Trial | NCT01972113  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    menaquinone ...

  • Study Participants

    30
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 Started
Sep 30
2013
Primary Completion
Aug 30
2020
Anticipated
Study Completion
Dec 30
2020
Anticipated
Last Update
Nov 19
2019

Dietary Supplement Placebo-Control

one placebo softgel capsules per day (for 8 weeks) containing no vitamin K2 (menaquinone-7)

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

one 45-mcg vitamin K2 (menaquinone-7) softgel capsule per day and one placebo softgel per day (containing no menaquinone-7) for 8 weeks

  • Other names: menaquinone-7

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

one 90-mcg vitamin K2 (menaquinone-7) softgel capsules per day for 8 weeks

  • Other names: menaquinone-7

Placebo-Control Placebo Comparator

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

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.

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.

Criteria 

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
No Results Posted