Recruiting NCT07012161
Effect of Vitamin D3 Supplementation on Symptomatic Uterine Fibroid in Women With Vitamin D Deficiency
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Colecalciferol (Vitamin D3) 50000 UI.
- Who it may be relevant to
- Registry conditions: Symptomatic Uterine Fibroid. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Bangladesh
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
39 women with symptomatic uterine fibroid with serum vitamin D deficiency will receive vitamin D3 supplementation for 6 month.then symptoms and size of fibroid will be re evaluated..
Detailed description
Effects of vitamin D supplimentation on symptomatic uterine fibroid will be checked
Interventions
- Drug Colecalciferol (Vitamin D3) 50000 UI
Participants will received vit d upto 6 months
Primary outcome measures
- Effect of Vitamin D3 supplementation on symptomatic uterine fibroid in women with Vitamin D deficiency. [Time frame: 18 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Bangladesh · 2 centers
- Bangabandhu Sheikh Mujib medical university — Dhaka
- Bangabandhu Sheikh Mujib medical university — Dhaka
Identifiers
NCT: NCT07012161 · 5256