Association Between Vitamin D and the Risk of Uterine Fibroids

Not Applicable

• Conditions: Gynaecological Disease; Vitamin D Deficiency; Uterine Fibroids
• Interventions: Drug: Vitamin D3 400 UNT Oral Capsule

• Registration Number: NCT03586947
• Lead Sponsor: Second Affiliated Hospital of Wenzhou Medical University

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.

Study Timeline

• Study First Submitted: 2018-06-12
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-12
• Study First Posted: 2018-07-16
• Last Update Submitted: 2018-09-03
• Last Update Posted: 2018-09-05
• Study Start: 2018-09-15
• Primary Completion: 2021-01-01
• Study Completion: 2021-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D3 Drops group	Vitamin D3 400 UNT Oral Capsule	Patients in this group would take Vitamin D3 400 UNT Oral Capsule.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
abnormal renal function	Two years after treatment	Creatinine levels≥1.4 mg/dL (123μmol/L) or creatinine clearance ≤ 50 mL/min
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
Incidence rate of uterine fibroids in different groups	One year after treatment	Incidence rate of uterine fibroids in different groups after one year treatment

Trial Locations

Locations (1)

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China