Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 1:12 AM
NCT ID:
NCT05151393
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.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
45 Years
Study:
NCT05151393
Study Brief:
Protocol Section:
NCT05151393