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Association Between Vitamin D and the Development of Uterine Fibroids

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ClinicalTrials.gov Identifier: NCT03584529
Recruitment Status : Not yet recruiting
First Posted : July 12, 2018
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital of Wenzhou Medical University

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.

Condition or disease Intervention/treatment Phase
Gynaecological Disease Vitamin D Deficiency Drug: Vitamin D 3 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Association Between Vitamin D and the Development of Uterine Fibroids
Estimated Study Start Date : September 15, 2018
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: vitamin D deficiency treatment group
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
Non-Vitamin D3 Drops group Patients in this group would take nothing.

No Intervention: vitamin D deficiency control group
patients with vitamin D deficiency (12 ng/ml ≤ serum 25-hydroxyvitamin D3 < 20 ng/ml)and uterine fibroids receive regular follow-up.
Experimental: vitamin D insufficiency treatment group
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
Non-Vitamin D3 Drops group Patients in this group would take nothing.

No Intervention: vitamin D insufficiency control group
patients with vitamin D insufficiency (20 ng/ml ≤ serum 25-hydroxyvitamin D3 < 30 ng/ml)and uterine fibroids receive regular follow-up.



Primary Outcome Measures :
  1. volume of the total fibroids [ Time Frame: two years after treatment ]
    percent change in volume of the largest fibroid compared to baseline in different groups


Secondary Outcome Measures :
  1. percentage of subjects undergoing other medical or surgical treatment of uterine fibroids [ Time Frame: two years after treatment ]
    percentage of subjects undergoing other medical or surgical treatment of uterine fibroids

  2. Hypercalcemia [ Time Frame: Two years after treatment ]
    The level of serum calcium > 2.5 mmol/L

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

  4. urinary calculus [ Time Frame: Two years after treatment ]
    urinary calculus

  5. abnormal renal function [ Time Frame: Two years after treatment ]
    Creatinine levels ≧ 1.4 mg/dL (123μmol/L) or creatinine clearance ≦ 50 mL/min

  6. volume of the largest fibroid [ Time Frame: One year after treatment ]
    percent change in volume of the largest fibroid compared to baseline in different groups

  7. volume of the total fibroids [ Time Frame: One year after treatment ]
    percent change in volume of the total fibroids compared to baseline in different groups

  8. volume of the largest fibroid [ Time Frame: two years after treatment ]
    percent change in volume of the largest fibroid compared to baseline in different groups



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Ages Eligible for Study:   35 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584529


Contacts
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Contact: Xueqiong Zhu, PHD 13906640759 zjwzzxq@163.com

Locations
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China, Zhejiang
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University Not yet recruiting
Wenzhou, Zhejiang, China, 325000
Contact: TING LI       feclinicalresearch@163.com   
Sponsors and Collaborators
Second Affiliated Hospital of Wenzhou Medical University
  Study Documents (Full-Text)

Documents provided by Second Affiliated Hospital of Wenzhou Medical University:

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Responsible Party: Second Affiliated Hospital of Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT03584529     History of Changes
Other Study ID Numbers: SAHoWMU-CR2017-07-126
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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

Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Genital Diseases, Female
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents