Association Between Vitamin D and the Development of Uterine Fibroids

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-15

Study Completion Date

2021-07-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gynaecological Disease Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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vitamin D deficiency treatment group

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

Group Type EXPERIMENTAL

Vitamin D 3

Intervention Type DRUG

Non-Vitamin D3 Drops group Patients in this group would take nothing.

vitamin D deficiency control group

patients with vitamin D deficiency (12 ng/ml ≤ serum 25-hydroxyvitamin D3 \< 20 ng/ml)and uterine fibroids receive regular follow-up.

Group Type NO_INTERVENTION

No interventions assigned to this group

vitamin D insufficiency treatment group

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

Group Type EXPERIMENTAL

Vitamin D 3

Intervention Type DRUG

Non-Vitamin D3 Drops group Patients in this group would take nothing.

vitamin D insufficiency control group

patients with vitamin D insufficiency (20 ng/ml ≤ serum 25-hydroxyvitamin D3 \< 30 ng/ml)and uterine fibroids receive regular follow-up.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vitamin D 3

Non-Vitamin D3 Drops group Patients in this group would take nothing.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No