From Medscape Medical News
Vitamin D Deficiency Safely Corrected in Dialysis Patients
Kate Johnson
May 17, 2011 (Las Vegas, Nevada) — Low levels of 25-hydroxy (25-OH) vitamin D in patients on kidney dialysis can be safely corrected with oral cholecalciferol (vitamin D3), with no changes in serum calcium or parathyroid hormone levels, according to a study presented here at the National Kidney Foundation 2011 Clinical Meetings.
The study consisted of 95 patients (median age, 60 years), 57% of whom were male and 58% of whom were black. Subjects had been on dialysis for a median of 4 years and had a median body mass index (BMI) of 29 kg/m2. In addition, 46% had a diagnosis of diabetes and 41% were either former or current smokers.
There was a 91% prevalence of vitamin D insufficiency at baseline in the cohort, defined as a 25-OH vitamin D level below 30 ng/mL. Of these, 24.5% were categorized as deficient (25-OH vitamin D level below 10 ng/mL). The baseline median 25-OH vitamin D level of the cohort was 14.7 ng/mL.
"Our prevalence of vitamin D deficiency was a little bit higher than what's been reported in most of the literature, which may be related to the time of year," said investigator Anita Mehrotra, MD, from the division of nephrology, Department of Medicine, Mount Sinai School of Medicine, New York City.
We started recruiting in August; we didn't recruit in the peak summer months, when vitamin D levels might have been higher, she noted.
The researchers found no association between vitamin D level and age, sex, or years on dialysis. However, as expected, vitamin D levels were negatively correlated with BMI. Surprisingly, there was no correlation between vitamin D levels and race, said Dr. Mehrotra.
"Most previously published literature has found a correlation between vitamin D deficiency and race — showing that it's higher in African Americans than Caucasians because melanin in the skin blocks ultraviolet rays," she said.
"One explanation for our finding may be nutritional. The hemodialysis diet has to be low in phosphorous, so it's low in dairy products. Most vitamin D from food comes from dairy products that are fortified with vitamin D," Dr. Mehrotra explained.
Although the US Food and Drug Administration (FDA) recommends a nutritional vitamin D intake of 400 IU a day (2800 IU a week), dietary surveys conducted in a subset of patients on dialysis revealed their median weekly vitamin D consumption to be 1051 IU per week — less than half of what the FDA recommends, she said.
The study randomized all subjects with 25-OH vitamin D levels below 25 ng/mL to either standard care with 25-OH vitamin D supplementation (control group; n = 28) or treatment with cholecalciferol (n = 53) at a dose of 50,000 IU weekly for 6 weeks, followed by 10,000 IU weekly. The researchers measured 25-OH vitamin D levels after 6 weeks, and then at 3 and 6 months.
After 6 weeks of treatment, the control group showed no change in 25-OH vitamin D levels from baseline; the cholecalciferol group went from a median of 13.2 ng/mL to a median of 40.5 ng/mL 25-OH vitamin D (P < .0001).
At 3 and 6 months, the cholecalciferol group showed continued improvement (44.5 and 39.85 ng/mL, respectively), with no changes in serum calcium or parathyroid hormone levels. There was still no improvement in the control group.
The findings are noteworthy, in that they demonstrate both the safety and efficacy of cholecalciferol treatment, said Holly Kramer, MD, associate professor and kidney disease specialist at Loyola University Medical Center in Maywood, Illinois.
"In my experience, this issue is like a big black box; we treat everyone, we all use different treatments and protocols, and there are very few data on the outcome. What people are most concerned about is the serum calcium. That this study was able to show adequate repletion within 6 weeks without changing the serum calcium is very informative."
Dr. Mehrotra and Dr. Kramer have disclosed no relevant financial relationships.
National Kidney Foundation (NKF) 2011 Clinical Meetings: Abstract 205. Presented April 27, 2011.
http://www.medscape.com/viewarticle/742835