ObesityNCT01972113
Vitamin K and Glucose Metabolism in Children at Risk for Diabetes (Vita-K 'n' Kids Study)
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
The undercarboxylated fractions of the two vitamin K-dependent proteins osteocalcin and matrix Gla protein have been shown to play key roles in type 2 diabetes and cardiovascular disease (at least in mouse models). 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, Insulin Sensitivity
- 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
- Sep 2013to 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
- BMI less than 85th percentile for age and gender
- 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, 1 recruiting
- Recruiting
Medical College of Georgia; Augusta University
Augusta, Georgia, 30909
Norman K Pollock, Ph.D.
About this study
Official title: Vitamin K and Glucose Metabolism in Children at Risk for Diabetes
The undercarboxylated fractions of the two vitamin K-dependent proteins osteocalcin and matrix Gla protein have been shown to play key roles in type 2 diabetes and cardiovascular disease (at least in mouse models). Clinical trials are needed to isolate the effects of vitamin K manipulation on carboxylation of these two proteins (osteocalcin and matrix GLA protein) and their subsequent effects on markers of diabetes and cardiovascular disease risk. The purpose of this pilot randomized, double-blind, placebo-controlled trial in children is to estimate the effective dose of vitamin K2 (menaquinone-7) supplementation (to improve carboxylation of both osteocalcin and matrix Gla protein), and whether it can have an effect on markers associated with diabetes and cardiovascular disease risk.
- Conditions
- Obesity, Insulin Resistance, Insulin Sensitivity, Prediabetes, Dyslipidemia, Diabetes
- Being tested
- Placebo-Control, Low-Dose Vitamin K2 (menaquinone-7; 45 mcg/d), High-Dose Vitamin K2 (menaquinone-7; 90 mcg/d)
- Keywords
- Vitamin K, Vitamin K2, Menaquinone-7, Osteocalcin, Children, Obesity, Insulin resistance, Insulin sensitivity, Beta-cell function, Prediabetes, Matrix Gla protein, Arterial stiffness, Endothelial function
- Medical subject headings
- Obesity, Insulin Resistance, Prediabetic State, Dyslipidemias, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo-ControlDietary supplement
one 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
one 90-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 one 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 one 90-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 vitamin K supplementation 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 vitamin K supplementation improves insulin sensitivity in a dose-dependent manner. Insulin sensitivity will be calculated from plasma insulin and glucose concentrations measured during a 2-hour glucose tolerance test by using the oral glucose minimal model.
Measured: 8 weeks
Change in beta-cell function
To determine if vitamin K supplementation improves insulin sensitivity 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 2-hour glucose tolerance test by using the oral C-peptide minimal model.
Measured: 8 weeks
Secondary outcomes (4)
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
Effects of sex, race, bone age, and pubertal stage on changes in glucosemetabolism (insulin sensitivity and beta-cell function)
Moderation effects of sex, race, bone age, and pubertal stage in the associations of vitamin K-induced changes in carboxylation of osteocalcin on markers of glucose metabolism will be determined.
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 posted30 Oct 2013 (estimated)
- Study startSep 2013
- Primary completion30 Aug 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 (6)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
- Collaborators
- University of Alabama at Birmingham, Yale University, Tufts University
- Responsible party
- Principal investigator, Norman Pollock, Augusta University
- Investigators
- Norman K Pollock, Ph.D., Principal investigator, Department of Medicine, Medical College of Georgia, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01972113
- Sponsor's protocol ID
- 611523 (Pro00000912)
- Other IDs
- 16GRNT31090037
- Status last verified
- Nov 2019
- First submitted
- 24 Oct 2013
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pollock NK, Bernard PJ, Gower BA, Gundberg CM, Wenger K, Misra S, Bassali RW, Davis CL. Lower uncarboxylated osteocalcin concentrations in children with prediabetes is associated with beta-cell function. J Clin Endocrinol Metab. 2011 Jul;96(7):E1092-9. doi: 10.1210/jc.2010-2731. Epub 2011 Apr 20.
PubMed 21508147Gower BA, Pollock NK, Casazza K, Clemens TL, Goree LL, Granger WM. Associations of total and undercarboxylated osteocalcin with peripheral and hepatic insulin sensitivity and beta-cell function in overweight adults. J Clin Endocrinol Metab. 2013 Jul;98(7):E1173-80. doi: 10.1210/jc.2013-1203. Epub 2013 Apr 24.
PubMed 23616149Booth SL, Centi A, Smith SR, Gundberg C. The role of osteocalcin in human glucose metabolism: marker or mediator? Nat Rev Endocrinol. 2013 Jan;9(1):43-55. doi: 10.1038/nrendo.2012.201. Epub 2012 Nov 13.
PubMed 23147574Pollock NK. Childhood obesity, bone development, and cardiometabolic risk factors. Mol Cell Endocrinol. 2015 Jul 15;410:52-63. doi: 10.1016/j.mce.2015.03.016. Epub 2015 Mar 27.
PubMed 25817542Douthit 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 28794209Fain ME, Kapuku GK, Paulson WD, Williams CF, Raed A, Dong Y, Knapen MHJ, Vermeer C, Pollock NK. Inactive Matrix Gla Protein, Arterial Stiffness, and Endothelial Function in African American Hemodialysis Patients. Am J Hypertens. 2018 May 7;31(6):735-741. doi: 10.1093/ajh/hpy049.
PubMed 29635270
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin K and Glucose Metabolism in Children at Risk for Diabetes
- ClinicalTrials.gov ID
- NCT01972113
- Acronym / sponsor ID
- 611523 (Pro00000912)
- Conditions
- Obesity, Insulin Resistance, Insulin Sensitivity, Prediabetes, Dyslipidemia, Diabetes
- Keywords
- Vitamin K, Vitamin K2, Menaquinone-7, Osteocalcin, Children, Obesity, Insulin resistance, Insulin sensitivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham, Yale University, Tufts University
- Study start
- Sep 2013
- Primary completion
- 30 Aug 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 30 Oct 2013 (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.
The undercarboxylated fractions of the two vitamin K-dependent proteins osteocalcin and matrix Gla protein have been shown to play key roles in type 2 diabetes and cardiovascular disease (at least in mouse models). Clinical trials are needed to isolate the effects of vitamin K manipulation on carboxylation of these two proteins (osteocalcin and matrix GLA protein) and their subsequent effects on markers of diabetes and cardiovascular disease risk. The purpose of this pilot randomized, double-blind, placebo-controlled trial in children is to estimate the effective dose of vitamin K2 (menaquinone-7) supplementation (to improve carboxylation of both osteocalcin and matrix Gla protein), and whether it can have an effect on markers associated with diabetes and cardiovascular disease risk.
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 one 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 one 90-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
- BMI less than 85th percentile for age and gender
- 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-Controlone 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-7one 90-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 vitamin K supplementation 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 vitamin K supplementation improves insulin sensitivity in a dose-dependent manner. Insulin sensitivity will be calculated from plasma insulin and glucose concentrations measured during a 2-hour glucose tolerance test by using the oral glucose minimal model.
Change in beta-cell function
Time frame: 8 weeks
To determine if vitamin K supplementation improves insulin sensitivity 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 2-hour glucose tolerance test by using the oral C-peptide minimal model.
4 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
Effects of sex, race, bone age, and pubertal stage on changes in glucosemetabolism (insulin sensitivity and beta-cell function)
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 19 Nov 2019.
- Background: PubMed 21508147Pollock NK, Bernard PJ, Gower BA, Gundberg CM, Wenger K, Misra S, Bassali RW, Davis CL. Lower uncarboxylated osteocalcin concentrations in children with prediabetes is associated with beta-cell function. J Clin Endocrinol Metab. 2011 Jul;96(7):E1092-9. doi: 10.1210/jc.2010-2731. Epub 2011 Apr 20.
- Background: PubMed 23616149Gower BA, Pollock NK, Casazza K, Clemens TL, Goree LL, Granger WM. Associations of total and undercarboxylated osteocalcin with peripheral and hepatic insulin sensitivity and beta-cell function in overweight adults. J Clin Endocrinol Metab. 2013 Jul;98(7):E1173-80. doi: 10.1210/jc.2013-1203. Epub 2013 Apr 24.
- Background: PubMed 23147574Booth SL, Centi A, Smith SR, Gundberg C. The role of osteocalcin in human glucose metabolism: marker or mediator? Nat Rev Endocrinol. 2013 Jan;9(1):43-55. doi: 10.1038/nrendo.2012.201. Epub 2012 Nov 13.
- Background: PubMed 25817542Pollock NK. Childhood obesity, bone development, and cardiometabolic risk factors. Mol Cell Endocrinol. 2015 Jul 15;410:52-63. doi: 10.1016/j.mce.2015.03.016. Epub 2015 Mar 27.
- 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.
- Background: PubMed 29635270Fain ME, Kapuku GK, Paulson WD, Williams CF, Raed A, Dong Y, Knapen MHJ, Vermeer C, Pollock NK. Inactive Matrix Gla Protein, Arterial Stiffness, and Endothelial Function in African American Hemodialysis Patients. Am J Hypertens. 2018 May 7;31(6):735-741. doi: 10.1093/ajh/hpy049.
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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, Ph.D. principal investigator
Department of Medicine, 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 19 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?
Contact Norman K Pollock, Ph.D. (706-721-5424, npollock@augusta.edu), or a site near the patient. 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 NCT01972113, which also lists 6 linked publications.
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 Nov 2019.