Symptomatic Uterine FibroidEarly Phase 1NCT07012161
Effect of Vitamin D3 Supplementation on Symptomatic Uterine Fibroid in Women With Vitamin D Deficiency
A Early Phase 1 study testing Colecalciferol (Vitamin D3) 50000 UI in people with Symptomatic Uterine Fibroid, run by Nahida Akter at 2 sites in Bangladesh.
Trial summary
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.. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Symptomatic Uterine Fibroid
- What is being tested?
- Colecalciferol (Vitamin D3) 50000 UI
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesBangladesh
- Study dates
- 20 Feb 2025to Sep 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- .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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh2 sites, 2 recruiting
- Recruiting
Bangabandhu Sheikh Mujib medical university
Dhaka, Sahabag
- Recruiting
Bangabandhu Sheikh Mujib medical university
Dhaka
Prof.NurunNahar Khanam, Fcps,MS,DGO,MMED, +880 1713-017637
About this study
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..
Read the detailed description
Effects of vitamin D supplimentation on symptomatic uterine fibroid will be checked
- Conditions
- Symptomatic Uterine Fibroid
- Being tested
- Colecalciferol (Vitamin D3) 50000 UI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colecalciferol (Vitamin D3) 50000 UIDrug
Participants will received vit d upto 6 months
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Colecalciferol (Vitamin D3) 50000 UI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Vitamin D3 supplementation on symptomatic uterine fibroid in women with Vitamin D deficiency.
Fibroid size by cm
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start20 Feb 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Uterine FibroidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nahida Akter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nahida Akter, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07012161
- Sponsor's protocol ID
- 5256
- Status last verified
- May 2025
- First submitted
- 4 Apr 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D3 Supplementation on Symptomatic Uterine Fibroid in Women With Vitamin D Deficiency
- ClinicalTrials.gov ID
- NCT07012161
- Acronym / sponsor ID
- 5256
- Conditions
- Symptomatic Uterine Fibroid
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Nahida AkterUniversity, hospital or other
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pt with uterine fibroid | Experimental | Drug: Colecalciferol (Vitamin D3) 50000 UIStudy 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- .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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colecalciferol (Vitamin D3) 50000 UIParticipants will received vit d upto 6 months | Drug | Pt with uterine fibroid |
Primary outcome
Effect of Vitamin D3 supplementation on symptomatic uterine fibroid in women with Vitamin D deficiency.
Time frame: 18 months
Fibroid size by cm
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Colecalciferol (Vitamin D3) 50000 UI in people with Symptomatic Uterine Fibroid, run by Nahida Akter at 2 sites in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nahida Akter, MBBS (+8801635576296, nahidamili16@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Vitamin D3 supplementation on symptomatic uterine fibroid in women with Vitamin D deficiency. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.