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.

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Vitamin D3 Deficiency
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Vitamin D3; Dietary supplement: Vitamin D3 + K2-MK7

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adriana C Faria, MD; Phone Number: 5521999834054; Email: afmenie@gmail.com
• Study Contact Backup: Name: Mario F Neves, MD, PhD; Email: mariofneves@gmail.com

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 20551-030
    • Recruiting
    • Rio de Janeiro State University
    • Contact: Adriana C Faria, MD; Phone Number: 5521999834054; Email: afmenie@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo - Medium-chain triglyceride	Dietary supplement: Placebo; MCT
Active Comparator: Vitamin D3; Vitamin D3 - 7000 IU daily	Dietary supplement: Vitamin D3; Vitamin D3 - 7000 IU
Experimental: Vitamin D3 + K2-MK7; Vitamin D3 - 7000 IU + Vitamin K2-MK7 180mcg combined, daily	Dietary supplement: Vitamin D3 + K2-MK7; Combined supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microvascular reactivity	A 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.	150 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Central blood pressure	Central 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.	150 minutes

Collaborators and Investigators

• Sponsor: Hospital Universitario Pedro Ernesto
• Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico; Rio de Janeiro State Research Supporting Foundation (FAPERJ)
• Investigators: Study Director: Mario F Neves, MD, PhD, State University of Rio de Janeiro; Principal Investigator: Adriana C Faria, MD, State University of Rio de Janeiro

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Anticipated): July 15, 2023
• Study Completion (Anticipated): November 15, 2023

Study Registration Dates

• First Submitted: January 10, 2023
• First Submitted That Met QC Criteria: January 10, 2023
• First Posted (Actual): January 19, 2023

Study Record Updates

• Last Update Posted (Actual): January 19, 2023
• Last Update Submitted That Met QC Criteria: January 10, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Endothelial dysfunction; Obesity; Arterial stiffness; Vitamin K; Vitamin D3 Deficiency; Sympathetic tonus
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: CVH-D3K2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No plans to share IPD with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No