Vitamin D and Microvascular Function in Postmenopausal Women

Study Overview
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Brief Summary
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Many observational studies have demonstrated links between serum levels of 25-hydroxyvitamin D [25(OH)D] and cardiovascular risk (CVR) factors. Microvascular dysfunction relates not only to CVR but also to metabolic disease. Since cardiovascular disease (CVD) is the leading cause of death in postmenopausal women, it would be relevant to confirm this relationship. Maybe further studies would show that the correction of hypovitaminosis D could minimize the CVR. Our objective with this clinical trail is to analyze if vitamin D status is related to microvascular function and conventional cardiovascular risk (CVR) factors in postmenopausal women. For that we enrolled, in a pilot cross-sectional study, 39 non-smokers, low CVR postmenopausal women, with less than 10 years of hypoestrogenism and associations of 25(OH)D to adiposity, blood pressure, fasting aldosterone, insulin, glucose and lipid profile, HOMA-IR, parathormone and microvascular function, assessed by laser-Doppler flowmetry at cutaneous site, were investigated.

Official Title
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Vitamin D Effects on Microvascular Function and Cardiovascular Risk Factors on Postmenopausal Women

Conditions
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Menopause Related Conditions, Vitamin D Deficiency, Cardiovascular Diseases

Intervention / Treatment
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* Diagnostic Test: Blood samples and Microvascular function assessment evaluated through laser-Doppler flowmetry by the LASER speckle contrast analysis (LASCA) device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women between 45-60 years with clinical/laboratory criteria of menopause and duration of hypoestrogenism < 10 years. Menopause was spontaneous (at least one year of amenorrhea) or surgical (after bilateral oophorectomy). In hysterectomized women, ovarian failure was estimated by the history of vasomotor symptoms and serum levels of follicle-stimulating hormone (FSH) > 35 mU/mL and estradiol levels <20 pg/mL. Exclusion Criteria: Current smokers, body mass index (BMI) >35 kg/m², systolic BP >160 mmHg and or diastolic BP > 100 mmHg, total cholesterol >280 mg/dL, presence of T2D, renal dysfunction and or liver disease, clinical manifestations of coronary heart disease, and previous history of revascularization or cardiovascular event.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Postmenopausal women<br>Associations of 25(OH)D to adiposity, blood pressure, fasting aldosterone, insulin, glucose and lipid profile, HOMA-IR, parathormone and microvascular function, assessed by laser-Doppler flowmetry at cutaneous site, were investigated. | Diagnostic Test: Blood samples and Microvascular function assessment evaluated through laser-Doppler flowmetry by the LASER speckle contrast analysis (LASCA) device<br>* We enrolled 39 non-smokers, low CVR postmenopausal women, with less than 10 years of hypoestrogenism. Associations of 25(OH)D to adiposity, blood pressure, fasting aldosterone, insulin, glucose and lipid profile, HOMA-IR, parathormone and microvascular function, assessed by laser-Doppler flowmetry at cutaneous site, were investigated<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D status and microvascular function | Vitamin D status and its relation to microvascular function and conventional cardiovascular risk (CVR) factors in postmenopausal women. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Menopause, Vitamin D, Microvascular Circulation, Laser Doppler Flowmetry