Clinical trial · Observational
Vitamin D Deficit in Women With Uterine Fibroids
NCT04030182CI-TRIAL-00054921completedClinicalTrials.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)
Determinate the level of vitamin D in blood, and evaluate the prevalence of deficit and insufficiency among patients with diagnosis of uterine fibroids
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 |
|---|---|---|---|
| Fibroid Uterus | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
| Leiomyoma | Leiomyoma | ONTOLOGY_EXACT | 0.98 |
| Vitamin D Deficiency | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Level of Vitamin D | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Level of vitamin D
- description
- Level in blood sample of vitamin D for each patient
- interventionNames
- Diagnostic Test: Level of Vitamin D
Primary outcomes (1)
- measure
- appointment for intervention
- timeFrame
- 15 minutes
- description
- All patients diagnosed with uterine fibroids who come for consultation, will be explained the protocol and if they agree to be part of it, an informed consent will be given and a 3 ml sample of venous blood will be taken. The sample will be analize in a COBAS 6000 ANALYZER SERIES model c501 (by ROCHE) and the reference levels will be: 1-25 ng/mL - DEFICIT 25 - 30 ng/mL - INSUFFICIENCY \> 30 ng/mL - Normal For this study, the qualitative variables will be expressed as frequencies and percentages (%); the quantitative variables will be expressed in means ± standard deviation. The prevalence of vitamin D deficiency at baseline will be calculated using the formula (total cases observed with vitamin D deficiency / total of patients included) X 100.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Female * Diagnosis of uterine fibroid Exclusion Criteria: * Female with diagnosis of uterine fibroid under treatment with exogenous vitamine D
References
Publications (17)
- BACKGROUNDBlauer M, Rovio PH, Ylikomi T, Heinonen PK. Vitamin D inhibits myometrial and leiomyoma cell proliferation in vitro. Fertil Steril. 2009 May;91(5):1919-25. doi: 10.1016/j.fertnstert.2008.02.136. Epub 2008 Apr 18. PMID 18423458
- BACKGROUNDPavone D, Clemenza S, Sorbi F, Fambrini M, Petraglia F. Epidemiology and Risk Factors of Uterine Fibroids. Best Pract Res Clin Obstet Gynaecol. 2018 Jan;46:3-11. doi: 10.1016/j.bpobgyn.2017.09.004. Epub 2017 Oct 1. PMID 29054502
- BACKGROUNDLukes AS, Soper D, Harrington A, Sniukiene V, Mo Y, Gillard P, Shulman L. Health-Related Quality of Life With Ulipristal Acetate for Treatment of Uterine Leiomyomas: A Randomized Controlled Trial. Obstet Gynecol. 2019 May;133(5):869-878. doi: 10.1097/AOG.0000000000003211. PMID 30969201
- RESULTHolick MF, Binkley NC, Bischoff-Ferrari HA, Gordon CM, Hanley DA, Heaney RP, Murad MH, Weaver CM; Endocrine Society. Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011 Jul;96(7):1911-30. doi: 10.1210/jc.2011-0385. Epub 2011 Jun 6. PMID 21646368
- RESULTCashman KD, Sheehy T, O'Neill CM. Is vitamin D deficiency a public health concern for low middle income countries? A systematic literature review. Eur J Nutr. 2019 Feb;58(1):433-453. doi: 10.1007/s00394-018-1607-3. Epub 2018 Jan 17. PMID 29344677
- RESULTAtkinson SA. [The new dietary reference intakes from the Institute of Medicine for calcium and vitamin D]. Perspect Infirm. 2011 Sep-Oct;8(5):5. No abstract available. French. PMID 21939083
- RESULTHalder S, Al-Hendy A. Hypovitaminosis D and high serum transforming growth factor beta-3: important biomarkers for uterine fibroids risk. Fertil Steril. 2016 Dec;106(7):1648-1649. doi: 10.1016/j.fertnstert.2016.09.048. Epub 2016 Oct 25. No abstract available.