ObesityNCT02959762
Vitamin K to Slow Progression of Dyslipidemia and Diabetes Risk (Vita-K 'n' Kids Study II)
A study testing Low-Dose Vitamin K2 (menaquinone-7; 45-mcg/d) and High-Dose Vitamin K2 (menaquinone-7; 90 mcg/d) in people with Obesity and Insulin Resistance, run by Augusta University at 1 site in United States.
Trial summary
Animal studies have found that vitamin K-dependent proteins matrix Gla protein and osteocalcin beneficially influence lipid and glucose metabolism, respectively. However, this concept has not been tested in humans at risk for dyslipidemia and diabetes risk. Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Insulin Resistance, Obesity in Diabetes
- What is being tested?
- Low-Dose Vitamin K2 (menaquinone-7; 45-mcg/d) and High-Dose Vitamin K2 (menaquinone-7; 90 mcg/d)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 30 Dec 2020
- 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 8 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 8 to 17 years
- Body mass index equal to or greater than 85th percentile for age and sex
- Subject and parent/guardian understands the study protocol and agrees to comply with it
- Informed Consent Form signed by the parent/guardian and assent signed by the subject
Who cannot join
- Subjects using vitamin supplements containing vitamin k
- Subjects with (a history of) metabolic or gastrointestinal diseases including hepatic disorders
- Subjects presenting chronic degenerative and/or inflammatory diseases
- Subjects receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters (salicylates, antibiotics)
- Subjects receiving corticosteroid treatment
- Subjects using oral anticoagulants
- Subjects with a history of soy allergy
- Subjects who have participated in a clinical study more recently than one month before the current study
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Georgia; Augusta University
Augusta, Georgia, 30912
About this study
Official title: Vitamin K to Slow Progression of Dyslipidemia and Diabetes Risk
Animal studies have found that vitamin K-dependent proteins matrix Gla protein and osteocalcin beneficially influence lipid and glucose metabolism, respectively. However, this concept has not been tested in humans at risk for dyslipidemia and diabetes risk. Vitamin K supplementation presents an opportunity to test the hypothesized link between the vitamin K-dependent proteins and markers of lipid and glucose metabolism. The investigators will conduct an 8-week vitamin K intervention (to manipulate carboxylation of matrix Gla protein and osteocalcin) and determine its effects on markers of dyslipidemia and diabetes risk. Sixty obese children will be randomly allocated to either the control group receiving placebo or the low-dose (45 mcg/d) or high-dose group (90 mcg/d) receiving vitamin K (menaquinone-7).
- Conditions
- Obesity, Insulin Resistance, Obesity in Diabetes, Nutritional and Metabolic Diseases, Hyperlipidemia, Hyperglycemia
- Being tested
- Placebo-Control, Low-Dose Vitamin K2 (menaquinone-7; 45-mcg/d), High-Dose Vitamin K2 (menaquinone-7; 90 mcg/d)
- Keywords
- G01 [Biological Sciences], G02.513 [Nutrition], G06.696.259 [Child Nutrition], G07.553.481.398.571 [Obesity], G06 [Biochemical Phenomena, Metabolism, and Nutrition], G12.392.617 [Insulin Resistance], G06.696.259.500 [Adolescent Nutrition], A06 [Endocrine System], A07 [Cardiovascular System], C18.452.297.681 [Obesity in Diabetes], C18.452.555 [Insulin Resistance], C18 [Nutritional and Metabolic Diseases], C18.452.494 [Hyperlipidemia], C18.452.460 [Hyperglycemia], C14 [Cardiovascular Diseases], D11.786.875.844 [Vitamin K 2], D02.806.550.750 [Vitamin K 2], E02.293 [Diet Therapy], E02 [Therapeutics], F04.096.544.215.508.428 [Primary Prevention]
- Medical subject headings
- Obesity, Insulin Resistance, Nutritional and Metabolic Diseases, Hyperlipidemias, Hyperglycemia, Cardiovascular Diseases, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo-ControlDietary supplement
two placebo softgel capsules per day (for 8 weeks) containing no vitamin K2 (menaquinone-7)
Low-Dose Vitamin K2 (menaquinone-7; 45-mcg/d)Dietary supplement
Also called menaquinone-7
one 45-mcg vitamin K2 (menaquinone-7) softgel capsule per day and one placebo softgel per day (containing no menaquinone-7) for 8 weeks
High-Dose Vitamin K2 (menaquinone-7; 90 mcg/d)Dietary supplement
Also called menaquinone-7
two 45-mcg vitamin K2 (menaquinone-7) softgel capsules per day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo-Control | Placebo comparator | The placebo-control group will take two placebo softgel capsules every day for 8 weeks. Receives: Dietary Supplement: Placebo-Control |
| Low-Dose Vitamin K2 (45-mcg/d) | Active comparator | The low-dose vitamin K2 group will take one 45-mcg vitamin K2 softgel capsule and one placebo softgel capsule every day for 8 weeks. Receives: Dietary Supplement: Low-Dose Vitamin K2 (menaquinone-7; 45-mcg/d) |
| High-Dose Vitamin K2 (90-mcg/d) | Active comparator | The high-dose vitamin K2 group will take two 45-mcg vitamin K2 softgel capsules every day for 8 weeks. Receives: Dietary Supplement: High-Dose Vitamin K2 (menaquinone-7; 90 mcg/d) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum lipid concentrations
To determine if the vitamin K-induced change in matrix Gla protein carboxylation improves fasting lipid panel (triglycerides, total cholesterol, HDL-cholesterol, and LDL-cholesterol) in a dose-dependent manner.
Measured: 8 weeks
Change in insulin sensitivity
To determine if the vitamin K-induced change in osteocalcin carboxylation effects insulin sensitivity in a dose-dependent manner. Insulin sensitivity will be calculated from plasma insulin and glucose concentrations measured during a two-hour oral glucose tolerance test by using the oral glucose minimal model.
Measured: 8 weeks
Change in beta-cell function
To determine if the vitamin K-induced change in osteocalcin carboxylation effects beta-cell function in a dose-dependent manner. Beta-cell function, as assessed by dynamic beta-cell responsitivity, will be calculated from plasma glucose and C-peptide concentrations measured during a two-hour oral glucose tolerance test by using the oral C-peptide minimal model.
Measured: 8-weeks
Secondary outcomes (3)
Change in coagulation
Coagulation-related parameters (i.e., prothrombin time and activated partial thromboplastin time) will be assessed at baseline and 8 weeks to assess clotting function.
Measured: 8 weeks
Change in arterial stiffness (pulse wave velocity)
Arterial stiffness, as measured by pulse wave velocity (PWV), will be assessed at baseline and 8 weeks to explore whether change in arterial stiffness is influenced by vitamin K2 supplementation.
Measured: 8 weeks
Change in endothelial function (flow-mediated dilation)
Endothelial function, as measured by flow-mediated dilation (FMD), will be assessed at baseline and 8 weeks to explore whether change in endothelial function is influenced by vitamin K2 supplementation.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study startOct 2016
- Primary completion1 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norman Pollock, Augusta University
- Investigators
- Norman K Pollock, PhD, Principal investigator, Department of Pediatrics, Medical College of Georgia, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02959762
- Sponsor's protocol ID
- 931430
- Other IDs
- 16GRNT31090037
- Status last verified
- Nov 2019
- First submitted
- 11 Oct 2016
- Last updated
- 20 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 1. Approximate date of when the data will be shared? 2019-06-28 2. Where will the data be made available? The de-identified data will be made available for research purposes only by contacting the principal investigator. 3. Please explain any limits to data sharing that might be required. Even though the final research data will be stripped of identifiers prior to release for sharing, the investigators believe that there remains the possibility of deductive disclosure of subjects with unusual characteristics. Thus, the investigators will make the data available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
Publications
Douthit MK, Fain ME, Nguyen JT, Williams CF, Jasti AH, Gutin B, Pollock NK. Phylloquinone Intake Is Associated with Cardiac Structure and Function in Adolescents. J Nutr. 2017 Oct 1;147(10):1960-1967. doi: 10.3945/jn.117.253666.
PubMed 28794209
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin K to Slow Progression of Dyslipidemia and Diabetes Risk
- ClinicalTrials.gov ID
- NCT02959762
- Acronym / sponsor ID
- 931430
- Conditions
- Obesity, Insulin Resistance, Obesity in Diabetes, Nutritional and Metabolic Diseases, Hyperlipidemia, Hyperglycemia
- Keywords
- G01 [Biological Sciences], G02.513 [Nutrition], G06.696.259 [Child Nutrition], G07.553.481.398.571 [Obesity], G06 [Biochemical Phenomena, Metabolism, and Nutrition], G12.392.617 [Insulin Resistance], G06.696.259.500 [Adolescent Nutrition], A06 [Endocrine System]
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 9 Nov 2016 (estimated)
- 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.
Animal studies have found that vitamin K-dependent proteins matrix Gla protein and osteocalcin beneficially influence lipid and glucose metabolism, respectively. However, this concept has not been tested in humans at risk for dyslipidemia and diabetes risk. Vitamin K supplementation presents an opportunity to test the hypothesized link between the vitamin K-dependent proteins and markers of lipid and glucose metabolism. The investigators will conduct an 8-week vitamin K intervention (to manipulate carboxylation of matrix Gla protein and osteocalcin) and determine its effects on markers of dyslipidemia and diabetes risk. Sixty obese children will be randomly allocated to either the control group receiving placebo or the low-dose (45 mcg/d) or high-dose group (90 mcg/d) receiving vitamin K (menaquinone-7).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo-Control | Placebo comparator | Dietary Supplement: Placebo-ControlThe placebo-control group will take two placebo softgel capsules every day for 8 weeks. |
| Low-Dose Vitamin K2 (45-mcg/d) | Active comparator | Dietary Supplement: Low-Dose Vitamin K2 (menaquinone-7; 45-mcg/d)The low-dose vitamin K2 group will take one 45-mcg vitamin K2 softgel capsule and one placebo softgel capsule every day for 8 weeks. |
| High-Dose Vitamin K2 (90-mcg/d) | Active comparator | Dietary Supplement: High-Dose Vitamin K2 (menaquinone-7; 90 mcg/d)The high-dose vitamin K2 group will take two 45-mcg vitamin K2 softgel capsules every day for 8 weeks. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 8 to 17 years
- Body mass index equal to or greater than 85th percentile for age and sex
- Subject and parent/guardian understands the study protocol and agrees to comply with it
- Informed Consent Form signed by the parent/guardian and assent signed by the subject
Key exclusion criteria (8 listed)
- Subjects using vitamin supplements containing vitamin k
- Subjects with (a history of) metabolic or gastrointestinal diseases including hepatic disorders
- Subjects presenting chronic degenerative and/or inflammatory diseases
- Subjects receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters (salicylates, antibiotics)
- Subjects receiving corticosteroid treatment
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 |
|---|---|---|
| Placebo-Controltwo placebo softgel capsules per day (for 8 weeks) containing no vitamin K2 (menaquinone-7) | Dietary supplement | Placebo-Control |
| Low-Dose Vitamin K2 (menaquinone-7; 45-mcg/d)Also: menaquinone-7one 45-mcg vitamin K2 (menaquinone-7) softgel capsule per day and one placebo softgel per day (containing no menaquinone-7) for 8 weeks | Dietary supplement | Low-Dose Vitamin K2 (45-mcg/d) |
| High-Dose Vitamin K2 (menaquinone-7; 90 mcg/d)Also: menaquinone-7two 45-mcg vitamin K2 (menaquinone-7) softgel capsules per day for 8 weeks | Dietary supplement | High-Dose Vitamin K2 (90-mcg/d) |
Primary outcome
Change in serum lipid concentrations
Time frame: 8 weeks
To determine if the vitamin K-induced change in matrix Gla protein carboxylation improves fasting lipid panel (triglycerides, total cholesterol, HDL-cholesterol, and LDL-cholesterol) in a dose-dependent manner.
Change in insulin sensitivity
Time frame: 8 weeks
To determine if the vitamin K-induced change in osteocalcin carboxylation effects insulin sensitivity in a dose-dependent manner. Insulin sensitivity will be calculated from plasma insulin and glucose concentrations measured during a two-hour oral glucose tolerance test by using the oral glucose minimal model.
Change in beta-cell function
Time frame: 8-weeks
To determine if the vitamin K-induced change in osteocalcin carboxylation effects beta-cell function in a dose-dependent manner. Beta-cell function, as assessed by dynamic beta-cell responsitivity, will be calculated from plasma glucose and C-peptide concentrations measured during a two-hour oral glucose tolerance test by using the oral C-peptide minimal model.
3 secondary outcomes
Change in coagulation
Time frame: 8 weeks
Change in arterial stiffness (pulse wave velocity)
Time frame: 8 weeks
Change in endothelial function (flow-mediated dilation)
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
- Background: PubMed 28794209Douthit MK, Fain ME, Nguyen JT, Williams CF, Jasti AH, Gutin B, Pollock NK. Phylloquinone Intake Is Associated with Cardiac Structure and Function in Adolescents. J Nutr. 2017 Oct 1;147(10):1960-1967. doi: 10.3945/jn.117.253666.
- Individual participant dataSharing planned: Yes. 1. Approximate date of when the data will be shared? 2019-06-28 2. Where will the data be made available? The de-identified data will be made available for research purposes only by contacting the principal investigator. 3. Please explain any limits to data sharing that might be required. Even though the final research data will be stripped of identifiers prior to release for sharing, the investigators believe that there remains the possibility of deductive disclosure of subjects with unusual characteristics. Thus, the investigators will make the data available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
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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.
Norman K Pollock, PhD principal investigator
Department of Pediatrics, Medical College of Georgia, Augusta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Dose Vitamin K2 (menaquinone-7; 45-mcg/d) and High-Dose Vitamin K2 (menaquinone-7; 90 mcg/d) in people with Obesity and Insulin Resistance, run by Augusta University at 1 site in United States.
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 8 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 20 Nov 2019. 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 United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum lipid concentrations (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02959762, which also lists 1 linked publication.
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 20 Nov 2019.