AzTrials
AzTrials

LeiomyomaNCT04030182

Vitamin D Deficit in Women With Uterine Fibroids

An observational study of Leiomyoma and Vitamin D Deficiency, run by Instituto Mexicano del Seguro Social at 2 sites in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Determinate the level of vitamin D in blood, and evaluate the prevalence of deficit and insufficiency among patients with diagnosis of uterine fibroids Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Leiomyoma, Vitamin D Deficiency, Fibroid Uterus
What is being tested?
Level of Vitamin D
How many people
127 participants
Where
2 sitesMexico
Study dates
1 Dec 2019to 9 Oct 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: All female patients diagnosed with uterine myomatosis who come for consultation, if they agree to be part of protocol, an informed consent will be given and a 3 ml sample of venous blood will be taken. The present study will be performed in two Hospitals: "Centro Médico Nacional de Occidente" (CMNO) "Hospital General Regional No. 45" (HGR 45) Both hospital established in the city of Guadalajara, Jalisco, Mexico.

Who may be able to join

  • Female
  • Diagnosis of uterine fibroid

Who cannot join

  • Female with diagnosis of uterine fibroid under treatment with exogenous vitamine D

Trial locations and contacts

2 sites in 1 country.

Mexico2 sites

  • Centro Médico Nacional de Occidente, Hospital de Gineco-Obstetricia

    Guadalajara, Jalisco, 44600

  • Hospital General Regional No. 45

    Guadalajara, Jalisco, 44600

Other trials in Mexico

About this study

Determinate the level of vitamin D in blood, and evaluate the prevalence of deficit and insufficiency among patients with diagnosis of uterine fibroids

Read the detailed description

A cross-sectional prevalence study will be carried out, taking patients with a diagnosis of uterine fibroid in two hospitals; blood level of vitamin D will be taken to determine the proportion of patients with deficit and insufficiency; In addition, the number, size and type (according to the PALM-COEN classification) of the uterine fibroids in each patient will be analyzed.

Being tested
Level of Vitamin D
Medical subject headings
Leiomyoma, Vitamin D Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Level of Vitamin DDiagnostic test

    3 ml of venous blood will be taken to determine the level of vitamin D

Study groups in NCT04030182
Study groupRoleWhat they receive
Level of vitamin DLevel in blood sample of vitamin D for each patient
Receives: Diagnostic Test: Level of Vitamin D

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. appointment for intervention

    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.

    Measured: 15 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2019
  2. Study start1 Dec 2019
  3. Primary completion9 Oct 2021
  4. Study completion9 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
127 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04030182
Sponsor's protocol ID
VIDANFI
Status last verified
Nov 2021
First submitted
2 Jul 2019
Last updated
8 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: because is an internal study in the hospital, and the committe doesn´s accept share any information

Publications

  • Blauer 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.

    PubMed 18423458

  • Pavone 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.

    PubMed 29054502

  • Lukes 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.

    PubMed 30969201

  • Holick 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.

    PubMed 21646368

  • Cashman 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.

    PubMed 29344677

  • Atkinson 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.

    PubMed 21939083

  • Halder 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.

    PubMed 27793369

  • Jukic AM, Steiner AZ, Baird DD. Lower plasma 25-hydroxyvitamin D is associated with irregular menstrual cycles in a cross-sectional study. Reprod Biol Endocrinol. 2015 Mar 11;13:20. doi: 10.1186/s12958-015-0012-5.

    PubMed 25879830

  • Protic O, Toti P, Islam MS, Occhini R, Giannubilo SR, Catherino WH, Cinti S, Petraglia F, Ciavattini A, Castellucci M, Hinz B, Ciarmela P. Possible involvement of inflammatory/reparative processes in the development of uterine fibroids. Cell Tissue Res. 2016 May;364(2):415-27. doi: 10.1007/s00441-015-2324-3. Epub 2015 Nov 27.

    PubMed 26613601

  • Skowronska P, Pastuszek E, Kuczynski W, Jaszczol M, Kuc P, Jakiel G, Woclawek-Potocka I, Lukaszuk K. The role of vitamin D in reproductive dysfunction in women - a systematic review. Ann Agric Environ Med. 2016 Dec 23;23(4):671-676. doi: 10.5604/12321966.1226865.

    PubMed 28030942

  • Holick MF. Vitamin D: A millenium perspective. J Cell Biochem. 2003 Feb 1;88(2):296-307. doi: 10.1002/jcb.10338.

    PubMed 12520530

  • Ali, M. et al. Vitamin D synergizes the antiproliferative, apoptotic, antifibrotic and anti-inflammatory effects of ulipristal acetate against human uterine fibroids Fertility and Sterility, Volume 108, Issue 3, e66

  • Hartmann KE, Fonnesbeck C, Surawicz T, Krishnaswami S, Andrews JC, Wilson JE, Velez-Edwards D, Kugley S, Sathe NA. Management of Uterine Fibroids [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2017 Dec. Report No.: 17(18)-EHC028-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK537742/

    PubMed 30789683

  • Munro MG, Critchley HO, Broder MS, Fraser IS; FIGO Working Group on Menstrual Disorders. FIGO classification system (PALM-COEIN) for causes of abnormal uterine bleeding in nongravid women of reproductive age. Int J Gynaecol Obstet. 2011 Apr;113(1):3-13. doi: 10.1016/j.ijgo.2010.11.011. Epub 2011 Feb 22.

    PubMed 21345435

  • Styer AK, Rueda BR. The Epidemiology and Genetics of Uterine Leiomyoma. Best Pract Res Clin Obstet Gynaecol. 2016 Jul;34:3-12. doi: 10.1016/j.bpobgyn.2015.11.018. Epub 2015 Dec 2.

    PubMed 26725703

Questions about this trial

What is this clinical trial studying?

An observational study of Leiomyoma and Vitamin D Deficiency, run by Instituto Mexicano del Seguro Social at 2 sites in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

appointment for intervention (time frame: 15 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04030182, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021.

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