Background: There is high prevalence of vitamin-D deficiency and abnormal bone mineral density (BMD) in HIV patients. Our aim is to find out the effect of replacement of low dose oral vitamin-D (800 International unit) with calcium (500mg) as a once daily regimen along with antiretroviral (ARV) on serum vitamin-D and parathyroid hormone (PTH) level and bone mineral density (BMD) changes on patients with HIV infection who have vitamin- D deficiency. Methods: This is a non-randomised, open label study. We collected information about demography, viral load, CD-4 count, fracture risk factors. We measured serum 25(OH)D, parathyroid hormone (intact PTH), inorganic phosphate, corrected calcium, alkaline phosphatase (ALP) and BMD of hip and spine at baseline and after 12 months of routine follow up. Patients were treatment experienced and were divided into tenofovir containing, efavirenz containing, and protease Inhibitor (PI) containing regimens. Results: The study included 87 treatment experienced HIV patients with mean age 42.8 (+/-7.8) years, 55 (63%) females, 73 (84%) black African ethnicity, CD4 count 451.7 (+/-184.6) cells/dL, plasma VL 1.6 log (+/-0.03) copies/mL, exposure to antiretroviral therapy 43.2 (+/-30.2) months and duration of illness 58.4 (+/- 24.1) months. Forty four patients agreed to take vitamin-D with calcium replacement and 43 patients did not agree to take the replacement. After 12 months of follow up patients on vitamin D and calcium replacement (n=44) had significant increase in vitamin-D level (15.4+/-6.2 vs. 55.9+/-22.6, p=0.0001), reduction in PTH (8.04 +/-7.5, vs. 4.7 +/-1.8, p=0.005), alkaline phosphatase (111.1 +/-79.1 vs. 90.2+/-42.2, p=0.038) and increase in corrected calcium (2.18 +/-0.09 vs. 2.19 +/-0.09 p=0.001). In patients not on vitamin-D replacement (n=43), there was increase in vitamin-D (16.9 +/-12.1 vs. 49.4 +/-29.2, p=0.001) and corrected calcium (2.12 +/-0.09 vs. 2.16 +/-0.08 p=0.0001) level, but PTH and ALP did not change. BMD of hip and spine did not show any significant change in either of the two groups. In multivariate analysis that included all significant variables, vitamin-D and calcium replacement independently was associated with increase in vitamin-D level (OR 1.07, CI 1.02, 1.12, p=0.005), decrease in PTH level (OR 0.53, CI 0.35, 0.82, p=0.004), but not with change in corrected calcium, alkaline phosphatase, BMD of hip or spine. Conclusion: After 12 months of follow up, replacement of low dose once daily oral vitamin-D with calcium in treatment experienced HIV patients with vitamin-D deficiency can increase vitamin-D level, reduce PTH level without any change in BMD of hip and spine. Publisher statement: The published manuscript is available at EurekaSelect via http://www.eurekaselect.com/openurl/content.php?genre=article&doi=10.2174/1574891X11666160201122236.
|Journal||Recent Patents on Anti-Infective Drug Discovery|
|Publication status||Published - 2016|
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The published manuscript is available at EurekaSelect via http://www.eurekaselect.com/openurl/content.php?genre=article&doi=10.2174/1574891X11666160201122236.