UnknownNot Applicable

Association Between Vitamin D and the Risk of Uterine Fibroids

China1,160 participantsStarted 2018-09-15

Plain-language summary

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.

Who can participate

Age range35 Years – 50 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Volunteer to participate in the study with informed consent;
✓. Females aged 35-50 who are confirmed with a normal, fibroid-free uterine structure, by means of transvaginal or abdominal ultrasonography;
✓. Serum25-hydroxyvitamin D3 \<20 ng/ml, ≥ 12ng/ml.

Exclusion criteria

✕. Use of sexual hormone, mifepristone, gonadotropin-releasing hormone agonist (GnRHa), or other medication which is likely to interfere with uterine fibroids within 3 months;
✕. Pregnancy, lactation, postmenopause, or planned pregnancy within two years;
✕. Allergic to vitamin D3;
✕. Suspected or identified as other tumors of genital tract;
✕. History of hysterectomy or myomectomy;
✕. History of osteoporosis or vitamin D deficiency taking vitamin D supplements within previous one month;
✕. History of hyperparathyroidism, infectious diseases (tuberculosis, AIDS), autoimmune diseases, or digestive system diseases (malabsorption, crohn disease and dysentery);
✕. 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;

What they're measuring

Incidence rate of uterine fibroids in different groups

Timeframe: two years after treatment

Trial details

NCT IDNCT03586947

SponsorSecond Affiliated Hospital of Wenzhou Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-01-01

Contact for this trial

Xueqiong Zhu, PHD

13906640759 zjwzzxq@163.com

View on ClinicalTrials.gov More Gynaecological Disease trials