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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
360
Non-Vitamin D3 Drops group Patients in this group would take nothing.
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
volume of the total fibroids
percent change in volume of the largest fibroid compared to baseline in different groups
Time frame: two years after treatment
percentage of subjects undergoing other medical or surgical treatment of uterine fibroids
percentage of subjects undergoing other medical or surgical treatment of uterine fibroids
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, total bilirubin (TBIL) more than 2 times of the normal upper limit
Time frame: Two years after treatment
urinary calculus
urinary calculus
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
volume of the largest fibroid
percent change in volume of the largest fibroid compared to baseline in different groups
Time frame: One year after treatment
volume of the total fibroids
percent change in volume of the total fibroids compared to baseline in different groups
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Time frame: One year after treatment
volume of the largest fibroid
percent change in volume of the largest fibroid compared to baseline in different groups
Time frame: two years after treatment