Association Between Vitamin D and the Risk of Uterine Fibroids (ABVDATROUF)

September 3, 2018 updated by: Second Affiliated Hospital of Wenzhou Medical University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

1160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin D3 Drops group
Patients in this group would take Vitamin D3 400 UNT Oral Capsule.
Drug: Vitamin D3 400 UNT Oral Capsule
50,000 IU of vitamin D once a week for 8 weeks, 1500-2000 IU/day.
Other Names:
  • Vitamin D3 drops
No Intervention: Non-Vitamin D3 Drops group
Patients in this group would take nothing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence rate of uterine fibroids in different groups
Time Frame: two years after treatment
Incidence rate of uterine fibroids in different groups after two years treatment
two years after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypercalcemia
Time Frame: Two years after treatment
The level of serum calcium > 2.5 mmol/L
Two years after treatment
abnormal liver function
Time Frame: Two years after treatment
Alanine aminotransferase (ALT) or aspartate transaminase (AST) more than 3 times of the normal upper limit, or total bilirubin (TBIL) more than 2 times of the normal upper limit
Two years after treatment
abnormal renal function
Time Frame: Two years after treatment
Creatinine levels≥1.4 mg/dL (123μmol/L) or creatinine clearance ≤ 50 mL/min
Two years after treatment
Incidence rate of uterine fibroids in different groups
Time Frame: One year after treatment
Incidence rate of uterine fibroids in different groups after one year treatment
One year after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Wenzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 15, 2018

Primary Completion (Anticipated)

January 1, 2021

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

June 12, 2018

First Submitted That Met QC Criteria

July 12, 2018

First Posted (Actual)

July 16, 2018

Study Record Updates

Last Update Posted (Actual)

September 5, 2018

Last Update Submitted That Met QC Criteria

September 3, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAHoWMU-CR2017-07-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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