Association Between Vitamin D and the Risk of Uterine Fibroids

Vitamin D Deficiency Clinical Trial

— ABVDATROUF  

Official title:

Association Between Vitamin D and the Risk of Uterine Fibroids

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03586947
• Other study ID #: SAHoWMU-CR2017-07-101
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 15, 2018
• Est. completion date: July 1, 2021

Study information

• Verified date: July 2018
• Source: Second Affiliated Hospital of Wenzhou Medical University
• Contact: Xueqiong Zhu, PHD
• Phone: 13906640759
• Email: zjwzzxq[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1160
• Est. completion date: July 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Genital Diseases, Female
• Gynaecological Disease
• Leiomyoma
• Uterine Fibroids
• Vitamin D Deficiency

Intervention

Drug:
• Vitamin D3 400 UNT Oral Capsule
50,000 IU of vitamin D once a week for 8 weeks, 1500-2000 IU/day.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hypercalcemia	The level of serum calcium > 2.5 mmol/L	Two years after treatment
Secondary	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
Secondary	abnormal renal function	Creatinine levels=1.4 mg/dL (123µmol/L) or creatinine clearance = 50 mL/min	Two years after treatment
Secondary	Incidence rate of uterine fibroids in different groups	Incidence rate of uterine fibroids in different groups after one year treatment	One year after treatment