NCT03586947

Association Between Vitamin D and the Risk of Uterine Fibroids

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,160 (estimated)
• Sponsor: Second Affiliated Hospital of Wenzhou Medical University · Academic / Other
• Sex: Female
• Age: 35 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

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

• Gynaecological Disease
• Vitamin D Deficiency
• Uterine Fibroids

Interventions

Type	Name	Description
DRUG	Vitamin D3 400 UNT Oral Capsule	50,000 IU of vitamin D once a week for 8 weeks, 1500-2000 IU/day.

Timeline

• Start date: 2018-09-15
• Primary completion: 2021-01-01
• Completion: 2021-07-01
• First posted: 2018-07-16
• Last updated: 2018-09-05

Locations

1 site across 1 country: China