Food intake restriction for health outcome support and education (firehouse): A randomized clinical trial [Meeting Abstract]
Young, I R; Lam, R; Kwon, S; Crowley, G; Riggs, J; Ostrofsky, D; Nayar, C; Zeig-Owens, R; Schwartz, T M; Colbeth, H L; Mikhail, M; Veerappan, A; Pompeii, M; St-Jules, D E; Liu, M; Prezant, D J; Sevick, M A; Nolan, A
RATIONALE Particulate matter (PM) exposure and Metabolic Syndrome (MetSyn) are growing, global health concerns. FDNY first responders experienced a high exposure to PM following the collapse of the WTC, due to their detailed phenotyping we were able to observe that MetSyn characteristics were associated with higher risk of developing WTC-lung injury [WTC-LI; forced expiratory volume in 1 second (FEV1) less than the lower limit of normal (LLN)]. Our prior metabolomics studies showed metabolites-polyunsaturated fatty acids and branched chain amino acids-rich in Mediterranean type diets were higher in subjects that didn't develop WTC-LI. Therefore, our objective was to investigate how a calorie-restricted Mediterranean dietary intervention could attenuate the adverse effects of WTC exposure among the affected FDNY population. METHODS Food Intake REstriction for Heath OUtcome Support and Education (FIREHOUSE) RCT is a calorie-restricted Mediterranean 6- month dietary intervention of male firefighters with WTC-LI and BMI>27kg/m2; ClinicalTrials.gov Identifier: NCT03581006, NYU IRB # 17-00127. Power analysis and primary outcome assessment targeted at least a 1 kg/m2 change of BMI (primary outcome) in the intervention group. Secondary outcomes include FEV1, fractional exhaled nitric oxide (FeNO), pulse wave velocity (PWV), lipid profiles, targeted metabolic/clinical biomarkers, and quality of life measures. Change in outcomes from baseline to 6-months post-intervention will be compared between the two randomized groups. Interim analysis with an O'Brien Fleming boundary for a 3-look design was planned at the completion 30, 50, and 70 subjects in each group with an alpha spending rule of 0.001, 0.007, and 0.033, respectively. Subjects were randomized 1:1 to Low Calorie Mediterranean (LoCalMed), integrative technology-supported approach with social cognitive theory-based group counseling or Usual care. RESULTS Our interim analysis showed that LowCalMed resulted in a significant reduction in BMI compared to usual care (n=40/arm) (p<0.001 via independent two sample t-test). While we are continuing to analyze our data, so far we observed a decreased BMI in both groups; however, the intervention has a mean BMI reduction of 1.84 kg/m2 while the controls' mean difference was only 0.61 kg/m2, Figure 1. CONCLUSIONS While this study focuses on a population with a unique exposure, exposure to PM is a grave issue with global implications. Additionally, MetSyn is an increasing problem throughout the world. The findings of this study aim to not only improve the quality of life and lung health of the WTC-exposed population, but also be generalized to benefit a broader global context
Effect of vitamin D on bone strength in older African Americans: a randomized controlled trial
Dhaliwal, R; Islam, S; Mikhail, M; Ragolia, L; Aloia, J F
There is controversy over whether African Americans have higher vitamin D requirements than recommended by the Institute of Medicine. We previously reported that maintaining serum 25(OH)D above 30Â ng/mL does not prevent age-related bone loss. Herein, we report that bone strength is also unaffected by maintaining this level in this population.
Vitamin D and Abdominal Aortic Calcification in Older African American Women, the PODA Clinical Trial
Brahmbhatt, Saloni; Mikhail, Mageda; Islam, Shahidul; Aloia, John F
Abdominal aortic calcification (AAC) detected on lateral vertebral fracture assessment is associated with increased cardiovascular risk. Vitamin D deficiency and toxicity have been linked with vascular calcification. The objective of this study was to determine the effect of high-dose vitamin D on the progression of AAC. The Physical Performance, Osteoporosis and vitamin D in African American Women (PODA) is a randomized, clinical trial examining the effect of vitamin D. There were 14.7% subjects with AAC in the vitamin D group, compared to 12.1% in the placebo group at baseline. The prevalence of extended AAC at baseline was 6.4% in the vitamin D group and 3.5% in the placebo group. The extended calcification scores over time were not different between groups. There was no association between AAC and serum 25(OH)D. However, PTH was associated with an increase in AAC in the placebo group.
METABOLIC SYNDROME BIOMARKERS OF WORLD TRADE CENTER AIRWAY HYPERREACTIVITY: A 16-YEAR PROSPECTIVE COHORT STUDY [Meeting Abstract]
Kwon, S; Crowley, G; Mikhail, M; Lam, R; Clementi, E; Zeig-Owens, R; Schwartz, T; Liu, M; Prezant, D; Nolan, A
SESSION TITLE: Population-Wide Lung Health: Exposures and Risks SESSION TYPE: Original Investigations PRESENTED ON: 10/23/2019 10:45
Vitamin D and Acute Respiratory Infections-The PODA Trial
Aloia, John F; Islam, Shahidul; Mikhail, Mageda
Background/UNASSIGNED:There is considerable heterogeneity in clinical trials examining the role of vitamin D in the prevention of acute respiratory infections (ARIs). Methods/UNASSIGNED:The primary aim of the Physical Performance, Osteoporosis, and Vitamin D in Older African-American Women (PODA) trial was the prevention of bone loss and decline in physical performance. A questionnaire about ARIs was administered every 3 months for 3 years to 260 black American women in a double-blind randomized clinical trial that had a placebo group and a vitamin D supplementation group. The serum 25(OH)D level was maintained >30 ng/mL in the vitamin D group. Results/UNASSIGNED:Serum 25(OH)D was maintained >30 ng/mL in 90% of the active group, whereas levels approximated those associated with the recommended dietary allowance (20 ng/mL) in the placebo group. There was no difference in occurrence of ARIs in the treatment group vs the placebo group. ARIs were not related to total or free 25(OH)D, which were measured at baseline and annually for 36 months. Conclusions/UNASSIGNED:Vitamin D supplementation sufficient to maintain serum 25(OH)D >30 ng/mL does not prevent ARIs in older African American women. ClinicalTrialsgov Registration Number/UNASSIGNED:NCT01153568.
Physical Performance and Vitamin D in Elderly Black Women - The PODA Randomized Clinical Trial
Aloia, John; Mikhail, Mageda; Fazzari, Melissa; Islam, Shahidul; Ragolia, Lou; Guralnik, Jack
Context/UNASSIGNED:There is limited information on the influence of vitamin D on physical performance in black Americans. Objective/UNASSIGNED:To determine if maintenance of serum 25(OH)D above 75 nmol/L prevents the decline in physical performance. Design/UNASSIGNED:The PODA trial had a prospective, randomized, placebo controlled, double-dummy design with two arms: one with placebo vitamin D3 adjusted to maintain serum 25(OH)D above 75 nmol/L. Patients/UNASSIGNED:The target population was healthy elderly black women with serum 25(OH)D between 20 and 65 nmol/L. The trial was 3 years in duration with measurement of physical performance every 6-months: Grip strength, Short Physical Performance Battery (SPPB), 10 chair rises and 6-minute walk distance. 260 women entered the study and 184 completed 3 years. Mean age was 68.2 years. Baseline 25(OH)D was 53 nmol/L and total SPPB was 11 (10-12). Setting/UNASSIGNED:Research Center in an Academic Health Center. Main Outcomes Measure/UNASSIGNED:Prevention of decline in physical performance measures. Intervention/UNASSIGNED:Participants were randomly assigned to placebo or active vitamin D. Vitamin D3 dose was adjusted to maintain serum 25(OH)D above 75 nmol/l. Results/UNASSIGNED:There was a decline with time in grip strength and the 6-minute walk. The SPBB increased with time. There were no significant differences between the placebo and active vitamin D3 groups with respect to the temporal patterns observed for any of the performance measures. Conclusions/UNASSIGNED:There is no benefit of maintaining serum 25(OH)D above 75 nmol/L in preventing the decline in physical performance in healthy black American women.
Vitamin D and Falls in Older African American Women: The PODA Randomized Clinical Trial
Aloia, John F; Rubinova, Rakhil; Fazzari, Melissa; Islam, Shahidul; Mikhail, Mageda; Ragolia, Louis
BACKGROUND:Limited information is available on the influence of vitamin D on falls in older high-functioning black American women. Endocrine Society guidelines propose serum 25(OH)D levels over 30 ng/mL. OBJECTIVE:To determine if maintenance of serum 25(OH)D above 30 ng/mL protects against falls. DESIGN/METHODS:adjusted to maintain serum 25(OH)D above 30 ng/mL. The primary outcomes were the prevention of bone loss and the decline in physical performance. PATIENTS/METHODS:The target population was healthy black women older than 60 years with serum 25(OH)D between 8 and 26 ng/mL. The trial was 3 years in duration with a falls questionnaire administered every 3 months. A total of 260 women entered the study, and 184 completed the 3 years. Mean age was 68.2 years. SETTING/METHODS:Research center in an academic health center. MAIN OUTCOMES MEASURE/METHODS:Prevention of falls. INTERVENTION/METHODS:dose was adjusted to maintain serum 25(OH)D above 30 ng/mL in the active group using a double-dummy design. RESULTS:Baseline 25(OH)D was 22 ng/mL. Mean serum 25(OH)D reached 47 ng/mL in the active group compared with 21 ng/mL in the placebo group. There were 14.2% falls in the previous year recalled at baseline. During the study, 46% reported falling in the treatment group compared with 47% in the placebo group. There was no association of serum 25(OH)D or vitamin D dose with the risk of falling. CONCLUSIONS:There is no benefit of maintaining serum 25(OH)D above 30 ng/mL compared with the Institute of Medicine recommendation (20 ng/mL) in preventing falls in healthy older black American women.
Receptor for Advanced Glycation End-Products and Environmental Exposure Related Obstructive Airways Disease: A Systematic Review [Meeting Abstract]
Oskuei, A.; Haider, S. H.; Crowley, G.; Kwon, S.; Lam, R.; Riggs, J.; Mikhail, M.; Talusan, A.; Kim, J.; Caraher, E.; Veerappan, A.; Nolan, A.
Quantifying Cardiopulmonary Collagen Deposition in a Murine Model of WTC-PM Exposure [Meeting Abstract]
Mikhail, M.; Crowley, G.; Veerappan, A.; Haider, S.; Caraher, E.; Lam, R.; Kwon, S.; Ostrofsky, D.; Nolan, A.
Validation of Biomarkers of World Trade Center (WTC) Lung Injury: Design of a Case Cohort Control [Meeting Abstract]
Riggs, J.; Kwon, S.; Crowley, G.; Ostrofsky, D.; Talusan, A.; Mikhail, M.; Kim, J.; Zeig-Owens, R.; Schwartz, T.; Prezant, D. J.; Liu, M.; Nolan, A.