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Vitamin D and Microvascular Function in Postmenopausal Women

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05408273
Enrollment
88
Registered
2022-06-07
Start date
2019-07-04
Completion date
2021-12-17
Last updated
2022-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Menopause Related Conditions, Vitamin D Deficiency

Keywords

Menopause, Vitamin D, Microvascular Circulation, Laser Doppler Flowmetry

Brief summary

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.

Interventions

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

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

Sponsors

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

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
45 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Vitamin D status and microvascular function1 dayVitamin D status and its relation to microvascular function and conventional cardiovascular risk (CVR) factors in postmenopausal women.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026