Gynaecological Disease, Vitamin D Deficiency
Conditions
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.
Interventions
DRUGVitamin D 3
Non-Vitamin D3 Drops group Patients in this group would take nothing.
Sponsors
Second Affiliated Hospital of Wenzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| volume of the total fibroids | two years after treatment | percent change in volume of the largest fibroid compared to baseline in different groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypercalcemia | Two years after treatment | The level of serum calcium \> 2.5 mmol/L |
| abnormal liver function | Two years after treatment | 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 |
| urinary calculus | Two years after treatment | urinary calculus |
| percentage of subjects undergoing other medical or surgical treatment of uterine fibroids | two years after treatment | percentage of subjects undergoing other medical or surgical treatment of uterine fibroids |
| volume of the largest fibroid | One year after treatment | percent change in volume of the largest fibroid compared to baseline in different groups |
| volume of the total fibroids | One year after treatment | percent change in volume of the total fibroids compared to baseline in different groups |
| abnormal renal function | Two years after treatment | Creatinine levels ≧ 1.4 mg/dL (123μmol/L) or creatinine clearance ≦ 50 mL/min |
Countries
China
Contacts
Primary ContactXueqiong Zhu, PHD
Outcome results
None listed