Association Between Vitamin D and the Development of Uterine Fibroids

Not Applicable

• Conditions: Vitamin D Deficiency; Gynaecological Disease
• Interventions: Drug: Vitamin D 3

• Registration Number: NCT03584529
• 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 inhibit the growth of uterine fibroids in reproductive stage women.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-06-13
• Study First Submitted QC: 2018-06-28
• Status Verified: 2018-07
• Study First Posted: 2018-07-12
• Last Update Submitted: 2018-09-02
• 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: 360

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vitamin D deficiency treatment group	Vitamin D 3	patients with vitamin D deficiency (12 ng/ml ≤ serum 25-hydroxyvitamin D3 \< 20 ng/ml)and uterine fibroids receive 1600 IU/day of vitamin D3 oral capsule for two years
vitamin D insufficiency treatment group	Vitamin D 3	patients with vitamin D insufficiency (20 ng/ml ≤ serum 25-hydroxyvitamin D3 \< 30 ng/ml) and uterine fibroids receive 800 IU/d of vitamin D3

Primary Outcome Measures

Name	Time	Method
volume of the total fibroids	two years after treatment	percent change in volume of the largest fibroid compared to baseline in different groups

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

Trial Locations

Locations (1)

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