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出境医 / 临床实验 / Vitamin D Deficit in Women With Uterine Fibroids
Vitamin D Deficit in Women With Uterine Fibroids
Study Description
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.
Study Design
| 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 |
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures :
- 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
Eligibility Criteria
| 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
Contacts and Locations
Contacts
| Contact: LUIS ESTEBAN GONZALEZ VARELA, PhD | +523312615736 | invacemjal@hotmail.com | |
| Contact: Yovana Marisol Gutiérrez Arias, PhD | +5212345155 | yovanadelen@hotmail.com |
Locations
| 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
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | July 2, 2019 | ||||||||
| First Posted Date | July 23, 2019 | ||||||||
| Last Update Posted Date | February 5, 2020 | ||||||||
| Actual Study Start Date | December 1, 2019 | ||||||||
| Estimated Primary Completion Date | October 30, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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.
|
||||||||
| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Vitamin D Deficit in Women With Uterine Fibroids | ||||||||
| Official Title | Vitamin D Deficit in Women With Uterine Fibroids | ||||||||
| 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 | ||||||||
| 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. | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Case-Only Time Perspective: Cross-Sectional |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples Without DNA Description:
3 ml of venous blood sample to determine levels of vitamin D
|
||||||||
| 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. |
||||||||
| Condition |
|
||||||||
| Intervention | Diagnostic Test: Level of Vitamin D
3 ml of venous blood will be taken to determine the level of vitamin D
|
||||||||
| Study Groups/Cohorts | Level of vitamin D
Level in blood sample of vitamin D for each patient
Intervention: Diagnostic Test: Level of Vitamin D
|
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| Publications * |
|
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
196 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | December 30, 2020 | ||||||||
| Estimated Primary Completion Date | October 30, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
||||||||
| Ages | 18 Years to 50 Years (Adult) | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts |
|
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| Listed Location Countries | Mexico | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04030182 | ||||||||
| Other Study ID Numbers | VIDANFI | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | Luis Esteban González Varela, Instituto Mexicano del Seguro Social | ||||||||
| Study Sponsor | Instituto Mexicano del Seguro Social | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators | Not Provided | ||||||||
| PRS Account | Instituto Mexicano del Seguro Social | ||||||||
| Verification Date | February 2020 | ||||||||
