Vitamin K and Glucose Metabolism in Children at Risk for Diabetes (Vita-K 'n' Kids Study)
| Status: | Recruiting |
|---|---|
| Conditions: | High Cholesterol, Obesity Weight Loss, Neurology, Endocrine, Endocrine, Diabetes |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology, Neurology |
| Healthy: | No |
| Age Range: | 8 - 17 |
| Updated: | 7/14/2018 |
| Start Date: | September 2013 |
| End Date: | December 2018 |
| Contact: | Norman K Pollock, Ph.D. |
| Email: | npollock@augusta.edu |
| Phone: | 706-721-5424 |
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.
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.
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
We found this trial at
1
site
1120 15th Street
Augusta, Georgia 30909
Augusta, Georgia 30909
Principal Investigator: Norman K Pollock, Ph.D.
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