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Status unknownNCT03584529Updated Sep 5, 2018

Association Between Vitamin D and the Development of Uterine Fibroids

An interventional study of Vitamin D 3 in Gynaecological Disease and Vitamin D Deficiency, sponsored by Second Affiliated Hospital of Wenzhou Medical University. Status unknown at 1 site in China. Open to female participants aged 35 Years to 50 Years. Per ClinicalTrials.gov, last updated 2018-09-05.

Sponsored by Second Affiliated Hospital of Wenzhou Medical University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
360
Allocation
Randomized
Ages
35 Years to 50 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Gynaecological Disease
  • Vitamin D Deficiency
03

In context

Leiomyoma

490 studies on the registry are indexed under Leiomyoma; 81 are open to participants now.

This study's planned enrollment of 360 is above the median of 62 across 345 interventional studies indexed under Leiomyoma.

Browse Leiomyoma studies →

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University is the lead sponsor of 133 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

    1. Patients are willing to cooperate with the follow-up and sign informed consent;
    1. Females aged 35-50 who are diagnosed as having uterine fibroids by transvaginal or abdominal ultrasonography;
    1. The maximum average diameter of intramural myoma is ≤ 4cm，≥ 1cm; The amount of myoma is less than 4;
    1. Serum 25-hydroxyvitamin D3 \< 30 ng/ml, ≥ 12 ng/ml.

Exclusion criteria

Exclusion Criteria:

    1. Patients with heavy menstrual bleeding (>80.0 mL), menstrual disorders, pelvic discomfort, infertility, or other indications for operation;
    1. Patients complicated with myoma degeneration and adenomyosis that were suspected or diagnosed by ultrasound or gynecologic examination;
    1. Allergic to vitamin D3;
    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;
    1. Pregnancy, lactation, postmenopause, or planned pregnancy within two years;
    1. Suspected or identified as other tumors of genital tract;
    1. History of osteoporosis or vitamin D deficiency taking vitamin D supplements within previous one month;
    1. History of autoimmune diseases, infectious diseases (tuberculosis, AIDS), autoimmune diseases, digestive system diseases (malabsorption, crohn disease, and dysentery);
    1. 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;
    1. Creatinine levels≥1.4 mg/dL (123μmol/L) or creatinine clearance ≤ 50 mL/min;
    1. History of malignant tumors;
    1. Simultaneous participation in another clinical study with investigational medicinal product(s) or researcher thinks the subjects are not suitable for this trial.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
360 participants (estimated)

Study arms

  • Experimental
    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

    Drug: Vitamin D 3

  • No intervention
    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.

  • Experimental
    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

    Drug: Vitamin D 3

  • No intervention
    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.

Interventions

  • DrugVitamin D 3

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

06

What researchers measure

Primary outcomes

  1. volume of the total fibroids

    percent change in volume of the largest fibroid compared to baseline in different groups

    Time frame: two years after treatment

Secondary outcomes

  1. percentage of subjects undergoing other medical or surgical treatment of uterine fibroids

    percentage of subjects undergoing other medical or surgical treatment of uterine fibroids

    Time frame: two years after treatment

  2. Hypercalcemia

    The level of serum calcium \> 2.5 mmol/L

    Time frame: Two years after treatment

  3. 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

    Time frame: Two years after treatment

  4. urinary calculus

    urinary calculus

    Time frame: Two years after treatment

  5. abnormal renal function

    Creatinine levels ≧ 1.4 mg/dL (123μmol/L) or creatinine clearance ≦ 50 mL/min

    Time frame: Two years after treatment

  6. volume of the largest fibroid

    percent change in volume of the largest fibroid compared to baseline in different groups

    Time frame: One year after treatment

  7. volume of the total fibroids

    percent change in volume of the total fibroids compared to baseline in different groups

    Time frame: One year after treatment

  8. volume of the largest fibroid

    percent change in volume of the largest fibroid compared to baseline in different groups

    Time frame: two years after treatment

07

Study locations

1 site
  • The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
    Wenzhou, Zhejiang 325000, China
08

References and documents

Publications

  • Sheng B, Song Y, Liu Y, Jiang C, Zhu X. Association between vitamin D and uterine fibroids: a study protocol of an open-label, randomised controlled trial. BMJ Open. 2020 Nov 6;10(11):e038709. doi: 10.1136/bmjopen-2020-038709. PubMed 33158822 ↗

Study documents

  • Protocol and statistical analysis plan · Mar 15, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03584529
Lead sponsor
Second Affiliated Hospital of Wenzhou Medical University
Responsible party
Sponsor
First posted
Jul 12, 2018
Start date
Sep 15, 2018 (estimated)
Primary completion
Jan 1, 2021 (estimated)
Completion
Jul 1, 2021 (estimated)
Last update
Sep 5, 2018

Study contacts

Xueqiong Zhu, PHD
Contact
zjwzzxq@163.com
13906640759

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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