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Vitamins D and K Effects on Vascular Function in Obese Adults.

Effects of Vitamin D3 and Vitamin K2MK7 Supplementation on Vascular Function in Overweight or Obese Adults.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05689632
Enrollment
100
Registered
2023-01-19
Start date
2022-07-15
Completion date
2023-11-15
Last updated
2023-01-19

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

Conditions

Obesity, Vitamin D3 Deficiency

Keywords

Obesity, Vitamin D3 Deficiency, Vitamin K, Sympathetic tonus, Endothelial dysfunction, Arterial stiffness

Brief summary

A prospective, randomized, placebo-controlled, double-blind study that aims to evaluate the effects of combined vitamin D3 and K2-MK7 supplementation on vascular function, sympathetic tone, metabolic biomarkers and inflammatory factors in a population of overweight or obese adults and deficient or insufficient serum levels of vitamin D.

Detailed description

Overweight and obesity are public health issues of epidemic proportions nowadays. They constitute risk factors for several chronic diseases with vascular, metabolic, and inflammatory changes. Adequate serum levels of vitamin D are correlated with good cardiovascular and metabolic health, since its deficiency and insufficiency (highly prevalent in obesity) have an inverse correlation. Likewise, vitamin K, especially K2, is related to the reduction of arterial stiffness, suppression of the inflammation in the vascular wall, favorable action on the lipid profile, whereas insufficiency is related to increased cardiovascular risk. The combined use of vitamin D and K aiming to reduce cardiovascular risk has been studied, however, the results of randomized clinical trials are still controversial. This prospective, randomized, placebo-controlled, double-blind trial aims to evaluate the effect of supplementation of vitamins D3 and K2-MK7 on vascular function, sympathetic tone, metabolic biomarkers and inflammatory factors in a population of overweight or obese adults and serum levels of deficient or insufficient vitamin D. Individuals of both sexes, aged between 40 and 70 years, body mass index (BMI) ≥ 25 and \< 40 kg/m² and vitamin 25OHD3 \<30 ng/ml will be randomized into 3 groups (A/B/C) to receive supplementation (Placebo/VitD3 7000 IU/VitD3 7000IU+K2-MK7-180mcg) daily for 16 weeks. Individuals will be rated at 4 visits namely: * V0 screening according to inclusion and exclusion criteria; clinical, anthropometry and electrical bioimpedance, laboratory and vascular evaluation before supplementation; * V1 supplementation begins; * V2 after 8 weeks; * V3 at the end of the intervention. The laboratory evaluation consists of blood count, biochemistry, electrolytes, glucose, lipid, liver and thyroid profiles, vitamin D3 and parathyroid hormone, in addition to the urinary excretion of calcium and creatinine. Sympathetic tone is assessed by a frequency meter (Polar® Verity Sense), arterial stiffness by measuring the pulse wave velocity by oscillometry (Mobil-O-Graph®) and endothelium function by measuring post-occlusion microvascular reactivity using laser speckle contrast image-LSCI.

Interventions

DIETARY_SUPPLEMENTVitamin D3 + K2-MK7

Combined supplementation

DIETARY_SUPPLEMENTPlacebo

MCT

DIETARY_SUPPLEMENTVitamin D3

Vitamin D3 - 7000 IU

Sponsors

Rio de Janeiro State Research Supporting Foundation (FAPERJ)
CollaboratorOTHER_GOV
Conselho Nacional de Desenvolvimento Científico e Tecnológico
CollaboratorOTHER_GOV
Hospital Universitario Pedro Ernesto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The participants and the investigator do not know which supplements are taken.

Intervention model description

Prospective, randomized, placebo-controlled, double-blind study

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Vitamin D deficiency; * Vitamin D insufficiency; * Obesity; * Overweight;

Exclusion criteria

* Diabetes mellitus; * Arterial coronary disease; * Beta blocker use; * cancer; * ESRD;

Design outcomes

Primary

MeasureTime frameDescription
Microvascular reactivity150 minutesA laser speckle contrast imaging system with a laser wavelength of 785 nm system will measure non-invasively real time cutaneous microvascular flow changes in the forearm. For the post occlusive reactive hyperemia test, arterial occlusion will be performed with suprasystolic pressure (50 mmHg above the systolic arterial pressure) using a sphygmomanometer applied to the arm of the subject over three minutes. Peak skin flow will be measured after pressure release.

Secondary

MeasureTime frameDescription
Central blood pressure150 minutesCentral systolic blood pressure, diastolic blood pressure, mean arterial pressure and pulse pressure before and after intervention and their potential effects on changes in subendocardial viability ratio and ejection duration after intervention with beetroot juice and water.

Countries

Brazil

Contacts

Primary ContactAdriana C Faria, MD
afmenie@gmail.com5521999834054
Backup ContactMario F Neves, MD, PhD
mariofneves@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026