Clinical trial NCT05689632: Vitamins D and K Effects on Vascular Function in Obese Adults.
Official title: Effects of Vitamin D3 and Vitamin K2MK7 Supplementation on Vascular Function in Overweight or Obese Adults.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Vitamin D3 Deficiency
Keywords: Obesity
Vitamin D3 Deficiency
Vitamin K
Sympathetic tonus
Endothelial dysfunction
Arterial stiffness
Lead sponsor: Hospital Universitario Pedro Ernesto
Sponsor class: OTHER
Collaborators: name: Rio de Janeiro State Research Supporting Foundation (FAPERJ)
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2023-01-19
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, placebo-controlled, double-blind study
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Microvascular reactivity
timeFrame: 150 minutes
Secondary outcomes:
measure: Central blood pressure
timeFrame: 150 minutes
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Rio de Janeiro State University
Study officials:
affiliation: State University of Rio de Janeiro
name: Adriana C Faria, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: State University of Rio de Janeiro
name: Mario F Neves, MD, PhD
role: STUDY_DIRECTOR
References: