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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,160
50,000 IU of vitamin D once a week for 8 weeks, 1500-2000 IU/day.
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Incidence rate of uterine fibroids in different groups
Incidence rate of uterine fibroids in different groups after two years treatment
Time frame: two years after treatment
Hypercalcemia
The level of serum calcium \> 2.5 mmol/L
Time frame: Two years after treatment
abnormal liver function
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
Time frame: Two years after treatment
abnormal renal function
Creatinine levels≥1.4 mg/dL (123μmol/L) or creatinine clearance ≤ 50 mL/min
Time frame: Two years after treatment
Incidence rate of uterine fibroids in different groups
Incidence rate of uterine fibroids in different groups after one year treatment
Time frame: One year after treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.