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

Hospital Universitario Pedro Ernesto

Status: Enrolling

Conditions: Obesity; Vitamin D3 Deficiency

Treatments: Dietary Supplement: Vitamin D3; Dietary Supplement: Placebo; Dietary Supplement: Vitamin D3 + K2-MK7

Study type: Interventional

Funder types: Other

Identifiers

NCT05689632

CVH-D3K2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Vitamin D deficiency;
• Vitamin D insufficiency;
• Obesity;
• Overweight;

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo - Medium-chain triglyceride

Treatment:

Dietary Supplement: Placebo

Vitamin D3

Active Comparator group

Description:

Vitamin D3 - 7000 IU daily

Treatment:

Dietary Supplement: Vitamin D3

Vitamin D3 + K2-MK7

Experimental group

Description:

Vitamin D3 - 7000 IU + Vitamin K2-MK7 180mcg combined, daily

Treatment:

Dietary Supplement: Vitamin D3 + K2-MK7