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Association Between Vitamin D and the Development of Uterine Fibroids

Primary Purpose

Gynaecological Disease, Vitamin D Deficiency

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Vitamin D 3

About this trial

This is an interventional treatment trial for Gynaecological Disease

Eligibility Criteria

35 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

1. Patients are willing to cooperate with the follow-up and sign informed consent;
2. Females aged 35-50 who are diagnosed as having uterine fibroids by transvaginal or abdominal ultrasonography;
3. The maximum average diameter of intramural myoma is ≤ 4cm，≥ 1cm; The amount of myoma is less than 4;
4. Serum 25-hydroxyvitamin D3 < 30 ng/ml, ≥ 12 ng/ml.

Exclusion Criteria:

1. Patients with heavy menstrual bleeding (>80.0 mL), menstrual disorders, pelvic discomfort, infertility, or other indications for operation;
2. Patients complicated with myoma degeneration and adenomyosis that were suspected or diagnosed by ultrasound or gynecologic examination;
3. Allergic to vitamin D3;
4. Use of sexual hormone, mifepristone, gonadotropin-releasing hormone agonist (GnRHa), or other medication which is likely to interfere with uterine fibroids within 3 months;
5. Pregnancy, lactation, postmenopause, or planned pregnancy within two years;
6. Suspected or identified as other tumors of genital tract;
7. History of osteoporosis or vitamin D deficiency taking vitamin D supplements within previous one month;
8. History of autoimmune diseases, infectious diseases (tuberculosis, AIDS), autoimmune diseases, digestive system diseases (malabsorption, crohn disease, and dysentery);
9. 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;
10. Creatinine levels≥1.4 mg/dL (123μmol/L) or creatinine clearance ≤ 50 mL/min;
11. History of malignant tumors;
12. 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 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

vitamin D deficiency treatment group

vitamin D deficiency control group

vitamin D insufficiency treatment group

vitamin D insufficiency control group

Arm Description

patients with vitamin D deficiency (12 ng/ml ≤ serum 25-hydroxyvitamin D3 < 20 ng/ml)and uterine fibroids receive 1600 IU/day of vitamin D3 oral capsule for two years

patients with vitamin D deficiency (12 ng/ml ≤ serum 25-hydroxyvitamin D3 < 20 ng/ml)and uterine fibroids receive regular follow-up.

patients with vitamin D insufficiency (20 ng/ml ≤ serum 25-hydroxyvitamin D3 < 30 ng/ml) and uterine fibroids receive 800 IU/d of vitamin D3

patients with vitamin D insufficiency (20 ng/ml ≤ serum 25-hydroxyvitamin D3 < 30 ng/ml)and uterine fibroids receive regular follow-up.

Outcomes

Primary Outcome Measures

volume of the total fibroids

percent change in volume of the largest fibroid compared to baseline in different groups

Secondary Outcome Measures

percentage of subjects undergoing other medical or surgical treatment of uterine fibroids

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, total bilirubin (TBIL) more than 2 times of the normal upper limit

urinary calculus

abnormal renal function

Creatinine levels ≧ 1.4 mg/dL (123μmol/L) or creatinine clearance ≦ 50 mL/min

volume of the largest fibroid

percent change in volume of the largest fibroid compared to baseline in different groups

volume of the total fibroids

percent change in volume of the total fibroids compared to baseline in different groups

volume of the largest fibroid

percent change in volume of the largest fibroid compared to baseline in different groups

Full Information

NCT ID

NCT03584529

First Posted

June 13, 2018

Last Updated

September 2, 2018

Sponsor

Second Affiliated Hospital of Wenzhou Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03584529

Brief Title

Association Between Vitamin D and the Development of Uterine Fibroids

Official Title

Association Between Vitamin D and the Development 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

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

the aim of this randomised clinical trial study is to evaluate whether supplementation with vitamin D could inhibit the growth of uterine fibroids in reproductive stage women.

Detailed Description

180 patients with vitamin D deficiency (12 ng/ml ≤ serum 25-hydroxyvitamin D3 < 20 ng/ml) and uterine fibroids will be randomly assigned in a ratio of 1:1 to two groups: intervention group A and control group B. 180 patients with vitamin D insufficiency (20 ng/ml ≤ serum 25-hydroxyvitamin D3 < 30 ng/ml) and uterine fibroids will be also randomly assigned in a ratio of 1:1 to two groups: intervention group C and control group D. The intervention group A will receive 1600 IU/d of vitamin D3; The intervention group C will receive 800 IU/d of vitamin D3; the control group B and the control group D will receive regular follow-up. Patients will be followed up at the same time points for 24 months. The outcome measure is the growth 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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

vitamin D deficiency treatment group

Arm Type

Experimental

Arm Description

patients with vitamin D deficiency (12 ng/ml ≤ serum 25-hydroxyvitamin D3 < 20 ng/ml)and uterine fibroids receive 1600 IU/day of vitamin D3 oral capsule for two years

Arm Title

vitamin D deficiency control group

Arm Type

No Intervention

Arm Description

patients with vitamin D deficiency (12 ng/ml ≤ serum 25-hydroxyvitamin D3 < 20 ng/ml)and uterine fibroids receive regular follow-up.

Arm Title

vitamin D insufficiency treatment group

Arm Type

Experimental

Arm Description

patients with vitamin D insufficiency (20 ng/ml ≤ serum 25-hydroxyvitamin D3 < 30 ng/ml) and uterine fibroids receive 800 IU/d of vitamin D3

Arm Title

vitamin D insufficiency control group

Arm Type

No Intervention

Arm Description

patients with vitamin D insufficiency (20 ng/ml ≤ serum 25-hydroxyvitamin D3 < 30 ng/ml)and uterine fibroids receive regular follow-up.

Intervention Type

Drug

Intervention Name(s)

Vitamin D 3

Intervention Description

Non-Vitamin D3 Drops group Patients in this group would take nothing.

Primary Outcome Measure Information:

Title

volume of the total fibroids

Description

percent change in volume of the largest fibroid compared to baseline in different groups

Time Frame

two years after treatment

Secondary Outcome Measure Information:

Title

percentage of subjects undergoing other medical or surgical treatment of uterine fibroids

Description

percentage of subjects undergoing other medical or surgical treatment of uterine fibroids

Time Frame

two years after treatment

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, total bilirubin (TBIL) more than 2 times of the normal upper limit

Time Frame

Two years after treatment

Title

urinary calculus

Description

urinary calculus

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

volume of the largest fibroid

Description

percent change in volume of the largest fibroid compared to baseline in different groups

Time Frame

One year after treatment

Title

volume of the total fibroids

Description

percent change in volume of the total fibroids compared to baseline in different groups

Time Frame

One year after treatment

Title

volume of the largest fibroid

Description

percent change in volume of the largest fibroid compared to baseline in different groups

Time Frame

two years after treatment

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 1. Patients are willing to cooperate with the follow-up and sign informed consent; 2. Females aged 35-50 who are diagnosed as having uterine fibroids by transvaginal or abdominal ultrasonography; 3. The maximum average diameter of intramural myoma is ≤ 4cm，≥ 1cm; The amount of myoma is less than 4; 4. Serum 25-hydroxyvitamin D3 < 30 ng/ml, ≥ 12 ng/ml. Exclusion Criteria: 1. Patients with heavy menstrual bleeding (>80.0 mL), menstrual disorders, pelvic discomfort, infertility, or other indications for operation; 2. Patients complicated with myoma degeneration and adenomyosis that were suspected or diagnosed by ultrasound or gynecologic examination; 3. Allergic to vitamin D3; 4. Use of sexual hormone, mifepristone, gonadotropin-releasing hormone agonist (GnRHa), or other medication which is likely to interfere with uterine fibroids within 3 months; 5. Pregnancy, lactation, postmenopause, or planned pregnancy within two years; 6. Suspected or identified as other tumors of genital tract; 7. History of osteoporosis or vitamin D deficiency taking vitamin D supplements within previous one month; 8. History of autoimmune diseases, infectious diseases (tuberculosis, AIDS), autoimmune diseases, digestive system diseases (malabsorption, crohn disease, and dysentery); 9. 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; 10. Creatinine levels≥1.4 mg/dL (123μmol/L) or creatinine clearance ≤ 50 mL/min; 11. History of malignant tumors; 12. 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

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

feclinicalresearch@163.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

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 Development of Uterine Fibroids

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