Correlation Between Serum Vitamin D3 and Incidence of Uterine Leiomyoma

November 27, 2021 updated by: Mohamed Samy, Ain Shams University

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Study Population: (N=80) Women with symptomatic uterine fibroids attending the gynecology outpatient clinic and age matched controls free from uterine leiomyoma.

Description

Inclusion Criteria:

  1. Age ranging from 20 to 45 years.
  2. Postmenstrual patients to exclude current pregnancy.
  3. Parity up to para 3 by either normal vaginal delivery or cesarean section.
  4. Body mass index (BMI) ranging from 18 to 30 kg/m2.
  5. One or more uterine fibroid with a diameter ranging from 3-10 cm.
  6. Fibroids either subserous, intramural or submucous uterine fibroids

Exclusion Criteria:

  1. 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.
  2. 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.
  3. Grand multipara >3 times frequently associated with vitamin D deficiency.
  4. 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.
  5. Patients who receive pre-operative hormonal therapy (such as GnRH analogue) which may increase vitamin D levels and interfere with the study objectives.
  6. Patients who will present with a suspected malignant gynecological disease which is usually associated with multiple vitamin deficiencies including vitamin D.
  7. Patients who will be diagnosed as having cervical or supracervical fibroids and pedunculated fibroids (study will be limited on corporeal fibroid).
  8. 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.
  9. Previous myomectomy or hysterectomy.
  10. Using vitamin supplements or hormonal therapy during or within 6 months of enrolment which may interfere with the accurate results of the study.
  11. Current lactating or lactating within 6 months prior to enrollment as breastfeeding women have a significantly higher prevalence of vitamin D deficiency.
  12. Current smokers or history of smoking as it decreases the production of the active form of vitamin D.
  13. Steroids intake as it increases the 24-hydroxylase level causing vitamin D deficiency.
  14. Cases diagnosed with any form of malignancy that may be associated with vitamin D deficiency.
  15. Current treatment with heparin as it interferes with vitamin D activation.
  16. Patients currently on depo-medroxyprogesterone-acetate (DMPA) contraceptives as it proved benefits in shrinking fibroid size.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cases
Cases with uterine leiomyoma
Diagnostic test: Measuring vitamin D3 level
Measuring vitamin D3 in both groups
Controls
Cases free of uterine leiomyoma
Diagnostic test: Measuring vitamin D3 level
Measuring vitamin D3 in both groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of low serum vitamin D with size, site and number of fibroids
Time Frame: 6 months
Correlation of low serum vitamin D with size, site and number of fibroids
6 months
Correlation of low serum vitamin D with severity of symptoms related to uterine leiomyoma
Time Frame: 6 months
Correlation of low serum vitamin D with severity of symptoms related to uterine leiomyoma
6 months
Role of vitamin D deficiency in development of uterine leiomyoma in high risk groups (black race, obese patients).
Time Frame: 6 months
Role of vitamin D deficiency in development of uterine leiomyoma in high risk groups (black race, obese patients).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Director: Rania Gamal, MD, Ain Shams University
  • Study Director: Mortada Elsayed, MD, Ain Shams University
  • Study Director: Aliaa Maaty, MD, Ain Shams University
  • Study Chair: Magdy Hassan, MD, AinShansU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2021

Primary Completion (Anticipated)

January 28, 2022

Study Completion (Anticipated)

February 15, 2022

Study Registration Dates

First Submitted

August 24, 2021

First Submitted That Met QC Criteria

November 27, 2021

First Posted (Actual)

December 9, 2021

Study Record Updates

Last Update Posted (Actual)

December 9, 2021

Last Update Submitted That Met QC Criteria

November 27, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VitaminD and Uterine leiomyoma

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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