Clinical trial NCT05151393: Correlation Between Serum Vitamin D3 and Incidence of Uterine Leiomyoma
Official title: Correlation Between Serum Vitamin D3 Level and Incidence of Uterine Leiomyoma in Egyptian Women
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vitamin D Deficiency
Leiomyoma
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 80
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief 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


Eligibility criteria: 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.

Primary outcomes:
measure: Low levels serum vitamin D as a risk factor for development of uterine leiomyoma.
timeFrame: 6 months
Secondary outcomes:
measure: Correlation of low serum vitamin D with size, site and number of fibroids
timeFrame: 6 months
measure: Correlation of low serum vitamin D with severity of symptoms related to uterine leiomyoma
timeFrame: 6 months
measure: Role of vitamin D deficiency in development of uterine leiomyoma in high risk groups (black race, obese patients).
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Ain Shams University
name: Rania Gamal, MD
role: STUDY_DIRECTOR
affiliation: Ain Shams University
name: Mortada Elsayed, MD
role: STUDY_DIRECTOR
affiliation: Ain Shams University
name: Aliaa Maaty, MD
role: STUDY_DIRECTOR
affiliation: AinShansU
name: Magdy Hassan, MD
role: STUDY_CHAIR
References:
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