UnknownNot Applicable

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

United States30 participantsStarted 2016-10

Plain-language summary

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).

Who can participate

Age range8 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in serum lipid concentrations

Timeframe: 8 weeks

Change in insulin sensitivity

Timeframe: 8 weeks

Change in beta-cell function

Timeframe: 8-weeks

Trial details

NCT IDNCT02959762

SponsorAugusta University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12-01