Association Between Vitamin D and the Development of Uterine Fibroids

NCT03584529 | Unknown

• 1 other identifier: SAHoWMU-CR2017-07-126
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynaecological Disease; Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

• volume of the total fibroids

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

  two years after treatment

Secondary Outcomes (8)

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

  two years after treatment

• Hypercalcemia

  Two years after treatment

• abnormal liver function

  Two years after treatment

• urinary calculus

  Two years after treatment

• abnormal renal function

  Two years after treatment

Study Arms (4)

vitamin D deficiency treatment group

EXPERIMENTAL

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

Drug: Vitamin D 3

vitamin D deficiency control group

NO INTERVENTION

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

vitamin D insufficiency treatment group

EXPERIMENTAL

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

Drug: Vitamin D 3

vitamin D insufficiency control group

NO INTERVENTION

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

Interventions

Vitamin D 3 DRUG

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

vitamin D deficiency treatment group; vitamin D insufficiency treatment group

Eligibility Criteria

• Age: 35 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \. Patients with heavy menstrual bleeding (\>80.0 mL), menstrual disorders, pelvic discomfort, infertility, or other indications for operation;
• \. Patients complicated with myoma degeneration and adenomyosis that were suspected or diagnosed by ultrasound or gynecologic examination;
• \. Allergic to vitamin D3;
• \. 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;
• \. Suspected or identified as other tumors of genital tract;
• \. History of osteoporosis or vitamin D deficiency taking vitamin D supplements within previous one month;
• \. History of autoimmune diseases, infectious diseases (tuberculosis, AIDS), autoimmune diseases, 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

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: 33158822 DERIVED

MeSH Terms

Conditions

Genital Diseases, Female; Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Central Study Contacts

Xueqiong Zhu, PHD

CONTACT

13906640759; zjwzzxq@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 13, 2018
• First Posted: July 12, 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

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)