Clinical trial NCT05408273: Vitamin D and Microvascular Function in Postmenopausal Women
Official title: Vitamin D Effects on Microvascular Function and Cardiovascular Risk Factors on Postmenopausal Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menopause Related Conditions
Vitamin D Deficiency
Cardiovascular Diseases
Keywords: Menopause
Vitamin D
Microvascular Circulation
Laser Doppler Flowmetry
Lead sponsor: Rio de Janeiro State University
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Rio de Janeiro State Research Supporting Foundation (FAPERJ)
First posted: 2022-06-07
Enrollment: 88
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Women from the gonad outpatient clinic of the Teaching Unit Endocrinology Department at Pedro Ernesto University Hospital/University of State of Rio de Janeiro, which integrates the state network of the Unified Health System, and volunteers who may be recruited from other HUPE Services or externally.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Vitamin D status and microvascular function
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Rio De Janeiro
country: Brazil
facility: State University of Rio de Janeiro
Study officials:
References:
citation: Rosenberry R, Nelson MD. Reactive hyperemia: a review of methods, mechanisms, and considerations. Am J Physiol Regul Integr Comp Physiol. 2020 Mar 1;318(3):R605-R618. doi: 10.1152/ajpregu.00339.2019. Epub 2020 Feb 5.
citation: Zhang QY, Jiang CM, Sun C, Tang TF, Jin B, Cao DW, He JS, Zhang M. Hypovitaminosis D is associated with endothelial dysfunction in patients with non-dialysis chronic kidney disease. J Nephrol. 2015 Aug;28(4):471-6. doi: 10.1007/s40620-014-0167-8. Epub 2014 Dec 17.
citation: Equils O, Naiki Y, Shapiro AM, Michelsen K, Lu D, Adams J, Jordan S. 1,25-Dihydroxyvitamin D inhibits lipopolysaccharide-induced immune activation in human endothelial cells. Clin Exp Immunol. 2006 Jan;143(1):58-64. doi: 10.1111/j.1365-2249.2005.02961.x.
citation: Brewer LC, Michos ED, Reis JP. Vitamin D in atherosclerosis, vascular disease, and endothelial function. Curr Drug Targets. 2011 Jan;12(1):54-60. doi: 10.2174/138945011793591617.
citation: Napoli C, de Nigris F, Williams-Ignarro S, Pignalosa O, Sica V, Ignarro LJ. Nitric oxide and atherosclerosis: an update. Nitric Oxide. 2006 Dec;15(4):265-79. doi: 10.1016/j.niox.2006.03.011. Epub 2006 Apr 15.
citation: Vinet A, Morrissey C, Perez-Martin A, Goncalves A, Raverdy C, Masson D, Gayrard S, Carrere M, Landrier JF, Amiot MJ. Effect of vitamin D supplementation on microvascular reactivity in obese adolescents: A randomized controlled trial. Nutr Metab Cardiovasc Dis. 2021 Jul 22;31(8):2474-2483. doi: 10.1016/j.numecd.2021.04.025. Epub 2021 May 10.
citation: Andrukhova O, Slavic S, Zeitz U, Riesen SC, Heppelmann MS, Ambrisko TD, Markovic M, Kuebler WM, Erben RG. Vitamin D is a regulator of endothelial nitric oxide synthase and arterial stiffness in mice. Mol Endocrinol. 2014 Jan;28(1):53-64. doi: 10.1210/me.2013-1252. Epub 2013 Jan 1.
citation: Codoner-Franch P, Tavarez-Alonso S, Simo-Jorda R, Laporta-Martin P, Carratala-Calvo A, Alonso-Iglesias E. Vitamin D status is linked to biomarkers of oxidative stress, inflammation, and endothelial activation in obese children. J Pediatr. 2012 Nov;161(5):848-54. doi: 10.1016/j.jpeds.2012.04.046. Epub 2012 Jun 5.
citation: Kim DH, Meza CA, Clarke H, Kim JS, Hickner RC. Vitamin D and Endothelial Function. Nutrients. 2020 Feb 22;12(2):575. doi: 10.3390/nu12020575.
citation: Schmitt EB, Nahas-Neto J, Bueloni-Dias F, Poloni PF, Orsatti CL, Petri Nahas EA. Vitamin D deficiency is associated with metabolic syndrome in postmenopausal women. Maturitas. 2018 Jan;107:97-102. doi: 10.1016/j.maturitas.2017.10.011. Epub 2017 Oct 18.