Vitamin K to Slow Progression of Dyslipidemia and Diabetes Risk (Vita-K 'n' Kids Study II)
| Status: | Recruiting |
|---|---|
| Conditions: | Food Studies, High Cholesterol, Obesity Weight Loss, Peripheral Vascular Disease, Endocrine, Endocrine, Diabetes, Diabetes |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology, Pharmacology / Toxicology |
| Healthy: | No |
| Age Range: | 8 - 17 |
| Updated: | 7/14/2018 |
| Start Date: | October 2016 |
| End Date: | December 30, 2018 |
| Contact: | Norman K Pollock, PhD |
| Email: | npollock@augusta.edu |
| Phone: | 706-721-5424 |
Vitamin K to Slow Progression of Dyslipidemia and Diabetes Risk
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).
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).
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
We found this trial at
1
site
1120 15th Street
Augusta, Georgia 30909
Augusta, Georgia 30909
Phone: 706-721-5424
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