Gynaecological Disease, Uterine Fibroids, Vitamin D Deficiency
Conditions
Brief summary
The aim of this randomised clinical trial study is to evaluate whether supplementation with vitamin D could reduce the risk of uterine fibroids in reproductive stage women.
Detailed description
A total of 1160 hypovitaminosis D patients (12 ng/ml ≤ serum 25-hydroxyvitamin D3 \< 20 ng/ml) without uterine fibroids will be randomly assigned in a ratio of 1:1 to two groups: intervention group and control group. The intervention group will receive 1600 IU/d of vitamin D3; the control group will receive regular follow-up. Patients will be followed up at the same time points for 24 months. The outcome measure is the incidence of uterine fibroids in different groups.
Interventions
DRUGVitamin D3 400 UNT Oral Capsule
50,000 IU of vitamin D once a week for 8 weeks, 1500-2000 IU/day.
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
Yes
Inclusion criteria
1. Volunteer to participate in the study with informed consent; 2. Females aged 35-50 who are confirmed with a normal, fibroid-free uterine structure, by means of transvaginal or abdominal ultrasonography; 3. Serum25-hydroxyvitamin D3 \<20 ng/ml, ≥ 12ng/ml.
Exclusion criteria
1. Use of sexual hormone, mifepristone, gonadotropin-releasing hormone agonist (GnRHa), or other medication which is likely to interfere with uterine fibroids within 3 months; 2. Pregnancy, lactation, postmenopause, or planned pregnancy within two years; 3. Allergic to vitamin D3; 4. Suspected or identified as other tumors of genital tract; 5. History of hysterectomy or myomectomy; 6. History of osteoporosis or vitamin D deficiency taking vitamin D supplements within previous one month; 7. History of hyperparathyroidism, infectious diseases (tuberculosis, AIDS), autoimmune diseases, or digestive system diseases (malabsorption, crohn disease and dysentery); 8. 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; 9. Creatinine levels ≥ 1.4 mg/dL (123μmol/L) or creatinine clearance ≤ 50 ml/min; 10. History of malignant tumors; 11. 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 |
|---|---|---|
| Incidence rate of uterine fibroids in different groups | two years after treatment | Incidence rate of uterine fibroids in different groups after two years treatment |
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, or total bilirubin (TBIL) more than 2 times of the normal upper limit |
| abnormal renal function | Two years after treatment | Creatinine levels≥1.4 mg/dL (123μmol/L) or creatinine clearance ≤ 50 mL/min |
| Incidence rate of uterine fibroids in different groups | One year after treatment | Incidence rate of uterine fibroids in different groups after one year treatment |
Countries
China
Contacts
Primary ContactXueqiong Zhu, PHD
Outcome results
None listed