Association Between Vitamin D and the Development of Uterine Fibroids

Vitamin D Deficiency Clinical Trial

Official title:

Association Between Vitamin D and the Development of Uterine Fibroids

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03584529
• Other study ID #: SAHoWMU-CR2017-07-126
• 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 inhibit the growth of uterine fibroids in reproductive stage women.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. completion date: July 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 50 Years

Eligibility

Inclusion Criteria:

• 1. Patients are willing to cooperate with the follow-up and sign informed consent;

• 2. Females aged 35-50 who are diagnosed as having uterine fibroids by transvaginal or abdominal ultrasonography;

• 3. The maximum average diameter of intramural myoma is = 4cm,= 1cm; The amount of myoma is less than 4;

• 4. Serum 25-hydroxyvitamin D3 < 30 ng/ml, = 12 ng/ml.

Exclusion Criteria:

• 1. Patients with heavy menstrual bleeding (>80.0 mL), menstrual disorders, pelvic discomfort, infertility, or other indications for operation;

• 2. Patients complicated with myoma degeneration and adenomyosis that were suspected or diagnosed by ultrasound or gynecologic examination;

• 3. Allergic to vitamin D3;

• 4. Use of sexual hormone, mifepristone, gonadotropin-releasing hormone agonist (GnRHa), or other medication which is likely to interfere with uterine fibroids within 3 months;

• 5. Pregnancy, lactation, postmenopause, or planned pregnancy within two years;

• 6. Suspected or identified as other tumors of genital tract;

• 7. History of osteoporosis or vitamin D deficiency taking vitamin D supplements within previous one month;

• 8. History of autoimmune diseases, infectious diseases (tuberculosis, AIDS), autoimmune diseases, digestive system diseases (malabsorption, crohn disease, and dysentery);

• 9. 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;

• 10. Creatinine levels=1.4 mg/dL (123µmol/L) or creatinine clearance = 50 mL/min;

• 11. History of malignant tumors;

• 12. 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
• Vitamin D Deficiency

Intervention

Drug:
• Vitamin D 3
Non-Vitamin D3 Drops group Patients in this group would take nothing.

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	volume of the total fibroids	percent change in volume of the largest fibroid compared to baseline in different groups	two years after treatment
Secondary	percentage of subjects undergoing other medical or surgical treatment of uterine fibroids	percentage of subjects undergoing other medical or surgical treatment of uterine fibroids	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, total bilirubin (TBIL) more than 2 times of the normal upper limit	Two years after treatment
Secondary	urinary calculus	urinary calculus	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	volume of the largest fibroid	percent change in volume of the largest fibroid compared to baseline in different groups	One year after treatment
Secondary	volume of the total fibroids	percent change in volume of the total fibroids compared to baseline in different groups	One year after treatment
Secondary	volume of the largest fibroid	percent change in volume of the largest fibroid compared to baseline in different groups	two years after treatment