NCT05689632

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 19, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2023

Completed
Last Updated

January 19, 2023

Status Verified

January 1, 2023

Enrollment Period

1 year

First QC Date

January 10, 2023

Last Update Submit

January 10, 2023

Conditions

ObesityVitamin D3 Deficiency

Keywords

ObesityVitamin D3 DeficiencyVitamin KSympathetic tonusEndothelial dysfunctionArterial stiffness

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Central blood pressure

    150 minutes

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo - Medium-chain triglyceride

Dietary Supplement: Placebo

Vitamin D3

ACTIVE COMPARATOR

Vitamin D3 - 7000 IU daily

Dietary Supplement: Vitamin D3

Vitamin D3 + K2-MK7

EXPERIMENTAL

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

Dietary Supplement: Vitamin D3 + K2-MK7

Interventions

Vitamin D3 + K2-MK7DIETARY_SUPPLEMENT

Combined supplementation

Vitamin D3 + K2-MK7
PlaceboDIETARY_SUPPLEMENT

MCT

Placebo
Vitamin D3DIETARY_SUPPLEMENT

Vitamin D3 - 7000 IU

Vitamin D3

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rio de Janeiro State University

Rio de Janeiro, 20551-030, Brazil

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Adriana C Faria, MD

    State University of Rio de Janeiro

    PRINCIPAL INVESTIGATOR

  • Mario F Neves, MD, PhD

    State University of Rio de Janeiro

    STUDY DIRECTOR

Central Study Contacts

Adriana C Faria, MD

CONTACT

5521999834054afmenie@gmail.com

Mario F Neves, MD, PhD

CONTACT

mariofneves@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The participants and the investigator do not know which supplements are taken.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, randomized, placebo-controlled, double-blind study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
FULL PROFESSOR

Study Record Dates

First Submitted

January 10, 2023

First Posted

January 19, 2023

Study Start

July 15, 2022

Primary Completion

July 15, 2023

Study Completion

November 15, 2023

Last Updated

January 19, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

No plans to share IPD with other researchers

Locations

BR(1)