Clinical trial NCT03584529: Association Between Vitamin D and the Development of Uterine Fibroids
Official title: Association Between Vitamin D and the Development of Uterine Fibroids
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gynaecological Disease
Vitamin D Deficiency
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2018-07-12
Enrollment: 360
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;
* 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.

Primary outcomes:
measure: volume of the total fibroids
timeFrame: two years after treatment
Secondary outcomes:
measure: percentage of subjects undergoing other medical or surgical treatment of uterine fibroids
timeFrame: two years after treatment
measure: Hypercalcemia
timeFrame: Two years after treatment
measure: abnormal liver function
timeFrame: Two years after treatment
measure: urinary calculus
timeFrame: Two years after treatment
measure: abnormal renal function
timeFrame: Two years after treatment
measure: volume of the largest fibroid
timeFrame: One year after treatment
measure: volume of the total fibroids
timeFrame: One year after treatment
measure: volume of the largest fibroid
timeFrame: two years after treatment
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
References:
citation: 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.