Vitamin D3 Supplementation for Women with Symptomatic Uterine Fibroid and Vitamin D Deficiency
Colecalciferol (Vitamin D3) 50000 UI
Treatment Study
Summary
Study start date: February 20, 2025
Actual date on which the first participant was enrolled.This study explores whether taking Vitamin D3 can help women who have both symptomatic uterine fibroids and a deficiency in Vitamin D. Uterine fibroids are non-cancerous growths in the uterus that can cause symptoms like heavy menstrual bleeding and pelvic pain. Many women with fibroids also have low levels of Vitamin D, and this study aims to see if increasing these levels with a supplement can relieve symptoms. This research could potentially offer a simple and non-invasive treatment option for women suffering from this condition. Participants in the study will receive Vitamin D3 supplements to see if their fibroid symptoms improve. The study does not specify how the medication is administered, but Vitamin D3 is typically taken orally. Researchers will observe the effects of the supplement on the symptoms of uterine fibroids. While specific risks or benefits are not mentioned, studies like this help determine if Vitamin D3 is a safe and effective treatment for reducing fibroid symptoms.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.39 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 18 to 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Bangabandhu Sheikh Mujib medical university
Dhaka, BangladeshOpen Bangabandhu Sheikh Mujib medical university in Google MapsBangabandhu Sheikh Mujib medical university
Dhaka, Bangladesh