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136


Safety of Calcium and Vitamin D Supplements, a Randomized Controlled Trial

Aloia, John F; Katumuluwa, Subhashini; Stolberg, Alexandra; Usera, Gianina; Mikhail, Mageda; Hoofnagle, Andrew N; Islam, Shahidul
OBJECTIVE:It is anticipated that an intake of vitamin D found acceptable by Endocrine Society Guidelines (10,000 IU/day) with co-administered calcium supplements may result in frequent hypercalciuria and hypercalcemia. This combination may be associated with kidney stones. The objective of this study was to compare the episodes of hypercalciuria and hypercalcemia from calcium supplements co-administered with 10,000 IU or 600 IU vitamin D daily. This design allows a comparison of the Institute of Medicine recommendation for the RDA of vitamin D along with the Upper Limit of calcium intake with the high intake of vitamin D suggested by the Endocrine Society. CONTEXT/BACKGROUND:Harms of currently recommended high intake of vitamin D have not been studied. DESIGN/METHODS:. PATIENTS/METHODS:This study was conducted in an ambulatory research center in healthy, white postmenopausal women. MEASUREMENTS/METHODS:Serum and 24-hour urine calcium were measured. RESULTS:Hypercalcemia and hypercalciuria occurred in both groups. At the final visit, 19/48 in the high dose D group had hypercalciuria. The odds of developing hypercalciuria was 3.6 [OR=3.6(1.39, 9.3)] times higher in the high dose D group. The odds of developing hypercalcemia did not differ between groups. CONCLUSIONS:The safe upper level of vitamin D recommended by the Endocrine Society when accompanied by calcium supplements results in frequent hypercalciuria. The risk of kidney stones at these levels should be investigated.
PMID: 30180273
ISSN: 1365-2265
CID: 3271212

Vitamin D Supplementation in Elderly Black Women Does Not Prevent Bone Loss: A Randomized Controlled Trial

Aloia, John; Fazzari, Melissa; Islam, Shahidul; Mikhail, Mageda; Shieh, Albert; Katumuluwa, Subhashini; Dhaliwal, Ruban; Stolberg, Alexandra; Usera, Gianina; Ragolia, Louis
Black Americans have lower levels of serum 25(OH)D but superior bone health compared to white Americans. There is controversy over whether they should be screened for vitamin D deficiency and have higher vitamin D requirements than recommended by the Institute of Medicine (IOM). The purpose of this trial was to determine whether Vitamin D supplementation in elderly black women prevents bone loss. A total of 260 healthy black American women, 60 years of age and older were recruited to take part in a two-arm, double-dummy 3-year randomized controlled trial (RCT) of vitamin D3 versus placebo. The study was conducted in an ambulatory clinical research center. Vitamin D3 dose was adjusted to maintain serum 25(OH)D above 75 nmol/L. Bone mineral density (BMD) and serum were measured for parathyroid hormone (PTH), C-terminal crosslink telopeptide (CTX), and bone-specific alkaline phosphatase (BSAP) every 6 months. Baseline serum 25(OH)D3 was 54.8 ± 16.8 nmol/L. There was no group × time interaction effect for any BMD measurement. For all BMD measurements, except for total body and spine, there was a statistically significant negative effect of time (p < 0.001). An equivalency analysis showed that the treatment group was equivalent to the control group. Serum PTH and BSAP declined, with a greater decline of PTH in the treatment group. The rate of bone loss with serum 25(OH)D above 75 nmol/L is comparable to the rate of loss with serum 25(OH)D at the Recommended Dietary Allowance (RDA) of 50 nmol/L. Black Americans should have the same exposure to vitamin D as white Americans. © 2018 American Society for Bone and Mineral Research.
PMID: 29905969
ISSN: 1523-4681
CID: 3537322

A Quality Improvement Intervention to Decrease Hypothermia in the Delivery Room Using a Checklist

Vinci, Alexandra; Islam, Shahidul; Quintos-Alegheband, Lyn; Hanna, Nazeeh; Nayak, Amrita
Introduction/UNASSIGNED:Premature babies are at increased risk of hypothermia, core body temperature <97°F. Delivery room environment may contribute and lead to complications. The objective was to reduce hypothermia in babies <32 weeks of gestation in the delivery room to <40% using a checklist and sustain it for 6 months. Methods/UNASSIGNED:We created a delivery room checklist in 2012. Chart review established a baseline rate of hypothermia (<97°F). The team analyzed the checklist's effect on hypothermia from 2012 to 2018 and utilized numerous interventions to maintain compliance. Chi-square test and Fisher's exact test analyzed hypothermia and hyperthermia as a balancing measure. All calculations performed in SAS 9.3. Results/UNASSIGNED:The checklist reduced hypothermia from a baseline of 50% in 2011 (n = 104) to 33% in 2012 (n = 106). In 2013, the proportion of hypothermia slightly increased to 36% (n = 81). The year 2014 brought larger drift, and proportion of hypothermia increased to 44% (n = 117). In 2015, we reinforced the use of the checklist and proportion of hypothermia improved to 36% (n = 99). Further interventions through 2018 decreased hypothermia further to 14% to achieve statistical significance. Conclusions/UNASSIGNED:A checklist is a simple tool that may yield beneficial changes in practice and helped to decrease the proportion of neonatal hypothermia.
PMCID:6581478
PMID: 31334457
ISSN: 2472-0054
CID: 4014912

Utilization rates of enoxaparin and heparin in deep venous thrombosis prophylaxis after education and electronic order change at a single institution: a quality improvement study

Hoang, Linda; Islam, Shahidul; Hindenburg, Alexander
Despite advantages of low molecular weight heparin (LMWH), enoxaparin over heparin (UFH) for venous thromboembolism (VTE), a hospital's prescribing trends analysis showed use of each was about equal. In an attempt to increase LMWH over UFH use, electronic medical record (EMR) changes for medical service patients and education via multidisciplinary grand rounds was provided to all services. This was a unique opportunity to study LMWH and UFH use pre and post interventions at our institution. Citrix Pharmacy data was extracted for 3 months pre and post intervention (August 2016-February 2017). Inclusion criteria were age > 18 and LMWH or UFH VTE prophylaxis. Exclusion criteria were one time or duplicate orders and VTE treatment doses. Primary endpoint was hospital services VTE use with focus on medicine service which had both interventions compared to single intervention among all other services. LMWH use increased from 51 to 57.3% (p < 0.001) and UFH use decreased from 49 to 42.7% (p < 0.001) for all services. For medicine service, LMWH use increased 52.5-59.6% (p < 0.001) and UFH use decreased 47.5-40.4% (p < 0.001). For other services, LMWH use increased 48.8-53.6% (p = 0.005) and UFH use decreased 51.2-46.4% (p = 0.005). EMR changes and prescribers' grand rounds education resulted in 7.1% increase of LMWH use for medicine and 4.8% increase for all other services. The net increase (95% CI) in LMWH use in medicine service is 2.3% (- 1.91%, 6.56%) compared to the other services p = 0.281. Future studies are needed to reassess the effects of continued education and outcome of interventions.
PMID: 30136019
ISSN: 1573-742x
CID: 5034332

Association of Antibiotic and Proton Pump Inhibitor Usage in Patients with Hospital Acquired Clostridium difficile Infection: A Single Center Experience [Meeting Abstract]

Ballecer, Eric; Ali, Mohammad; Patel, Zinal; Shen, Mark; Islam, Shahidul; Vrabie, Raluca; Grendell, James H.
ISI:000464611002222
ISSN: 0002-9270
CID: 3897692

Short-Term Effects of Cold Liquids on the Pharyngeal Swallow in Preterm Infants with Dysphagia: A Pilot Study

Ferrara, Louisa; Kamity, Ranjith; Islam, Shahidul; Sher, Irene; Barlev, Dan; Wennerholm, Laurie; Redstone, Fran; Hanna, Nazeeh
Cold stimulation reduces airway compromise in adults with dysphagia. However, there is no sufficient evidence to support its use in the pediatric population. The primary goal of this pilot study is to assess the effect of cold liquid on the pharyngeal swallow mechanism in preterm infants with dysphagia. We hypothesized that thermal stimulation from cold liquid will decrease the risk of airway compromise in dysphagic preterm infants. Nine preterm infants with clinical symptoms of dysphagia were included. Video fluoroscopic swallow studies were used to assess the swallowing mechanism of each participant. The occurrence of swallow dysfunctions under room temperature liquid swallows (RTS) vs. short period cold liquid swallows (CS) was compared. Paired t test was used to test significance. The occurrence of deep penetration (p = 0.007) and aspiration (p = 0.002) decreased significantly in the CS condition compared with the RTS condition. There was a trend of less nasopharyngeal reflux with CS but did not reach statistical significance (p = 0.084). No differences were noted for mild penetration (p = 0.824). CS reduced airway compromise in dysphagic preterm infants compared to RTS. These data provide important information regarding the immediate effects of CS on pharyngeal swallowing in preterm infants with dysphagia. However, further investigation regarding its sustained effects is required before introducing to clinical practice.
PMID: 29435661
ISSN: 1432-0460
CID: 3004442

Mechanisms of Lead Failure by Recall Status and Manufacturer: Results From the Pacemaker and Implantable Defibrillator Leads Survival Study ("PAIDLESS")

Schwarzwald, Sam N; Kersten, Daniel J; Shaikh, Zohaib A; Needelman, Brandon S; Feldman, Alyssa M; Germano, Joseph; Islam, Shahidul; Cohen, Todd J
OBJECTIVES/OBJECTIVE:The aim of this study was to determine the differences in lead failure mechanisms across the major United States implantable defibrillator lead manufacturers (Boston Scientific, Medtronic, and St. Jude Medical), between all non-recalled and recalled leads, and between two recalled lead families (Medtronic Sprint Fidelis and the St. Jude Medical Riata and Riata ST). METHODS:This was a single-center, non-randomized, retrospective study analyzing 3802 patients with 4078 leads who underwent implantable defibrillator lead implantation between February 1, 1996 and December 31, 2011. Lead failure mechanisms were defined as lead fracture, insulation defect, and other. RESULTS:A total of 153 leads (3.8%) failed during the trial period. Failed Medtronic and St. Jude Medical leads presented predominantly as lead fractures (75.8% and 52.8%, respectively). Failed Boston Scientific leads displayed greater variability, although many also failed by fracture (44.4%). The majority of failed non-recalled and recalled leads presented as fractures (50.7% and 82.9%, respectively). The recalled Medtronic Sprint Fidelis and St. Jude Medical Riata/Riata ST leads primarily presented as fractures (89.3% and 65.0%, respectively). Patients whose lead failed via an insulation defect or other mechanism appeared to have a faster time to mortality following lead failure than patients whose lead failed via fracture (P<.01 and P=.02, respectively). CONCLUSIONS:Lead fracture is the most common form of lead failure regardless of the failure points previously identified in these leads. Patients who experienced a lead failure as a result of an insulation defect or other mechanism appeared to die faster than patients whose lead failed via fracture.
PMID: 29610446
ISSN: 1557-2501
CID: 3482362

PERCUTANEOUS CORONARY INTERVENTION IS SAFE PRIOR TRANSCATHETER AORTIC VALVE REPLACEMENT [Meeting Abstract]

Elyasi, Maekal; Rambhujun, Vikashsingh P.; Medranda, Giorgio A.; Sapia, Paul J.; Islam, Shahidul; Green, Stephen
ISI:000429659702578
ISSN: 0735-1097
CID: 3485492

The relationship of Physical performance and Osteoporosis prevention with vitamin D in older African Americans (PODA)

Dhaliwal, Ruban; Mikhail, Mageda; Usera, Gianina; Stolberg, Alexandra; Islam, Shahidul; Ragolia, Louis; Aloia, John F
RATIONALE/BACKGROUND:Vitamin D deficiency is associated with bone loss, poor muscle strength, falls and fracture. This information in older African Americans (AAs) is sparse. OBJECTIVE:The study of the relationship of Physical performance, Osteoporosis prevention with vitamin D in older African Americans (PODA) is a randomized, double-blind, placebo-controlled 3-year trial examining the effect of vitamin D on bone loss and physical performance in older AA women. METHODS:dose was determined by the baseline serum 25OHD level, and adjusted further to maintain serum 25OHD between 30 and 69ng/ml. Subjects with baseline 25OHD levels ≤8ng/ml or ≥26ng/ml were excluded. Objective measures of neuromuscular strength [Short Physical Performance Battery (SPPB), grip strength and 6-minute walking distance (6MWD)] and bone mineral density (BMD) were obtained. RESULTS:SPPB gait speed, grip strength and 6MWD showed a significant positive correlation with free 25OHD. 1pg/ml increase in free 25OHD predicted a 32% increase in the odds of having higher gait speed and a 1.42lb. increase in grip strength. No significant differences in BMI, BMD, muscle mass, grip strength, serum total 25OHD and free 25OHD were observed between groups. None of the measures of physical performance showed an association with baseline serum 25OHD. CONCLUSIONS:This is the first study to show an association between free 25OHD and physical performance. These findings indicate a positive relationship of free 25OHD with gait speed and grip strength in older AA women. Further studies are needed to understand the role of free 25OHD.
PMCID:5803298
PMID: 29221945
ISSN: 1559-2030
CID: 2986682

PSA kinetics following primary focal cryotherapy (hemiablation) in organ-confined prostate cancer patients

Kongnyuy, Michael; Islam, Shahidul; Mbah, Alfred K; Halpern, Daniel M; Werneburg, Glenn T; Kosinski, Kaitlin E; Chen, Connie; Habibian, David J; Schiff, Jeffrey T; Corcoran, Anthony T; Katz, Aaron E
PURPOSE/OBJECTIVE:We aim to evaluate prostate-specific antigen (PSA) trends in post-primary focal cryotherapy (PFC) patients. MATERIALS AND METHODS/METHODS:This was an institutional review board-approved retrospective study of PFC patients from 2010 to 2015. Patients with at least one post-PFC PSA were included in the study. Biochemical recurrence (BCR) was determined using the Phoenix criteria. PSA bounce was also assessed. We analyzed rates of change of PSA over time of post-PFC between BCR and no BCR groups. PSA-derived variables were analyzed as potential predictors of BCR. RESULTS:A total of 104 PFC patients were included in our analysis. Median (range) age and follow-up time were 66 (48-82) years and 19 (6.3-38.6) months, respectively. Four (3.8%) patients experienced PSA bounce. The median percent drop in first post-PFC PSA of 80.0% was not associated with BCR (p = 0.256) and may indicate elimination of the index lesion. The rate of increase of PSA in BCR patients was significantly higher compared to patients who did not recur (median PSA velocity (PSAV): 0.15 vs 0.04 ng/ml/month, p = 0.001). Similar to PSAV (HR 9.570, 95% CI 3.725-24.592, p < 0.0001), PSA nadir ≥ 2 ng/ml [HR (hazard ratio) 1.251, 95% CI 1.100-1.422, p = 0.001] was independently associated with BCR. CONCLUSION/CONCLUSIONS:A significant drop in post-PFC PSA may indicate elimination of the index lesion. Patients who are likely to recur biochemically have a significantly higher PSAV compared to those who do not recur. Nadir PSA of less than 2 ng/ml may be considered the new normal PSA in focal cryotherapy (hemiablation) follow-up.
PMID: 29149380
ISSN: 1433-8726
CID: 3499112