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Vitamin D Deficit in Women With Uterine Fibroids

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ClinicalTrials.gov Identifier: NCT04030182
Recruitment Status : Recruiting
First Posted : July 23, 2019
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Luis Esteban González Varela, Instituto Mexicano del Seguro Social

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

Condition or disease Intervention/treatment
Leiomyoma Vitamin D Deficiency Fibroid Uterus Diagnostic Test: Level of Vitamin D

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.

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Study Type : Observational
Estimated Enrollment : 196 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Vitamin D Deficit in Women With Uterine Fibroids
Actual Study Start Date : December 1, 2019
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Group/Cohort Intervention/treatment
Level of vitamin D
Level in blood sample of vitamin D for each patient
Diagnostic Test: Level of Vitamin D
3 ml of venous blood will be taken to determine the level of vitamin D




Primary Outcome Measures :
  1. appointment for intervention [ Time Frame: 15 minutes ]

    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.



Biospecimen Retention:   Samples Without DNA
3 ml of venous blood sample to determine levels of vitamin D


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women with uterus and diagnosis of Uterine Leyomioma
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  • Female
  • Diagnosis of uterine fibroid

Exclusion Criteria:

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

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): NCT04030182


Contacts
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Contact: LUIS ESTEBAN GONZALEZ VARELA, PhD +523312615736 invacemjal@hotmail.com
Contact: Yovana Marisol Gutiérrez Arias, PhD +5212345155 yovanadelen@hotmail.com

Locations
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Mexico
Centro Médico Nacional de Occidente, Hospital de Gineco-Obstetricia Recruiting
Guadalajara, Jalisco, Mexico, 44600
Contact: Ana Fernanda Gómez Romero, PhD    +526671170105      
Contact: Gustavo Altamirano Briseño, PhD    +523331576042      
Hospital General Regional No. 45 Recruiting
Guadalajara, Jalisco, Mexico, 44600
Contact: Luis Esteban González Varela, MD    +5213312615736    invacemjal@hotmail.com   
Contact: Yovana Marisol Gutiérrez Arias, MD    +5212345155    yovanadelen@hotmail.com   
Sponsors and Collaborators
Instituto Mexicano del Seguro Social
Publications of Results:
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

Other Publications:
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Responsible Party: Luis Esteban González Varela, Gynecology Specialist, Adscript to the Gynecology Service in Regional General Hospital #45, Instituto Mexicano del Seguro Social
ClinicalTrials.gov Identifier: NCT04030182    
Other Study ID Numbers: VIDANFI
First Posted: July 23, 2019    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020

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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
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
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents