Association Between Vitamin D and the Risk 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

1160 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 reduce the risk of uterine fibroids in reproductive stage women.

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Detailed Description

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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.

Conditions

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Gynaecological Disease Vitamin D Deficiency Uterine Fibroids

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 D3 Drops group

Patients in this group would take Vitamin D3 400 UNT Oral Capsule.

Group Type EXPERIMENTAL

Vitamin D3 400 UNT Oral Capsule

Intervention Type DRUG

50,000 IU of vitamin D once a week for 8 weeks, 1500-2000 IU/day.

Non-Vitamin D3 Drops group

Patients in this group would take nothing.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vitamin D3 400 UNT Oral Capsule

50,000 IU of vitamin D once a week for 8 weeks, 1500-2000 IU/day.

Intervention Type DRUG

Other Intervention Names

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Vitamin D3 drops

Eligibility Criteria

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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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes