Gynaecological DiseaseNCT03584529
Association Between Vitamin D and the Development of Uterine Fibroids
A study testing Vitamin D 3 in people with Gynaecological Disease and Vitamin D Deficiency, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
the aim of this randomised clinical trial study is to evaluate whether supplementation with vitamin D could inhibit the growth of uterine fibroids in reproductive stage women. Read more about this study
- Who is it for?
- Ages 35 to 50 years, women only
- Conditions the study is for
- Gynaecological Disease, Vitamin D Deficiency
- What is being tested?
- Vitamin D 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2018to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 1. Patients are willing to cooperate with the follow-up and sign informed consent;
- 2. Females aged 35-50 who are diagnosed as having uterine fibroids by transvaginal or abdominal ultrasonography;
- 3. The maximum average diameter of intramural myoma is ≤ 4cm，≥ 1cm; The amount of myoma is less than 4;
- 4. Serum 25-hydroxyvitamin D3 < 30 ng/ml, ≥ 12 ng/ml.
Who cannot join
- 1. Patients with heavy menstrual bleeding (>80.0 mL), menstrual disorders, pelvic discomfort, infertility, or other indications for operation;
- 2. Patients complicated with myoma degeneration and adenomyosis that were suspected or diagnosed by ultrasound or gynecologic examination;
- 3. Allergic to vitamin D3;
- 4. Use of sexual hormone, mifepristone, gonadotropin-releasing hormone agonist (GnRHa), or other medication which is likely to interfere with uterine fibroids within 3 months;
- 5. Pregnancy, lactation, postmenopause, or planned pregnancy within two years;
- 6. Suspected or identified as other tumors of genital tract;
Show all 12Show fewer
- 7. History of osteoporosis or vitamin D deficiency taking vitamin D supplements within previous one month;
- 8. History of autoimmune diseases, infectious diseases (tuberculosis, AIDS), autoimmune diseases, digestive system diseases (malabsorption, crohn disease, and dysentery);
- 9. Alanine aminotransferase (ALT) or aspartate transaminase(AST) more than 3 times of the normal upper limit, total bilirubin (TBIL) more than 2 times of the normal upper limit;
- 10. Creatinine levels≥1.4 mg/dL (123μmol/L) or creatinine clearance ≤ 50 mL/min;
- 11. History of malignant tumors;
- 12. Simultaneous participation in another clinical study with investigational medicinal product(s) or researcher thinks the subjects are not suitable for this trial.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
TING LI, feclinicalresearch@163.com
About this study
the aim of this randomised clinical trial study is to evaluate whether supplementation with vitamin D could inhibit the growth of uterine fibroids in reproductive stage women.
Read the detailed description
180 patients with vitamin D deficiency (12 ng/ml ≤ serum 25-hydroxyvitamin D3 < 20 ng/ml) and uterine fibroids will be randomly assigned in a ratio of 1:1 to two groups: intervention group A and control group B. 180 patients with vitamin D insufficiency (20 ng/ml ≤ serum 25-hydroxyvitamin D3 < 30 ng/ml) and uterine fibroids will be also randomly assigned in a ratio of 1:1 to two groups: intervention group C and control group D. The intervention group A will receive 1600 IU/d of vitamin D3; The intervention group C will receive 800 IU/d of vitamin D3; the control group B and the control group D will receive regular follow-up. Patients will be followed up at the same time points for 24 months. The outcome measure is the growth of uterine fibroids in different groups.
- Conditions
- Gynaecological Disease, Vitamin D Deficiency
- Being tested
- Vitamin D 3
- Medical subject headings
- Genital Diseases, Female, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D 3Drug
Non-Vitamin D3 Drops group Patients in this group would take nothing.
| Study group | Role | What they receive |
|---|---|---|
| vitamin D deficiency treatment group | Experimental | patients with vitamin D deficiency (12 ng/ml ≤ serum 25-hydroxyvitamin D3 < 20 ng/ml)and uterine fibroids receive 1600 IU/day of vitamin D3 oral capsule for two years Receives: Drug: Vitamin D 3 |
| vitamin D deficiency control group | No intervention | patients with vitamin D deficiency (12 ng/ml ≤ serum 25-hydroxyvitamin D3 < 20 ng/ml)and uterine fibroids receive regular follow-up. |
| vitamin D insufficiency treatment group | Experimental | patients with vitamin D insufficiency (20 ng/ml ≤ serum 25-hydroxyvitamin D3 < 30 ng/ml) and uterine fibroids receive 800 IU/d of vitamin D3 Receives: Drug: Vitamin D 3 |
| vitamin D insufficiency control group | No intervention | patients with vitamin D insufficiency (20 ng/ml ≤ serum 25-hydroxyvitamin D3 < 30 ng/ml)and uterine fibroids receive regular follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
volume of the total fibroids
percent change in volume of the largest fibroid compared to baseline in different groups
Measured: two years after treatment
Secondary outcomes (8)
percentage of subjects undergoing other medical or surgical treatment of uterine fibroids
percentage of subjects undergoing other medical or surgical treatment of uterine fibroids
Measured: two years after treatment
Hypercalcemia
The level of serum calcium > 2.5 mmol/L
Measured: Two years after treatment
abnormal liver function
Alanine aminotransferase (ALT) or aspartate transaminase (AST) more than 3 times of the normal upper limit, total bilirubin (TBIL) more than 2 times of the normal upper limit
Measured: Two years after treatment
urinary calculus
urinary calculus
Measured: Two years after treatment
abnormal renal function
Creatinine levels ≧ 1.4 mg/dL (123μmol/L) or creatinine clearance ≦ 50 mL/min
Measured: Two years after treatment
volume of the largest fibroid
percent change in volume of the largest fibroid compared to baseline in different groups
Measured: One year after treatment
volume of the total fibroids
percent change in volume of the total fibroids compared to baseline in different groups
Measured: One year after treatment
volume of the largest fibroid
percent change in volume of the largest fibroid compared to baseline in different groups
Measured: two years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start15 Sep 2018 (estimated)
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gynaecological DiseaseStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03584529
- Sponsor's protocol ID
- SAHoWMU-CR2017-07-126
- Status last verified
- Jul 2018
- First submitted
- 13 Jun 2018
- Last updated
- 5 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Sheng B, Song Y, Liu Y, Jiang C, Zhu X. Association between vitamin D and uterine fibroids: a study protocol of an open-label, randomised controlled trial. BMJ Open. 2020 Nov 6;10(11):e038709. doi: 10.1136/bmjopen-2020-038709.
PubMed 33158822
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Vitamin D and the Development of Uterine Fibroids
- ClinicalTrials.gov ID
- NCT03584529
- Acronym / sponsor ID
- SAHoWMU-CR2017-07-126
- Conditions
- Gynaecological Disease, Vitamin D Deficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 15 Sep 2018 (estimated)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 12 Jul 2018 (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.
the aim of this randomised clinical trial study is to evaluate whether supplementation with vitamin D could inhibit the growth of uterine fibroids in reproductive stage women.
Detailed description
180 patients with vitamin D deficiency (12 ng/ml ≤ serum 25-hydroxyvitamin D3 < 20 ng/ml) and uterine fibroids will be randomly assigned in a ratio of 1:1 to two groups: intervention group A and control group B. 180 patients with vitamin D insufficiency (20 ng/ml ≤ serum 25-hydroxyvitamin D3 < 30 ng/ml) and uterine fibroids will be also randomly assigned in a ratio of 1:1 to two groups: intervention group C and control group D. The intervention group A will receive 1600 IU/d of vitamin D3; The intervention group C will receive 800 IU/d of vitamin D3; the control group B and the control group D will receive regular follow-up. Patients will be followed up at the same time points for 24 months. The outcome measure is the growth of uterine fibroids in different groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| vitamin D deficiency treatment group | Experimental | Drug: Vitamin D 3patients with vitamin D deficiency (12 ng/ml ≤ serum 25-hydroxyvitamin D3 < 20 ng/ml)and uterine fibroids receive 1600 IU/day of vitamin D3 oral capsule for two years |
| vitamin D deficiency control group | No intervention | –patients with vitamin D deficiency (12 ng/ml ≤ serum 25-hydroxyvitamin D3 < 20 ng/ml)and uterine fibroids receive regular follow-up. |
| vitamin D insufficiency treatment group | Experimental | Drug: Vitamin D 3patients with vitamin D insufficiency (20 ng/ml ≤ serum 25-hydroxyvitamin D3 < 30 ng/ml) and uterine fibroids receive 800 IU/d of vitamin D3 |
| vitamin D insufficiency control group | No intervention | –patients with vitamin D insufficiency (20 ng/ml ≤ serum 25-hydroxyvitamin D3 < 30 ng/ml)and uterine fibroids receive regular follow-up. |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 1. Patients are willing to cooperate with the follow-up and sign informed consent;
- 2. Females aged 35-50 who are diagnosed as having uterine fibroids by transvaginal or abdominal ultrasonography;
- 3. The maximum average diameter of intramural myoma is ≤ 4cm，≥ 1cm; The amount of myoma is less than 4;
- 4. Serum 25-hydroxyvitamin D3 < 30 ng/ml, ≥ 12 ng/ml.
Key exclusion criteria (12 listed)
- 1. Patients with heavy menstrual bleeding (>80.0 mL), menstrual disorders, pelvic discomfort, infertility, or other indications for operation;
- 2. Patients complicated with myoma degeneration and adenomyosis that were suspected or diagnosed by ultrasound or gynecologic examination;
- 3. Allergic to vitamin D3;
- 4. Use of sexual hormone, mifepristone, gonadotropin-releasing hormone agonist (GnRHa), or other medication which is likely to interfere with uterine fibroids within 3 months;
- 5. Pregnancy, lactation, postmenopause, or planned pregnancy within two years;
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 |
|---|---|---|
| Vitamin D 3Non-Vitamin D3 Drops group Patients in this group would take nothing. | Drug | vitamin D deficiency treatment group, vitamin D insufficiency treatment group |
Primary outcome
volume of the total fibroids
Time frame: two years after treatment
percent change in volume of the largest fibroid compared to baseline in different groups
8 secondary outcomes
percentage of subjects undergoing other medical or surgical treatment of uterine fibroids
Time frame: two years after treatment
Hypercalcemia
Time frame: Two years after treatment
abnormal liver function
Time frame: Two years after treatment
urinary calculus
Time frame: Two years after treatment
abnormal renal function
Time frame: Two years after treatment
volume of the largest fibroid
Time frame: One year after treatment
volume of the total fibroids
Time frame: One year after treatment
volume of the largest fibroid
Time frame: two years after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Derived from this study: PubMed 33158822Sheng B, Song Y, Liu Y, Jiang C, Zhu X. Association between vitamin D and uterine fibroids: a study protocol of an open-label, randomised controlled trial. BMJ Open. 2020 Nov 6;10(11):e038709. doi: 10.1136/bmjopen-2020-038709.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D 3 in people with Gynaecological Disease and Vitamin D Deficiency, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
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 4 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xueqiong Zhu, PHD (13906640759, zjwzzxq@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
volume of the total fibroids (time frame: two years after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03584529, which also lists 1 linked publication.
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 5 Sep 2018.