Effect of Vitamin D3 Supplementation on Symptomatic Uteri... | NCT07012161

NCT07012161

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pt with uterine fibroid	Experimental	Study subjects will be selected according to inclusion and exclusion criteria, consents will be taken in informed written consent form, and then preceded as follow- 39 diagnosed women with uterine fibroid aged 18 to 50 years experiencing heavy menstrual bleeding will be purposively selected upon meeting the selection criteria Demographic information, medical history, clinical examination findings, and other relevant clinical data will be gathered through interviews Baseline Assessments: menstrual blood loss, hemoglobin concentration and ultrasound parameters (uterine volume, fibroid characteristics) Participants received 25(OH) Vitamin D3 orally	Drug: Colecalciferol (Vitamin D3) 50000 UI

Name	Type	Description	Arm Group Labels	Other Names
Colecalciferol (Vitamin D3) 50000 UI	Drug	Participants will received vit d upto 6 months	Pt with uterine fibroid

Measure	Description	Time Frame
Effect of Vitamin D3 supplementation on symptomatic uterine fibroid in women with Vitamin D deficiency.	Fibroid size by cm	18 months

Eligibility Module

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.