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Completed

NCT Number: NCT04030182

Vitamin D Deficit in Women With Uterine Fibroids

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

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Key information

Conditions

Leiomyoma Avitaminosis Deficiency Diseases Fibroid Uterus Malnutrition Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Nutrition Disorders Nutritional and Metabolic Diseases Vitamin D Deficiency

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Centro Médico Nacional de Occidente, Hospital de Gineco-Obstetricia, Guadalajara, Jalisco, Mexico

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female
  • Diagnosis of uterine fibroid

Exclusion criteria

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

Treatment and study plan

Level of Vitamin D

Diagnostic Test

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Instituto Mexicano del Seguro Social

Other Gov

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 23, 2019
Registry last updated
Nov 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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