Clinical trial NCT02959762: Vitamin K to Slow Progression of Dyslipidemia and Diabetes Risk (Vita-K 'n' Kids Study II)
Official title: Vitamin K to Slow Progression of Dyslipidemia and Diabetes Risk
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Insulin Resistance
Obesity in Diabetes
Nutritional and Metabolic Diseases
Hyperlipidemia
Hyperglycemia
Cardiovascular Diseases
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]
N01.224.425.525 [Nutritional Status]
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2016-11-09
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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).


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in serum lipid concentrations
timeFrame: 8 weeks
measure: Change in insulin sensitivity
timeFrame: 8 weeks
measure: Change in beta-cell function
timeFrame: 8-weeks
Secondary outcomes:
measure: Change in coagulation
timeFrame: 8 weeks
measure: Change in arterial stiffness (pulse wave velocity)
timeFrame: 8 weeks
measure: Change in endothelial function (flow-mediated dilation)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Medical College of Georgia; Augusta University
state: Georgia
Study officials:
affiliation: Department of Pediatrics, Medical College of Georgia, Augusta University
name: Norman K Pollock, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.