Vitamin K to Slow Progression of Dyslipidemia and Diabetes Risk (Vita-K 'n' Kids Study II)

Augusta University

Status: Unknown

Conditions: Hyperglycemia; Hyperlipidemia; Insulin Resistance; Obesity; Cardiovascular Diseases; Obesity in Diabetes; Nutritional and Metabolic Diseases

Treatments: Dietary Supplement: High-Dose Vitamin K2 (menaquinone-7; 90 mcg/d); Dietary Supplement: Low-Dose Vitamin K2 (menaquinone-7; 45-mcg/d); Dietary Supplement: Placebo-Control

Study type: Interventional

Funder types: Other

Identifiers

NCT02959762

16GRNT31090037 (Other Grant/Funding Number)

931430

Details and patient eligibility

About

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).

Enrollment: 30 estimated patients

Sex: All

Ages: 8 to 17 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 3 patient groups, including a placebo group

Placebo-Control

Placebo Comparator group

Description:

The placebo-control group will take two placebo softgel capsules every day for 8 weeks.

Treatment:

Dietary Supplement: Placebo-Control

Low-Dose Vitamin K2 (45-mcg/d)

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Low-Dose Vitamin K2 (menaquinone-7; 45-mcg/d)

High-Dose Vitamin K2 (90-mcg/d)

Active Comparator group

Description:

The high-dose vitamin K2 group will take two 45-mcg vitamin K2 softgel capsules every day for 8 weeks.

Treatment:

Dietary Supplement: High-Dose Vitamin K2 (menaquinone-7; 90 mcg/d)