Ageism webinars: a needs-based continuing education training for the national aging network.

To combat ageism, the National Resource Center on Nutrition and Aging (NRCNA) launched two Ageism Webinars (AWs). The study's aims were to 1) assess the effectiveness of the AWs for increasing participants' perceived familiarity (FAM) and knowledge (KNOW) and producing high behavioral intent to implement recommended action steps and quality among participants, and 2) practice equitable evaluation by ascertaining whether outcomes were fairly achieved by participants regardless of race, age, and education. A convenience sample of mostly educated non-Hispanic females with an average age of 52 years (n = 193) completed a retrospective online survey post-webinar. A retrospective Likert scale noted an overall increase in perceived FAM and KNOW (p < 0.001). However, these changes were significantly smaller (p < 0.05) among those from historically marginalized races and ethnicities. The theory of planned behavior (TPB) items predicted high intention to complete the recommended action step following the webinars. High satisfaction for webinars was reported, with 98.7% wanting to attend future NRCNA training. This study provides evidence of an effective training modality for addressing ageist perspectives, and the demonstrated differences provide insight into how to improve the AWs and the evaluation of future webinars.

Role of dietary patterns and acculturation in cancer risk and mortality among postmenopausal Hispanic women: results from the Women's Health Initiative (WHI).

Aim: To investigate the association between dietary patterns and total and obesity-related cancers risk. Additionally, to examine if acculturation modifies this relationship. Subject and Methods: Dietary intake of postmenopausal Hispanic women (N=5,482) enrolled in the Women's Health Initiative was estimated from a Food Frequency Questionnaire and used to calculate dietary pattern scores; Healthy Eating Index-2015 (HEI-2015), Mexican Diet (MexD) score, alternate Mediterranean Diet Score (aMED), and the energy adjusted-Dietary Inflammatory Index (E-DII™). Associations were evaluated using Cox proportional hazards regression models. Results: 631 cancers and 396 obesity-related cancers were diagnosed over a mean-follow up of 12 years. Across dietary scores, there were no significant associations with cancer risk or mortality. Trend analysis suggest a potentially lower risk for total cancer related to the highest MexD score (HR 0.68, 95% CI 0.45-1.04, P-trend=0.03), and lower risk for obesity-related cancer mortality related to the highest score category for MexD (HR 0.65, 95% CI 0.37-1.16, P-trend=0.02), and aMED (HR 0.87, 95% CI 0.45-1.67, P-trend=0.04). Further analysis suggests less acculturated women with higher MexD scores had 56% lower risk for any cancer (HR 0.44, 95% CI 0.22-0.88, P-trend=0.03) and 83% lower risk for cancer mortality (HR 0.17, 95% CI 0.04-0.76, P-trend=0.01) compared to more acculturated Hispanic women. Conclusions: Dietary patterns were not associated with cancer risk and mortality in postmenopausal Hispanic women. Less-acculturated, Spanish-preferred speakers, who reported consuming a more traditional Mexican diet may experience a lower risk for cancer and cancer mortality.

Dietary Intakes of Women's Health Initiative Long Life Study Participants Falls Short of the Dietary Reference Intakes.

BACKGROUND: Understanding how nutrient intake in older women compares with recommendations is important. The Academy of Nutrition and Dietetics position statement summarizes the nutrient needs of older adults (aged ≥60 years) based on a systematic review. OBJECTIVE: The objective of this study was to compare nutrient intake of Women's Health Initiative Long Life Study participants to the Dietary Reference Intakes for nutrients reviewed in the Academy of Nutrition and Dietetics position statement. DESIGN: The study is a cross-sectional analysis. PARTICIPANTS/SETTING: Participants (n=7,875) were mailed the General Nutrition Assessment Food Frequency Questionnaire during 2012-2013, of whom 77% (n=6,095) completed it, and 5,732 were included in the analytic sample after exclusion for implausible energy intakes. MAIN OUTCOME MEASURES: Mean intake of energy and protein, calcium, fiber, folate, potassium, sodium, vitamins B-12, D, E, and K were described overall and compared with recommendations. STATISTICAL ANALYSES PERFORMED: Demographic and lifestyle characteristics were summarized using descriptive statistics. The proportion of participants meeting recommendations was computed. RESULTS: Mean age of completers was 79±7 years and 53.5% were non-Hispanic white, 30% were non-Hispanic black, and 16.5% were Hispanic/Latina. Only one-third of women consumed ≥21 g/day fiber, whereas fewer met the Recommended Dietary Allowance for calcium (18.6%), vitamin E (16.9%), and vitamin D (1.7%). Just more than half (56%) of participants met the Recommended Dietary Allowance for protein of 0.8 g/kg body weight/day, and just less than half (47.0%) met potassium guidelines. CONCLUSIONS: These findings suggest older women within the Women's Health Initiative were generally not achieving recommended intake for several key nutrients highlighted by the Academy of Nutrition and Dietetics position statement. These findings underscore the need to identify effective approaches for improving the nutrient density of dietary intake in older women.

A Comparison of US and Canadian Osteoporosis Screening and Treatment Strategies in Postmenopausal Women.

The optimal approach to osteoporosis screening and treatment in postmenopausal women is unclear. We compared (i) the United States Preventive Services Task Force (USPSTF) and Osteoporosis Canada osteoporosis screening strategies; and (ii) the National Osteoporosis Foundation (NOF) and Canadian treatment strategies. We used data from the prospective Women's Health Initiative Observational Study and Clinical Trials of women aged 50 to 79 years at baseline (n = 117,707 followed for self-reported fractures; n = 8134 in bone mineral density [BMD] subset). We determined the yield of the screening and treatment strategies in identifying women who experienced major osteoporotic fractures (MOFs) during a 10-year follow-up. Among women aged 50 to 64 years, 23.1% of women were identified for BMD testing under the USPSTF strategy and 52.3% under the Canadian strategy. For women ≥65 years, 100% were identified for testing under the USPSTF and Canadian strategies, 35% to 74% were identified for treatment under NOF, and 16% to 37% were identified for treatment under CAROC (range among 5-year age subgroups). Among women who experienced MOF during follow-up, the USPSTF strategy identified 6.7% of women 50 to 54 years-old and 49.5% of women 60 to 64 years-old for BMD testing (versus 54.4% and 60.6% for the Canadian strategy, respectively). However, the specificity of the USPSTF strategy was higher than that of the Canadian strategy among women 50 to 64 years-old. Among women who experienced MOF during follow-up, sensitivity for identifying women as treatment candidates was lowest for both strategies in women aged 50 to 64 (NOF 10% to 38%; CAROC 1% to 15%) and maximal in 75-year-old to 79-year-old women (NOF 82.8%; 51.6% CAROC); specificity declined with advancing age and was lower with the NOF compared to the CAROC strategy. Among women aged 50 to 64 years, the screening and treatment strategies examined had low sensitivity for identifying those who subsequently experience MOF; sensitivity was higher among women ≥65 years than among younger women. New screening and treatment algorithms are needed. © 2018 American Society for Bone and Mineral Research.

Low-Fat Dietary Pattern and Cancer Mortality in the Women's Health Initiative (WHI) Randomized Controlled Trial.

BACKGROUND: In the Women's Health Initiative Dietary Modification trial, a low-fat dietary pattern reduced deaths after breast cancer. Mortality from other cancer sites has not been reported. METHODS: A low-fat dietary pattern influence on deaths from and after site-specific cancers was examined during 8.5 years (median) of dietary intervention and cumulatively during 17.7 years (median) of follow-up. A total 48 835 postmenopausal women, ages 50-79 years, were randomly assigned from 1993 to 1998 at 40 US clinical centers to dietary intervention (40%, n = 19 541 or a usual diet comparison group (60%, n = 29 294). Dietary intervention influence on mortality from protocol-specified cancers (breast, colon and rectum, endometrium and ovary), individually and as a composite, represented the primary analyses. RESULTS: During the dietary intervention period, a reduction in deaths after breast cancer (HR = 0.65 95% CI = 0.45 to 0.94, P = .02) was the only statistically significant cancer mortality finding. During intervention, the HRs for deaths after the protocol-specified cancer composite were 0.90 (95% CI = 0.73 to 1.10) and 0.95 (95% CI = 0.85 to 1.06) for deaths after all cancers. During 17.7 years of follow-up with 3867 deaths after all cancers, reduction in deaths after breast cancer continued in the dietary intervention group (HR = 0.85, 95% CI = 0.74 to 0.99, P = .03). However, no dietary intervention influence on deaths from or after any other cancer or cancer composite was seen. CONCLUSIONS: A low-fat dietary pattern reduced deaths after breast cancer. No reduction in mortality from or after any other cancer or cancer composite was seen.

A Randomized Double-Blind Placebo-Controlled Trial of Fruit and Vegetable Concentrates on Intermediate Biomarkers in Head and Neck Cancer.

BACKGROUND: Head and neck cancer (HNC) patients are at an increased risk for developing second primary tumors (SPTs). Diets rich in fruits and vegetables (FVs) may lower HNC risk. FV concentrates may offer a potential alternative to increasing FV intake. METHODS: We conducted a randomized, double-blind, placebo-controlled trial to evaluate whether Juice PLUS+ (JP; a commercial product with multiple FV concentrates) has an effect on p27 and Ki-67, biomarkers associated with the risk of SPTs. During 2004-2008, we randomized 134 HNC patients to 12 weeks of JP (n = 72) or placebo (n = 62). Oral cavity mucosal biopsies and whole blood were obtained at baseline and after 12 weeks. All participants were given the opportunity to receive JP for 5 years following the end of the intervention period, and they were followed yearly for the development of SPTs. RESULTS: After 12 weeks, patients on JP had significantly higher serum α-carotene ( P = .009), ß-carotene ( P < .0001), and lutein ( P = .003) but did not differ significantly in p27 ( P = .23) or Ki-67 ( P = .95). JP use following the initial 12-week trial was not significantly associated with SPT prevention. CONCLUSIONS: Despite increased serum micronutrient levels, our results do not suggest a clinical benefit of JP in HNC patients. Future studies should focus on longer intervention periods and/or modified supplement formulations with demonstrated chemopreventive properties.

Association between Dietary Energy Density and Obesity-Associated Cancer: Results from the Women's Health Initiative.

BACKGROUND: Dietary energy density (DED) is the ratio of energy (kilocalories or kilojoules) intake to food weight (grams) and is a measure of diet quality. Consumption of foods high in DED has been associated with weight gain in adults. OBJECTIVE: To investigate the association between baseline DED and incident obesity-associated cancers in the Women's Health Initiative. DESIGN: Prospective cohort study of clinical trial and observational study participants. PARTICIPANTS/SETTING: Postmenopausal women aged 50 to 79 years (N=92,295) enrolled in the observational study or the calcium and vitamin D trial and hormone replacement therapy trials of the Women's Health Initiative. MAIN OUTCOME MEASURES: Incident, medical record-adjudicated, obesity-related cancers during follow-up. Exposure variable was DED (kilocalories per gram for the total diet) from self-reported dietary intake at baseline using a food frequency questionnaire. STATISTICAL ANALYSES: The associations between DED and each incident cancer, or any obesity-related cancer, were examined using competing-risks regression models, with death as a competing risk. Body mass index-stratified models were generated to investigate body mass index as a potential modifying factor. RESULTS: DED was associated with higher body mass index (28.9±6.0 vs 26.3±4.9) and waist circumference (89.3±14.2 vs 82.4±12.4 cm) for DED quintiles 5 vs 1, respectively. DED was associated with a 10% increased risk of any obesity-related cancer (subhazard ratioQ5 vs Q1: 1.1, 95% CI 1.03 to 1.2; P=0.004). This increased risk appeared limited to women who were normal weight at enrollment. CONCLUSIONS: Higher DED may be a contributing factor for obesity-related cancers, especially among normal-weight postmenopausal women and, as such, could serve as a modifiable behavior for dietary interventions to reduce obesity-associated cancer risk.

Serum 25-hydroxyvitamin D concentrations and lung cancer risk in never-smoking postmenopausal women.

PURPOSE: Vitamin D has been implicated in lowering lung cancer risk, but serological data on the association among never-smoking women are limited. We report results examining the association of serum 25-hydroxyvitamin D [25(OH)D] concentrations with lung cancer risk among female never smokers. We also examined whether the association was modified by vitamin D supplementation and serum vitamin A concentrations. METHODS: In the Women's Health Initiative, including the calcium/vitamin D (CaD) Trial, we selected 298 incident cases [191 non-small cell lung cancer (NSCLC) including 170 adenocarcinoma] and 298 matched controls of never smokers. Baseline serum 25(OH)D was assayed by a chemiluminescent method. Logistic regression was used to estimate odds ratios (ORs) for quartiles and predefined clinical cutoffs of serum 25(OH)D concentrations. RESULTS: Comparing quartiles 4 versus 1 of serum 25(OH)D concentrations, ORs were 1.06 [95% confidence interval (CI) 0.61-1.84] for all lung cancer, 0.94 (95% CI 0.52-1.69) for NSCLC, and 0.91 (95% CI 0.49-1.68) for adenocarcinoma. Comparing serum 25(OH)D ≥ 75 (high) versus <30 nmol/L (deficient), ORs were 0.76 (95% CI 0.31-1.84) for all lung cancer, 0.71 (95% CI 0.27-1.86) for NSCLC, and 0.81 (95% CI 0.31-2.14) for adenocarcinoma. There is suggestive evidence that CaD supplementation (1 g calcium + 400 IU D3/day) and a high level of circulating vitamin A may modify the associations of 25(OH)D with lung cancer overall and subtypes (p interaction <0.10). CONCLUSIONS: In this group of never-smoking postmenopausal women, the results did not support the hypothesis of an association between serum 25(OH)D and lung cancer risk.

Calcium plus vitamin D supplementation and lung cancer incidence among postmenopausal women in the Women's Health Initiative.

BACKGROUND: Magnesium and calcium are antagonistic in many physiologic processes. However, few studies have investigated the associations of supplemental calcium with lung cancer risk taking this antagonism into account. We evaluated the effect of calcium and vitamin D supplementation on lung cancer incidence and explored whether the ratio of baseline calcium to magnesium (Ca:Mg) intake modifies the association in the Women's Health Initiative (WHI) calcium plus vitamin D supplementation (CaD) trial. METHODS: The intervention phase of the WHI CaD was a double-blinded, randomized, placebo-controlled trial in 36,382 postmenopausal women aged 50-79 years, recruited at 40U.S. centers. Post-intervention follow-up continued among 29,862 (86%) of the surviving participants. Risk of lung cancer in association with CaD supplementation was evaluated using proportional hazard regression models. RESULTS: After 11 years' cumulative follow-up, there were 207 lung cancers (incidence 0.11% per year) in the supplement arm and 241 (0.12%) in the placebo arm (hazard ratio (HR) for the intervention, 0.91; 95% confidence interval (CI), 0.71-1.17). Subgroup analyses suggested that the HR for lung cancer varied by baseline Ca:Mg intake ratio among women who were current smokers at enrollment (p=0.04 for interaction). CONCLUSIONS: Over the entire follow-up period, calcium and vitamin D supplementation did not reduce lung cancer incidence among postmenopausal women. In exploratory analyses, an interaction was found for the baseline Ca:Mg intake ratio on lung cancer among current smokers at the trial entry. This findings need to be further studied for the role of calcium with magnesium in lung carcinogenesis in current smokers.

Association between body composition and hip fractures in older women with physical frailty.

AIM: We sought to determine the extent to which higher lean and fat mass as measured by dual X-ray absorptiometry in older adults with frailty are related to total hip bone mass density (BMD) index and the rate of hip fractures. METHODS: The data are from the Women's Health Initiative Observational Study. We identified 872 participants aged ≥65 years with body composition measures and positive frailty. Frailty was determined using modified Fried's criteria. Linear and Cox regressions were used to model study outcomes. RESULTS: During the follow-up period, 5.6% patients (n = 49) had sustained a hip fracture. Body composition indexes were associated with total hip BMD (P < 0.001 for all). In models adjusted for age, ethnicity, smoking, history of fractures, recurrent falls, number of frailty criteria and corresponding lean mass, the hazard ratio for hip fracture per 1 kg/m2 increase in fat mass was 0.73 (95% confidence interval 0.60-0.88) for appendicular compartment, 0.76 (95% confidence interval 0.65-0.89) for trunk and 0.84 (95% confidence interval 0.77-0.93) for whole-body fat mass. The hazard ratio for hip fracture per 1 kg/m2 increase in appendicular lean mass was 0.63 (95% confidence interval 0.46-0.88). However, after final adjustment for total hip BMD, the only index that remained statistically significant was whole-body fat mass (P for trend = 0.04). CONCLUSIONS: We showed that in frail older women, higher fat and lean mass was associated with reduced hip-fracture rates. Higher whole-body adiposity, however, was also associated with lower hip-fracture rate independent of total hip BMD. The present results confirm the importance of weight maintenance in frail populations. Geriatr Gerontol Int 2017; 17: 898-904.

Body Mass Index, Waist Circumference, Diabetes, and Risk of Liver Cancer for U.S. Adults.

Incidence rates for liver cancer have increased 3-fold since the mid-1970s in the United States in parallel with increasing trends for obesity and type II diabetes mellitus. We conducted an analysis of baseline body mass index (BMI), waist circumference (WC), and type II diabetes mellitus with risk of liver cancer. The Liver Cancer Pooling Project maintains harmonized data from 1.57 million adults enrolled in 14 U.S.-based prospective studies. Cox regression estimated HRs and 95% confidence intervals (CI) adjusted for age, sex, study center, alcohol, smoking, race, and BMI (for WC and type II diabetes mellitus). Stratified analyses assessed whether the BMI-liver cancer associations differed by hepatitis sera-positivity in nested analyses for a subset of cases (n = 220) and controls (n = 547). After enrollment, 2,162 incident liver cancer diagnoses were identified. BMI, per 5 kg/m2, was associated with higher risks of liver cancer, more so for men (HR = 1.38; 95% CI, 1.30-1.46) than women (HR = 1.25; 95% CI, 1.17-1.35; Pinteraction = 0.02). WC, per 5 cm, was associated with higher risks of liver cancer, approximately equally by sex (overall, HR = 1.08; 95% CI, 1.04-1.13). Type II diabetes mellitus was associated with higher risk of liver cancer (HR = 2.61; 95% CI, 2.34-2.91). In stratified analyses, there was a null association between BMI and liver cancer risk for participants who were sera-positive for hepatitis. This study suggests that high BMI, high WC, and type II diabetes mellitus are associated with higher risks of liver cancer and that the association may differ by status of viral hepatitis infection. Cancer Res; 76(20); 6076-83. ©2016 AACR.

Serum calcium, albumin and tumor stage in cutaneous malignant melanoma.

AIM: Assess the relationship of serum calcium and serum albumin to tumor stage and other clinical characteristics in patients with cutaneous malignant melanoma (MM). PATIENTS & METHODS: A cross-sectional study to evaluate serum calcium as a marker of disease progression (n = 644) in MM. RESULTS: Serum albumin was significantly lower among men (p < 0.01) and among patients with stage 4 disease (p < 0.05). In a multivariable regression model adjusted for age, gender and site, albumin-corrected calcium was positively associated with disease stage (odds ratio: 1.46; 95% CI: 1.02-2.07; p = 0.04). The odds of higher stage increased 60% for each 1.0 mg/dl increase in albumin-corrected calcium. CONCLUSION: Higher albumin-corrected serum calcium may be a marker of disease progression in MM.

Food Fortification and Supplement Use-Are There Health Implications?

UNLABELLED: Dietary supplements are a multi-billion dollar industry in the U.S., and their use is increasing exponentially. Additionally, many foods and beverages are increasingly being fortified with single or multiple vitamins and minerals. Consequently, nutrient intakes are exceeding the safe limits established by the Institute of Medicine. In this paper, we examine the benefits and drawbacks of vitamin and mineral supplements and increasing consumption of fortified foods (in addition to dietary intake) in the U.S. POPULATION: The pros and cons are illustrated using population estimates of folic acid, calcium, and vitamin D intake, highlighting concerns related to overconsumption of nutrients that should be addressed by regulatory agencies.

Dietary and serum lycopene levels in prostate cancer patients undergoing intensity-modulated radiation therapy.

Tomato products, good sources of lycopene, may lower the incidence of prostate cancer, but data on the effectiveness of lycopene supplementation during radiation therapy are lacking. This study aimed to evaluate the tolerance and acceptance of three different amounts (4, 8, or 12 oz) of tomato juice (TJ) and their effect on serum lycopene during radiotherapy in 20 men with localized prostate cancer. Participants were randomized into a control group or one of three intervention groups who consumed TJ daily during treatment. Dietary lycopene intake was estimated using the National Cancer Institute (NCI) Diet History Questionnaire, and gastrointestinal tolerance of TJ was evaluated using the NCI Cancer Therapy Evaluation Program: Common Toxicity Criteria v 2.0. Serum and TJ lycopene levels were measured by liquid chromatography-mass spectrometry. TJ was well tolerated without any gastrointestinal side effects, and increased serum lycopene levels were observed in the 8 and 12 oz groups from baseline to endpoint. No correlation between serum and dietary lycopene was detected. Despite no reported change in dietary intake, non-significant weight loss was observed in the control group but not the intervention group participants. A significant positive correlation between serum lycopene, weight, and body mass index, and a negative correlation between serum lycopene and piror nutritional supplement use was detected. Weight change should be monitored and evaluated during treatment. Larger clinical trials are needed to validate the use of TJ to increase serum/dietary lycopene intake and correlate with side effects during radiotherapy in men with prostate cancer.

Calcium and vitamin D supplementation and loss of bone mineral density in women undergoing breast cancer therapy.

An unintended consequence of breast cancer therapies is an increased risk of osteoporosis due to accelerated bone loss. We conducted a systematic review of calcium and/or vitamin D (Ca±D) supplementation trials for maintaining bone mineral density (BMD) in women with breast cancer using the "before-after" data from the Ca±D supplemented comparison group of trials evaluating the effect of drugs such as bisphosphonates on BMD. Whether Ca±D supplements increase BMD in women undergoing breast cancer therapy has never been tested against an unsupplemented control group. However, results from 16 trials indicate that the Ca±D doses tested (500-1500mg calcium; 200-1000IU vitamin D) were inadequate to prevent BMD loss in these women. Cardiovascular disease is the main cause of mortality in women with breast cancer. Because calcium supplements may increase cardiovascular disease risk, future trials should evaluate the safety and efficacy of Ca±D supplementation in women undergoing breast cancer therapy.

Body fat and breast cancer risk in postmenopausal women: a longitudinal study.

Associations between anthropometric indices of obesity and breast cancer risk may fail to capture the true relationship between excess body fat and risk. We used dual-energy-X-ray-absorptiometry- (DXA-) derived measures of body fat obtained in the Women's Health Initiative to examine the association between body fat and breast cancer risk; we compared these risk estimates with those for conventional anthropometric measurements. The study included 10,960 postmenopausal women aged 50-79 years at recruitment, with baseline DXA measurements and no history of breast cancer. During followup (median: 12.9 years), 503 incident breast cancer cases were diagnosed. Hazard ratios (HR) and 95% confidence intervals (CI) were estimated using Cox proportional hazards models. All baseline DXA-derived body fat measures showed strong positive associations with breast cancer risk. The multivariable-adjusted HR for the uppermost quintile level (versus lowest) ranged from 1.53 (95% CI 1.14-2.07) for fat mass of the right leg to 2.05 (1.50-2.79) for fat mass of the trunk. Anthropometric indices (categorized by quintiles) of obesity (BMI (1.97, 1.45-2.68), waist circumference (1.97, 1.46-2.65), and waist : hip ratio (1.91, 1.41-2.58)) were all strongly, positively associated with risk and did not differ from DXA-derived measures in prediction of risk.

Calcium and vitamin D supplementation during androgen deprivation therapy for prostate cancer: a critical review.

BACKGROUND: Loss of bone mineral density is an unintended consequence of androgen deprivation therapy in men with prostate cancer. Supplementation with calcium and/or vitamin D in these men seems logical and is advocated by many lay and professional groups. METHODS: We reviewed guidelines for calcium and vitamin D supplementation and the results of clinical trials of calcium and vitamin D supplementation on bone mineral density in men with prostate cancer undergoing androgen deprivation therapy. RESULTS: Whether supplementation of men undergoing androgen deprivation therapy with calcium and/or vitamin D results in higher bone mineral density than no supplementation has not been tested. The results of 12 clinical trials show that, at the doses commonly recommended, 500-1,000 mg calcium and 200-500 IU vitamin D per day, men undergoing androgen deprivation lose bone mineral density. CONCLUSION: The doses of calcium and vitamin D that have been tested are inadequate to prevent loss of bone mineral density in men undergoing androgen deprivation therapy. In light of evidence that high levels of dietary calcium and calcium supplement use are associated with higher risks for cardiovascular disease and advanced prostate cancer, intervention studies should evaluate the safety as well as the efficacy of calcium and vitamin D supplementation in these men.