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

Primary Purpose

Gynaecological Disease, Vitamin D Deficiency, Uterine Fibroids

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Vitamin D3 400 UNT Oral Capsule
Sponsored by
Second Affiliated Hospital of Wenzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gynaecological Disease

Eligibility Criteria

35 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Vitamin D3 Drops group

Non-Vitamin D3 Drops group

Arm Description

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

Patients in this group would take nothing.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Hypercalcemia
The level of serum calcium > 2.5 mmol/L
abnormal liver function
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
abnormal renal function
Creatinine levels≥1.4 mg/dL (123μmol/L) or creatinine clearance ≤ 50 mL/min
Incidence rate of uterine fibroids in different groups
Incidence rate of uterine fibroids in different groups after one year treatment

Full Information

First Posted
June 12, 2018
Last Updated
September 3, 2018
Sponsor
Second Affiliated Hospital of Wenzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03586947
Brief Title
Association Between Vitamin D and the Risk of Uterine Fibroids
Acronym
ABVDATROUF
Official Title
Association Between Vitamin D and the Risk of Uterine Fibroids
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2018 (Anticipated)
Primary Completion Date
January 1, 2021 (Anticipated)
Study Completion Date
July 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital of Wenzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynaecological Disease, Vitamin D Deficiency, Uterine Fibroids

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D3 Drops group
Arm Type
Experimental
Arm Description
Patients in this group would take Vitamin D3 400 UNT Oral Capsule.
Arm Title
Non-Vitamin D3 Drops group
Arm Type
No Intervention
Arm Description
Patients in this group would take nothing.
Intervention Type
Drug
Intervention Name(s)
Vitamin D3 400 UNT Oral Capsule
Other Intervention Name(s)
Vitamin D3 drops
Intervention Description
50,000 IU of vitamin D once a week for 8 weeks, 1500-2000 IU/day.
Primary Outcome Measure Information:
Title
Incidence rate of uterine fibroids in different groups
Description
Incidence rate of uterine fibroids in different groups after two years treatment
Time Frame
two years after treatment
Secondary Outcome Measure Information:
Title
Hypercalcemia
Description
The level of serum calcium > 2.5 mmol/L
Time Frame
Two years after treatment
Title
abnormal liver function
Description
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
Time Frame
Two years after treatment
Title
abnormal renal function
Description
Creatinine levels≥1.4 mg/dL (123μmol/L) or creatinine clearance ≤ 50 mL/min
Time Frame
Two years after treatment
Title
Incidence rate of uterine fibroids in different groups
Description
Incidence rate of uterine fibroids in different groups after one year treatment
Time Frame
One year after treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xueqiong Zhu, PHD
Phone
13906640759
Email
zjwzzxq@163.com
Facility Information:
Facility Name
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
TING LI
Email
feclinicalresearch@163.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
33158822
Citation
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.
Results Reference
derived

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Association Between Vitamin D and the Risk of Uterine Fibroids

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