cases, Controls |
Primary outcome
Low levels serum vitamin D as a risk factor for development of uterine leiomyoma.
Time frame: 6 months
Low levels serum vitamin D as a risk factor for development of uterine leiomyoma.
3 secondary outcomes
Correlation of low serum vitamin D with size, site and number of fibroids
Time frame: 6 months
Correlation of low serum vitamin D with severity of symptoms related to uterine leiomyoma
Time frame: 6 months
Role of vitamin D deficiency in development of uterine leiomyoma in high risk groups (black race, obese patients).
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
- Background: PubMed 31739978Corachan A, Ferrero H, Escrig J, Monleon J, Faus A, Cervello I, Pellicer A. Long-term vitamin D treatment decreases human uterine leiomyoma size in a xenograft animal model. Fertil Steril. 2020 Jan;113(1):205-216.e4. doi: 10.1016/j.fertnstert.2019.09.018. Epub 2019 Nov 15.
- Background: PubMed 30449548Bouillon R, Carmeliet G. Vitamin D insufficiency: Definition, diagnosis and management. Best Pract Res Clin Endocrinol Metab. 2018 Oct;32(5):669-684. doi: 10.1016/j.beem.2018.09.014. Epub 2018 Oct 3.
- Background: PubMed 24803127Ciavattini A, Clemente N, Delli Carpini G, Di Giuseppe J, Giannubilo SR, Tranquilli AL. Number and size of uterine fibroids and obstetric outcomes. J Matern Fetal Neonatal Med. 2015 Mar;28(4):484-8. doi: 10.3109/14767058.2014.921675. Epub 2014 Jun 5.
- Background: PubMed 32752274Ciebiera M, Ali M, Zgliczynska M, Skrzypczak M, Al-Hendy A. Vitamins and Uterine Fibroids: Current Data on Pathophysiology and Possible Clinical Relevance. Int J Mol Sci. 2020 Aug 1;21(15):5528. doi: 10.3390/ijms21155528.
- Background: PubMed 26275638Drayer SM, Catherino WH. Prevalence, morbidity, and current medical management of uterine leiomyomas. Int J Gynaecol Obstet. 2015 Nov;131(2):117-22. doi: 10.1016/j.ijgo.2015.04.051. Epub 2015 Aug 5.
- Background: PubMed 28919823Mas A, Tarazona M, Dasi Carrasco J, Estaca G, Cristobal I, Monleon J. Updated approaches for management of uterine fibroids. Int J Womens Health. 2017 Sep 5;9:607-617. doi: 10.2147/IJWH.S138982. eCollection 2017.
- Background: PubMed 22619681Mettler L, Schollmeyer T, Tinelli A, Malvasi A, Alkatout I. Complications of Uterine Fibroids and Their Management, Surgical Management of Fibroids, Laparoscopy and Hysteroscopy versus Hysterectomy, Haemorrhage, Adhesions, and Complications. Obstet Gynecol Int. 2012;2012:791248. doi: 10.1155/2012/791248. Epub 2012 Apr 9.
- Background: PubMed 33078087Matsui MS. Vitamin D Update. Curr Dermatol Rep. 2020;9(4):323-330. doi: 10.1007/s13671-020-00315-0. Epub 2020 Oct 14.
- Background: PubMed 33158822Sheng B, Song Y, Liu Y, Jiang C, Zhu X. Association between vitamin D and uterine fibroids: a study protocol of an open-label, randomised controlled trial. BMJ Open. 2020 Nov 6;10(11):e038709. doi: 10.1136/bmjopen-2020-038709.
- Background: PubMed 30956471Singh V, Barik A, Imam N. Vitamin D3 Level in Women with Uterine Fibroid: An Observational Study in Eastern Indian Population. J Obstet Gynaecol India. 2019 Apr;69(2):161-165. doi: 10.1007/s13224-018-1195-4. Epub 2018 Dec 6.
- Background: PubMed 31387330Sirajudeen S, Shah I, Al Menhali A. A Narrative Role of Vitamin D and Its Receptor: With Current Evidence on the Gastric Tissues. Int J Mol Sci. 2019 Aug 5;20(15):3832. doi: 10.3390/ijms20153832.
- Background: PubMed 31635506Srivastava P, Gupta HP, Singhi S, Khanduri S, Rathore B. Evaluation of 25-hydroxy vitamin D3 levels in patients with a fibroid uterus. J Obstet Gynaecol. 2020 Jul;40(5):710-714. doi: 10.1080/01443615.2019.1654986. Epub 2019 Oct 22.
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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.
Rania Gamal, MD study director
Ain Shams University
Mortada Elsayed, MD study director
Ain Shams University
Aliaa Maaty, MD study director
Ain Shams University
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Deficiency and Leiomyoma, run by Ain Shams University.
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 6 inclusion and 16 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 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Mohamed Samy, Bachelor (00201141423818, dr.mohamed.tolis@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low levels serum vitamin D as a risk factor for development of uterine leiomyoma. (time frame: 6 months). 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 NCT05151393, which also lists 14 linked publications.
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 Dec 2021.