Correlation Between Serum Vitamin D3 and Incidence of Uterine Leiomyoma

Study Overview
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Brief Summary
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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

Official Title
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Correlation Between Serum Vitamin D3 Level and Incidence of Uterine Leiomyoma in Egyptian Women

Conditions
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Vitamin D Deficiency, Leiomyoma

Intervention / Treatment
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* Diagnostic Test: Measuring vitamin D3 level


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases<br>Cases with uterine leiomyoma | Diagnostic Test: Measuring vitamin D3 level<br>* Measuring vitamin D3 in both groups<br>|
| Controls<br>Cases free of uterine leiomyoma | Diagnostic Test: Measuring vitamin D3 level<br>* Measuring vitamin D3 in both groups<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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). | 6 months |