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:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2025-12-24 @ 12:38 PM
NCT ID:
NCT07012161
Eligibility Criteria:
Inclusion Criteria:
.Women aged between 18-50 not currently pregnant, lactating, or planning to conceive during the study period.
* Women with a confirmed diagnosis of uterine fibroids (leiomyoma) through ultrasound.
* Serum 25-hydroxyvitamin D \[25(OH)D\] levels below 20 ng/mL (indicating vitamin D deficiency).
* Presence of symptoms associated with uterine fibroid, such as menorrhagia (heavy menstrual bleeding), or bulk-related symptoms (e.g., urinary frequency).
* Participants should be generally healthy, with no history of other chronic illnesses that could affect the study's outcomes (e.g., autoimmune diseases, cancers, severe liver or kidney diseases).
* Willingness to provide written informed consent for participation in the study.
* No current use of hormonal therapy, other vitamin D supplements, or medications known to influence calcium metabolism or uterine fibroid growth (e.g., GnRH agonists, anti-estrogens).
* Participants must be willing and able to adhere to the study protocol, including attending follow-up visits and completing any required assessments or tests.
Exclusion Criteria:
* Women younger than 18 or older than 50 years.
* Serum 25-hydroxyvitamin D \[25(OH)D\] levels of 20 ng/mL or higher.
* Women without a confirmed diagnosis of uterine fibroids (leiomyoma) through imaging.
* Pregnant or breastfeeding women, or those planning to conceive during the study period.
* Presence of chronic illnesses such as autoimmune diseases, cancers, or severe liver or kidney disease that could interfere with the study's outcomes.
* Current or recent use of hormonal therapy, other vitamin D supplements, or medications that affect calcium metabolism or uterine fibroid growth (e.g., GnRH agonists, anti-estrogens).
* Women who have undergone surgical interventions (e.g., myomectomy, hysterectomy) or other medical treatments specifically for uterine fibroid within the past 6 months.
* Women with conditions like hyperparathyroidism or calcium disorders that might affect vitamin D metabolism or fibroid growth.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT07012161
Study Brief:
Protocol Section:
NCT07012161