Vitamin K and Glucose Metabolism in Children at Risk for Diabetes (Vita-K 'n' Kids Study)

Augusta University

Status: Unknown

Conditions: Prediabetes; Diabetes; Insulin Resistance; Obesity; Dyslipidemia; Insulin Sensitivity

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01972113

16GRNT31090037 (Other Grant/Funding Number)

611523 (Pro00000912)

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 8 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

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 one 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 one 90-mcg vitamin K2 softgel capsules every day for 8 weeks.

Treatment:

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