HEALTH

Study: Vitamin D deficiency may lead to arterial stiffness in black teens

BY Michael Johnsen

CHEVY CHASE, Md. Vitamin D deficiency is associated with arterial stiffness, a risk factor for heart disease and stroke in African-American teens, according to a new study accepted for publication on The Endocrine Society’s website, Endo-society.org.

“While we think of the sun as providing humans with most of our body’s requirement of vitamin D, 95% of the 44 black teenagers living in sunny Georgia who took part in this study were classified as vitamin D deficient,” stated Yanbin Dong, lead author of the study. “Our study shows that vitamin D supplementation may improve cardiovascular health in black teens who don’t get enough vitamin D from their diet and sun exposure.”

In this study, 44 black teenagers (male and female) were randomly assigned to receive either 400 IU of vitamin D per day as recommended by the American Academy of Pediatrics or 2,000 IU of vitamin D per day. Study subjects taking 400 IU of vitamin D per day did not achieve vitamin D sufficiency, while their peers who took 2,000 IU of vitamin D per day on average became vitamin D sufficient.

Black teens taking vitamin D supplementation of 2,000 international units (IU) per day had a decrease in central arterial stiffness.

“Our study is the first clinical trial of vitamin D intervention to use 2,000 IU in black subjects and to include cardiovascular risk factors as outcomes in youth,” Dong said. “Our study indicates that the current recommendations for vitamin D intake in black teenagers may need to be revised upward.”

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Bayer Diabetes Care updates devices under National Glycohemoglobin Standardization Program

BY Michael Johnsen

TARRYTOWN, N.Y. Bayer Diabetes Care has successfully completed certification of its A1CNow+ and A1CNow Selfcheck devices under a tighter performance certification standard that went into effect Jan. 1.

The new performance certification standards applicable to devices that measure A1C (or glycated hemoglobin) as set by the National Glycohemoglobin Standardization Program (NGSP) changed to +/-0.75% A1C, 95% CI, 4-10.0% A1C range.

Bayer received a new NGSP certificate valid from July 1, 2010 through July 1, 2011.  The previous criteria for last year’s NGSP certification was +/-0.85% A1C, 95% CI, 4-12.0% A1C range.

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FDA issues warning letter to Abbott Diabetes Care manufacturing plant

BY Michael Johnsen

ROCKVILLE, Md. The Food and Drug Administration earlier this week posted a July 2 warning letter addressing quality concerns at an Abbott Diabetes Care manufacturing plant.

The warning letter outlined some of the specific violations of good manufacturing practices for the manufacturer of the FreeStyle blood glucose meter, including not following through on reports concerning empty blister packs being produced on the Noack Blister Packer at one of Abbott’s establishments. Similarly, an exception report initiated on April 8, 2008, for scratches on FreeStyle Lite strips was closed with no corrective action or effectiveness check, the agency stated.

Abbott is working with the FDA to address the agency’s concerns.

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