Association Between Vitamin D and the Risk of Uterine Fibroids

Study Overview
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Brief Summary
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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
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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.

Official Title
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Association Between Vitamin D and the Risk of Uterine Fibroids

Conditions
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Gynaecological Disease, Vitamin D Deficiency, Uterine Fibroids

Intervention / Treatment
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* Drug: Vitamin D3 400 UNT Oral Capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Volunteer to participate in the study with informed consent; Females aged 35-50 who are confirmed with a normal, fibroid-free uterine structure, by means of transvaginal or abdominal ultrasonography; Serum25-hydroxyvitamin D3 <20 ng/ml, ≥ 12ng/ml. Exclusion Criteria: Use of sexual hormone, mifepristone, gonadotropin-releasing hormone agonist (GnRHa), or other medication which is likely to interfere with uterine fibroids within 3 months; Pregnancy, lactation, postmenopause, or planned pregnancy within two years; Allergic to vitamin D3; Suspected or identified as other tumors of genital tract; History of hysterectomy or myomectomy; History of osteoporosis or vitamin D deficiency taking vitamin D supplements within previous one month; History of hyperparathyroidism, infectious diseases (tuberculosis, AIDS), autoimmune diseases, or digestive system diseases (malabsorption, crohn disease and dysentery); 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; Creatinine levels ≥ 1.4 mg/dL (123μmol/L) or creatinine clearance ≤ 50 ml/min; History of malignant tumors; Simultaneous participation in another clinical study with investigational medicinal product(s) or researcher thinks the subjects are not suitable for this trial.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D3 Drops group<br>Patients in this group would take Vitamin D3 400 UNT Oral Capsule. | Drug: Vitamin D3 400 UNT Oral Capsule<br>* 50,000 IU of vitamin D once a week for 8 weeks, 1500-2000 IU/day.<br>* Other names: Vitamin D3 drops;|
| No Intervention: Non-Vitamin D3 Drops group<br>Patients in this group would take nothing. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of uterine fibroids in different groups | Incidence rate of uterine fibroids in different groups after two years treatment | two years after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypercalcemia | The level of serum calcium > 2.5 mmol/L | 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 | Two years after treatment | 
| abnormal renal function | Creatinine levels≥1.4 mg/dL (123μmol/L) or creatinine clearance ≤ 50 mL/min | Two years after treatment | 
| Incidence rate of uterine fibroids in different groups | Incidence rate of uterine fibroids in different groups after one year treatment | One year after treatment |