Vitamin D and Microvascular Function in Postmenopausal Women

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.

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Key information

Conditions

Menopause Related Conditions Avitaminosis Cardiovascular Diseases Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Vitamin D Deficiency

Age range

45 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

State University of Rio de Janeiro

Rio de Janeiro, 20559900, Brazil

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Blood samples and Microvascular function assessment evaluated through laser-Doppler flowmetry by the LASER speckle contrast analysis (LASCA) device

Diagnostic Test

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

Primary outcomes

Vitamin D status and microvascular function

Time frame: 1 day

Vitamin D status and its relation to microvascular function and conventional cardiovascular risk (CVR) factors in postmenopausal women.

Sponsors and collaborators

Lead sponsor

Rio de Janeiro State University

Other

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: Jun 7, 2022
Registry last updated: Jun 7, 2022

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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