Clinical trial · Interventional
Association Between Vitamin D and the Risk of Uterine Fibroids
NCT03586947CI-TRIAL-00034697ABVDATROUFunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynaecological Disease | — | UNRESOLVED | — |
| Uterine Fibroids | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
| Vitamin D Deficiency | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vitamin D3 400 UNT Oral Capsule | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Vitamin D3 Drops group
- description
- Patients in this group would take Vitamin D3 400 UNT Oral Capsule.
- interventionNames
- Drug: Vitamin D3 400 UNT Oral Capsule
- type
- NO_INTERVENTION
- label
- Non-Vitamin D3 Drops group
- description
- Patients in this group would take nothing.
Primary outcomes (1)
- measure
- Incidence rate of uterine fibroids in different groups
- timeFrame
- two years after treatment
- description
- Incidence rate of uterine fibroids in different groups after two years treatment
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDSheng 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