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Menopause Related ConditionsNCT05408273

Vitamin D and Microvascular Function in Postmenopausal Women

An observational study of Menopause Related Conditions and Vitamin D Deficiency, run by Rio de Janeiro State University at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 60 years, women onlyHealthy volunteers can take part
What is being tested?
Blood samples and Microvascular function assessment evaluated through laser-Doppler flowmetry by the LASER speckle contrast analysis (LASCA) device
How many people
88 participants
Where
1 siteBrazil
Study dates
4 Jul 2019to 17 Dec 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 60 years
  • Women only
  • Healthy volunteers accepted
  • Adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • State University of Rio de Janeiro

    Rio de Janeiro, 20559900

Other trials in Brazil

About this study

Official title: Vitamin D Effects on Microvascular Function and Cardiovascular Risk Factors on 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.

Being tested
Blood samples and Microvascular function assessment evaluated through laser-Doppler flowmetry by the LASER speckle contrast analysis (LASCA) device
Keywords
Menopause, Vitamin D, Microvascular Circulation, Laser Doppler Flowmetry
Medical subject headings
Vitamin D Deficiency, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05408273
Study groupRoleWhat they receive
Postmenopausal womenAssociations 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.
Receives: Diagnostic Test: Blood samples and Microvascular function assessment evaluated through laser-Doppler flowmetry by the LASER speckle contrast analysis (LASCA) device

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2022
  2. Study start4 Jul 2019
  3. Primary completion17 Dec 2021
  4. Study completion17 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05408273
Sponsor's protocol ID
31448514.1.0000.5282
Status last verified
Jun 2022
First submitted
31 May 2022
Last updated
7 Jun 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 32022580

  • 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.

    PubMed 25515034

  • 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.

    PubMed 16367934

  • 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.

    PubMed 20795937

  • 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.

    PubMed 16684613

  • 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.

    PubMed 34090775

  • 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.

    PubMed 24284821

  • 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.

    PubMed 22677566

  • 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.

    PubMed 32098418

  • 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.

    PubMed 29169589

Questions about this trial

What is this clinical trial studying?

An observational study of Menopause Related Conditions and Vitamin D Deficiency, run by Rio de Janeiro State University at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vitamin D status and microvascular function (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05408273, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2022.

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