ObesityNCT05689632
Vitamins D and K Effects on Vascular Function in Obese Adults.
A study testing Vitamin D3 + K2-MK7 and Vitamin D3 in people with Obesity and Vitamin D3 Deficiency, run by Hospital Universitario Pedro Ernesto at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Vitamin D3 Deficiency
- What is being tested?
- Vitamin D3 + K2-MK7 and Vitamin D3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Jul 2022to 15 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Vitamin D deficiency;
- Vitamin D insufficiency;
- Obesity;
- Overweight;
Who cannot join
- Diabetes mellitus;
- Arterial coronary disease;
- Beta blocker use;
- cancer;
- ESRD;
Trial locations and contacts
1 site in 1 country.
Mario F Neves, MD, PhD contact
Brazil1 site, 1 recruiting
- Recruiting
Rio de Janeiro State University
Rio de Janeiro, 20551-030
Adriana C Faria, MD, 5521999834054, afmenie@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity, Vitamin D3 Deficiency
- Being tested
- Vitamin D3 + K2-MK7, Placebo, Vitamin D3
- Keywords
- Obesity, Vitamin D3 Deficiency, Vitamin K, Sympathetic tonus, Endothelial dysfunction, Arterial stiffness
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3 + K2-MK7Dietary supplement
Combined supplementation
PlaceboDietary supplement
MCT
Vitamin D3Dietary supplement
Vitamin D3 - 7000 IU
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo - Medium-chain triglyceride Receives: Dietary Supplement: Placebo |
| Vitamin D3 | Active comparator | Vitamin D3 - 7000 IU daily Receives: Dietary Supplement: Vitamin D3 |
| Vitamin D3 + K2-MK7 | Experimental | Vitamin D3 - 7000 IU + Vitamin K2-MK7 180mcg combined, daily Receives: Dietary Supplement: Vitamin D3 + K2-MK7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 150 minutes
Secondary outcomes (1)
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.
Measured: 150 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start15 Jul 2022
- Primary completion15 Jul 2023 (estimated)
- Study completion15 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, placebo-controlled, double-blind study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Pedro Ernesto
- Sponsor type
- University, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ), Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Mario Fritsch Neves, Hospital Universitario Pedro Ernesto
- Investigators
- Adriana C Faria, MD, Principal investigator, State University of Rio de JaneiroMario F Neves, MD, PhD, Study director, State University of Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689632
- Sponsor's protocol ID
- CVH-D3K2
- Status last verified
- Jan 2023
- First submitted
- 10 Jan 2023
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans to share IPD with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vitamin D3 and Vitamin K2MK7 Supplementation on Vascular Function in Overweight or Obese Adults.
- ClinicalTrials.gov ID
- NCT05689632
- Acronym / sponsor ID
- CVH-D3K2
- Conditions
- Obesity, Vitamin D3 Deficiency
- Keywords
- Obesity, Vitamin D3 Deficiency, Vitamin K, Sympathetic tonus, Endothelial dysfunction, Arterial stiffness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital Universitario Pedro ErnestoUniversity, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ), Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 15 Jul 2023 (estimated)
- Study completion
- 15 Nov 2023 (estimated)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective, randomized, placebo-controlled, double-blind study
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo - Medium-chain triglyceride |
| Vitamin D3 | Active comparator | Dietary Supplement: Vitamin D3Vitamin D3 - 7000 IU daily |
| Vitamin D3 + K2-MK7 | Experimental | Dietary Supplement: Vitamin D3 + K2-MK7Vitamin D3 - 7000 IU + Vitamin K2-MK7 180mcg combined, daily |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Vitamin D deficiency;
- Vitamin D insufficiency;
- Obesity;
- Overweight;
Key exclusion criteria (5 listed)
- Diabetes mellitus;
- Arterial coronary disease;
- Beta blocker use;
- cancer;
- ESRD;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3 + K2-MK7Combined supplementation | Dietary supplement | Vitamin D3 + K2-MK7 |
| PlaceboMCT | Dietary supplement | Placebo |
| Vitamin D3Vitamin D3 - 7000 IU | Dietary supplement | Vitamin D3 |
Primary outcome
Microvascular reactivity
Time frame: 150 minutes
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.
1 secondary outcome
Central blood pressure
Time frame: 150 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Individual participant dataSharing planned: No. No plans to share IPD with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario F Neves, MD, PhD contact
Adriana C Faria, MD principal investigator
State University of Rio de Janeiro
Mario F Neves, MD, PhD study director
State University of Rio de Janeiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 + K2-MK7 and Vitamin D3 in people with Obesity and Vitamin D3 Deficiency, run by Hospital Universitario Pedro Ernesto at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adriana C Faria, MD (5521999834054, afmenie@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microvascular reactivity (time frame: 150 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2023.