Vitamin D and Microvascular Function in Postmenopausal Women

NCT05408273 | Completed

• 1 other identifier: 31448514.1.0000.5282
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause Related Conditions; Vitamin D Deficiency; Cardiovascular Diseases

Keywords

Menopause; Vitamin D; Microvascular Circulation; Laser Doppler Flowmetry

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Postmenopausal women

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

Interventions

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

Postmenopausal women

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

State University of Rio de Janeiro

Rio de Janeiro, 20559900, Brazil

Location

Related Publications (10)

• 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.

  PMID: 32022580 BACKGROUND

• 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.

  PMID: 25515034 BACKGROUND

• 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.

  PMID: 16367934 BACKGROUND

• 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.

  PMID: 20795937 BACKGROUND

• 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.

  PMID: 16684613 BACKGROUND

• 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.

  PMID: 34090775 BACKGROUND

• 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.

  PMID: 24284821 BACKGROUND

• 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.

  PMID: 22677566 BACKGROUND

• 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.

  PMID: 32098418 BACKGROUND

• 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.

  PMID: 29169589 BACKGROUND

MeSH Terms

Conditions

Vitamin D Deficiency; Cardiovascular Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator on the Clinical and Experimental Pathophysiology Program

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 7, 2022
• Study Start: July 4, 2019
• Primary Completion: December 17, 2021
• Study Completion: December 17, 2021
• Last Updated: June 7, 2022

Record last verified: 2022-06

Locations

BR (1)