NCT03586947

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 16, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

September 15, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

September 5, 2018

Status Verified

July 1, 2018

Enrollment Period

2.3 years

First QC Date

June 12, 2018

Last Update Submit

September 3, 2018

Conditions

Gynaecological DiseaseVitamin D DeficiencyUterine Fibroids

Outcome Measures

Primary Outcomes (1)

  • Incidence rate of uterine fibroids in different groups

    Incidence rate of uterine fibroids in different groups after two years treatment

    two years after treatment

Secondary Outcomes (4)

  • Hypercalcemia

    Two years after treatment

  • abnormal liver function

    Two years after treatment

  • abnormal renal function

    Two years after treatment

  • Incidence rate of uterine fibroids in different groups

    One year after treatment

Study Arms (2)

Vitamin D3 Drops group

EXPERIMENTAL

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

Drug: Vitamin D3 400 UNT Oral Capsule

Non-Vitamin D3 Drops group

NO INTERVENTION

Patients in this group would take nothing.

Interventions

Vitamin D3 400 UNT Oral CapsuleDRUG

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

Also known as: Vitamin D3 drops
Vitamin D3 Drops group

Eligibility Criteria

Age35 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • Creatinine levels ≥ 1.4 mg/dL (123μmol/L) or creatinine clearance ≤ 50 ml/min;
  • History of malignant tumors;
  • Simultaneous participation in another clinical study with investigational medicinal product(s) or researcher thinks the subjects are not suitable for this trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

Related Publications (1)

  • 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.

    PMID: 33158822DERIVED

MeSH Terms

Conditions

Genital Diseases, FemaleVitamin D DeficiencyLeiomyoma

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesNeoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Central Study Contacts

Xueqiong Zhu, PHD

CONTACT

13906640759zjwzzxq@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2018

First Posted

July 16, 2018

Study Start

September 15, 2018

Primary Completion

January 1, 2021

Study Completion

July 1, 2021

Last Updated

September 5, 2018

Record last verified: 2018-07

Locations

CN(1)