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Contemporary clinical trials 18건

  1. [해외논문]   Editorial Board   SCI SCIE


    Contemporary clinical trials v.67 ,pp. ii - ii , 2018 , 1551-7144 ,

    초록

    원문보기

    원문보기
    무료다운로드 유료다운로드

    회원님의 원문열람 권한에 따라 열람이 불가능 할 수 있으며 권한이 없는 경우 해당 사이트의 정책에 따라 회원가입 및 유료구매가 필요할 수 있습니다.이동하는 사이트에서의 모든 정보이용은 NDSL과 무관합니다.

    NDSL에서는 해당 원문을 복사서비스하고 있습니다. 아래의 원문복사신청 또는 장바구니담기를 통하여 원문복사서비스 이용이 가능합니다.

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    Fig. 1 이미지
  2. [해외논문]   Promoting Successful Weight Loss in Primary Care in Louisiana (PROPEL): Rationale, design and baseline characteristics   SCI SCIE

    Katzmarzyk, Peter T. (Pennington Biomedical Research Center, Baton Rouge, LA, United States ) , Martin, Corby K. (Pennington Biomedical Research Center, Baton Rouge, LA, United States ) , Newton Jr, Robert L. (Pennington Biomedical Research Center, Baton Rouge, LA, United States ) , Apolzan Jr, John W. (Pennington Biomedical Research Center, Baton Rouge, LA, United States ) , Arnold Jr, Connie L. (Department of Medicine, Feist-Weiller Cancer Center, Louisiana State University Health Sciences Center, Shreveport, LA, United States ) , Davis Jr, Terry C. (Department of Medicine, Feist-Weiller Cancer Center, Louisiana State University Health Sciences Center, Shreveport, LA, United States ) , Denstel Jr, Kara D. (Pennington Biomedical Research Center, Baton Rouge, LA, United States ) , Mire Jr, Emily F. (Pennington Biomedical Research Center, Baton Rouge, LA, United States ) , Thethi Jr, Tina K. (Department of Medicine, Division of Endocrinology and Metabolism, Tulane University Health Sciences Center, School of Medicine, New Orleans, LA, United States ) , Brantley Jr, Phillip J. (Pennington Biomedical Research Center, Baton Rouge, LA, United States ) , Johnson Jr, William D. (Pennington Biomedical Research Center, Baton Rouge, LA, United) , Fonseca Jr, Vivian , Gugel Jr, Jonathan , Kennedy Jr, Kathleen B. , Lavie Jr, Carl J. , Price-Haywood Jr, Eboni G. , Sarpong Jr, Daniel F. , Springgate Jr, Benjamin
    Contemporary clinical trials v.67 ,pp. 1 - 10 , 2018 , 1551-7144 ,

    초록

    Abstract Underserved and minority populations suffer from a disproportionately high prevalence of obesity and related comorbidities. Effective obesity treatment programs delivered in primary care that produce significant weight loss are currently lacking. The purpose of this trial is to test the effectiveness of a pragmatic, high intensity lifestyle-based obesity treatment program delivered within primary care among an underserved population. We hypothesize that, relative to patients who receive usual care, patients who receive a high-intensity, health literacy- and culturally-appropriate lifestyle intervention will have greater percent reductions in body weight over 24 months. Eighteen clinics (N = 803 patients) serving low income populations with a high proportion of African Americans in Louisiana were randomized to the intervention or usual car. Patients in the intervention participate in a high-intensity lifestyle program delivered by health coaches employed by an academic health center and embedded in the primary care clinics. The program consists of weekly (16 in-person/6 telephone) sessions in the first six months, followed by sessions held at least monthly for the remaining 18 months. Primary care practitioners in usual care receive information on weight management and the current Centers for Medicare and Medicaid Services reimbursement for obesity treatment. The primary outcome is percent weight loss at 24 months. Secondary outcomes include absolute 24-month changes in body weight, waist circumference, blood pressure, fasting glucose and lipids, health-related quality of life, and weight-related quality of life. The results will provide evidence on the effectiveness of implementing high-intensity lifestyle and obesity counseling in primary care settings among underserved populations. Trial Registration: ClinicalTrials.gov Identifier NCT02561221

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    원문보기
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    회원님의 원문열람 권한에 따라 열람이 불가능 할 수 있으며 권한이 없는 경우 해당 사이트의 정책에 따라 회원가입 및 유료구매가 필요할 수 있습니다.이동하는 사이트에서의 모든 정보이용은 NDSL과 무관합니다.

    NDSL에서는 해당 원문을 복사서비스하고 있습니다. 아래의 원문복사신청 또는 장바구니담기를 통하여 원문복사서비스 이용이 가능합니다.

    이미지

    Fig. 1 이미지
  3. [해외논문]   Participatory Research to Advance Colon Cancer Prevention (PROMPT): Study protocol for a pragmatic trial   SCI SCIE

    Thompson, Jamie H. (The Center for Health Research, Kaiser Permanente Northwest, 3800 N. Interstate Avenue, Portland, Oregon 97227, USA ) , Davis, Melinda M. (Oregon Rural Practice-based Research Network (ORPRN), Oregon Health & Science University, 3181 S.W. Sam Jackson Park Road, Portland, Oregon 97239, USA ) , Leo, Michael C. (The Center for Health Research, Kaiser Permanente Northwest, 3800 N. Interstate Avenue, Portland, Oregon 97227, USA ) , Schneider, Jennifer L. (The Center for Health Research, Kaiser Permanente Northwest, 3800 N. Interstate Avenue, Portland, Oregon 97227, USA ) , Smith, David H. (The Center for Health Research, Kaiser Permanente Northwest, 3800 N. Interstate Avenue, Portland, Oregon 97227, USA ) , Petrik, Amanda F. (The Center for Health Research, Kaiser Permanente Northwest, 3800 N. Interstate Avenue, Portland, Oregon 97227, USA ) , Castillo, Melissa (AltaMed, 2040 Camfield Avenue, Los Angeles, CA 90040, USA ) , Younger, Brittany (AltaMed, 2040 Camfield Avenue, Los Angeles, CA 90040, USA ) , Coronado, Gloria D. (The Center for Health Research, Kaiser Permanente Northwest, 3800 N. Interstate Avenue, Portland, Oregon 97227, USA)
    Contemporary clinical trials v.67 ,pp. 11 - 15 , 2018 , 1551-7144 ,

    초록

    Abstract Background Colon cancer is the second leading cause of cancer deaths in the United States. The Participatory Research to Advance Colon Cancer Prevention (PROMPT) study is a collaboration between two research institutions and a federally qualified health center (FQHC). The study seeks to raise colon cancer screening rates using a direct-mail fecal immunochemical testing (FIT) and reminder program in an FQHC serving a predominantly Latino population in California. Methods PROMPT is a pragmatic trial enrolling 16 clinics. The study will test automated and live prompts (i.e., alerts, reminders) to a direct-mail FIT program in two phases. In Phase I, we tailored and defined intervention components for the pilot using a community-based participatory research approach called boot camp translation. We then plan to conduct a three-arm patient-randomized comparative effectiveness trial in two pilot clinics to compare 1) automated prompts, 2) live prompts, and 3) a combination of automated plus live prompts to alert and remind patients to complete screening. In Phase II, the adapted best practice intervention will be spread to additional clinics within the FQHC (estimated population 27,000) and assessed for effectiveness. Patient and staff interviews will be conducted to explore receptivity to the program and identify barriers to implementation. Discussion This pragmatic trial applies innovative approaches to engage diverse stakeholders and will test the effectiveness and spread of a direct-mail plus reminder program. If successful, the program will provide a model for a cost-effective method to raise colon cancer screening rates among Latino patients receiving care in FQHCs. Trial registration National Clinical Trial (NCT) Identifier NCT03167125.

    원문보기

    원문보기
    무료다운로드 유료다운로드

    회원님의 원문열람 권한에 따라 열람이 불가능 할 수 있으며 권한이 없는 경우 해당 사이트의 정책에 따라 회원가입 및 유료구매가 필요할 수 있습니다.이동하는 사이트에서의 모든 정보이용은 NDSL과 무관합니다.

    NDSL에서는 해당 원문을 복사서비스하고 있습니다. 아래의 원문복사신청 또는 장바구니담기를 통하여 원문복사서비스 이용이 가능합니다.

    이미지

    Fig. 1 이미지
  4. [해외논문]   Rationale and design of the Clinic and Community Approaches to Healthy Weight Randomized Trial   SCI SCIE

    Fiechtner, Lauren (Division of General Academic Pediatrics, Department of Pediatrics, MassGeneral Hospital for Children, 125 Nashua Street, Suite 860, Boston, MA 02114, USA ) , Perkins, Meghan (Division of General Academic Pediatrics, Department of Pediatrics, MassGeneral Hospital for Children, 125 Nashua Street, Suite 860, Boston, MA 02114, USA ) , Biggs, Vincent (Holyoke Community Health Center, Department of Pediatrics, 230 Maple St., Holyoke, MA 01040, USA ) , Langhans, Nancy (Greater New Bedford Community Health Center, Department of Pediatrics, 874 Purchase St., New Bedford, MA 02740, USA ) , Sharifi, Mona (Section of General Pediatrics, Department of Pediatrics, Yale University School of Medicine, 333 Cedar Street, PO Box 208064, New Haven, CT 06520, USA ) , O'Connor, Giselle (Division of General Academic Pediatrics, Department of Pediatrics, MassGeneral Hospital for Children, 125 Nashua Street, Suite 860, Boston, MA 02114, USA ) , Price, Sarah (Division of General Academic Pediatrics, Department of Pediatrics, MassGeneral Hospital for Children, 125 Nashua Street, Suite 860, Boston, MA 02114, USA ) , Locascio, Joseph (Depart) , Kuhlthau, Karen , Kwass, Jo-Ann , Nelson, Candace , Land, Thomas , Longjohn, Matt , Lawson, Valerie , Hohman, Katherine , Taveras, Elsie M.
    Contemporary clinical trials v.67 ,pp. 16 - 22 , 2018 , 1551-7144 ,

    초록

    Abstract Background Recent studies have demonstrated the effectiveness of family-centered, pediatric weight management programs in reducing childhood obesity. Yet, programs to optimize the care of low-income children with obesity are needed. We sought to examine the comparative effectiveness of two, potentially scalable pediatric weight management programs delivered to low-income children in a clinical or community setting. Materials and methods The Clinic and Community Approaches to Healthy Weight Trial is a randomized trial in two communities in Massachusetts that serve a large population of low-income children and families. The two-arm trial compares the effects of a pediatric weight management program delivered in the Healthy Weight Clinics of two federally qualified health centers (FQHC) to the Healthy Weight and Your Child programs delivered in two YMCAs. Eligible children are 6 to 12 years old with a body mass index (BMI) ≥ 85th percentile seen in primary care at the two FQHCs. Both programs are one-year in duration and have at least 30 contact hours throughout the year. Measures are collected at baseline, 6 months, and 1 year. The main outcome is 1-year change in BMI (kg/m 2 ) and percent change of the 95th percentile (%BMIp 95 ). Conclusion The Clinic and Community Approaches to Healthy Weight Trial seeks to 1) examine the comparative effects of a clinical and community based intervention in improving childhood obesity, and 2) inform the care of >7 million children with obesity covered by the Children's Health Insurance Program or Medicaid.

    원문보기

    원문보기
    무료다운로드 유료다운로드

    회원님의 원문열람 권한에 따라 열람이 불가능 할 수 있으며 권한이 없는 경우 해당 사이트의 정책에 따라 회원가입 및 유료구매가 필요할 수 있습니다.이동하는 사이트에서의 모든 정보이용은 NDSL과 무관합니다.

    NDSL에서는 해당 원문을 복사서비스하고 있습니다. 아래의 원문복사신청 또는 장바구니담기를 통하여 원문복사서비스 이용이 가능합니다.

    이미지

    Fig. 1 이미지
  5. [해외논문]   The Physical Activity Daily (PAD) Trial: The rationale and design of a randomized controlled trial evaluating an internet walking program to improve maximal walking distance among patients with peripheral arterial disease   SCI SCIE

    Kumar, Anjana M. (Michigan State University, College of Human Medicine, 15 Michigan Street, Grand Rapids, MI 49503, USA ) , Lyden, Angela K. (Department of Internal Medicine, Division of Cardiology, University of Michigan School of Medicine, 1500 E Medical Center Drive, Ann Arbor, MI 48109-0708, USA ) , Carlozzi, Noelle E. (Department of Physical Medicine and Rehabilitation, Center for Clinical Outcomes, Development, and Application (CODA), University of Michigan School of Medicine, 2800 Plymouth Rd, Ann Arbor, MI 48109-2800, USA ) , Sen, Ananda (Department of Family Medicine, University of Michigan School of Medicine, 1018 Fuller Street, Ann Arbor, MI 48109-0708, USA ) , Richardson, Caroline R. (Department of Family Medicine, University of Michigan School of Medicine, 1018 Fuller Street, Ann Arbor, MI 48109-0708, USA ) , Jackson, Elizabeth A. (Department of Internal Medicine, Division of Cardiology, University of Michigan School of Medicine, 1500 E Medical Center Drive, Ann Arbor, MI 48109-0708, USA)
    Contemporary clinical trials v.67 ,pp. 23 - 30 , 2018 , 1551-7144 ,

    초록

    Abstract Background Despite established guidelines for regular walking as a first line therapy for adults with peripheral arterial disease (PAD), most patients do not walk routinely. This paper presents the design specifications for a randomized clinical trial to examine the effectiveness of an internet-based walking program compared to a telephone intervention, or the combination (internet-based with telephone counseling) for promotion of regular walking in patients with PAD. Methods Sedentary adults with documented lower extremity PAD are being recruited from the University of Michigan Health System and the surrounding area. Participants are randomized to one of four arms in a 2×2 factorial design: 1) telephone counseling to promote walking, 2) an internet-based walking program with tailored step-count goals, 3) the combination of telephone counseling with the internet-based walking program, or 4) waitlist control. Participants receive a 4-month intervention phase, after which all participants are followed for an additional 8months to assess long-term adherence to regular walking. Outcomes are assessed at baseline, 4 and 12months. The primary outcome is walking distance assessed through a standardized treadmill protocol. Additional outcomes include change in step-counts measured with a commercial activity tracker, pain-free walking distance, and changes in health-related quality of life from baseline to follow-up. Conclusion Finding effective and feasible programs to promote walking among PAD patients is warranted. This study will add to current evidence regarding use of internet based programs with and without telephone counseling to promote regular walking in this population.

    원문보기

    원문보기
    무료다운로드 유료다운로드

    회원님의 원문열람 권한에 따라 열람이 불가능 할 수 있으며 권한이 없는 경우 해당 사이트의 정책에 따라 회원가입 및 유료구매가 필요할 수 있습니다.이동하는 사이트에서의 모든 정보이용은 NDSL과 무관합니다.

    NDSL에서는 해당 원문을 복사서비스하고 있습니다. 아래의 원문복사신청 또는 장바구니담기를 통하여 원문복사서비스 이용이 가능합니다.

    이미지

    Fig. 1 이미지
  6. [해외논문]   Evaluation of the extent of adaptation to sample size in clinical trials for cardiovascular and CNS diseases   SCI SCIE

    Wang, Sue-Jane (Office of Biostatistics, Office of Translational Sciences, CDER, FDA, Silver Spring, MD 20993, USA ) , Peng, Hua (Department of Statistics, University of California, Riverside, CA, USA ) , Hung, Hsien-Ming James (Division of Biometrics I, Office of Biostatistics, OTS, CDER, FDA, Silver Spring, MD 20993, USA)
    Contemporary clinical trials v.67 ,pp. 31 - 36 , 2018 , 1551-7144 ,

    초록

    Abstract A planned adaptation to sample size in an ongoing trial aims at providing an opportunity to modify design assumptions made at the trial planning stage. Reassessment of sample size in an ongoing trial may be performed in a non-comparative or a comparative fashion, either with or without use of external data that surface. We review the completed new drug applications (NDAs) and biologic license applications (BLAs) submitted since 2000 to cardio-renal, neurology and psychiatry drug products divisions of Center for Drug Evaluation and Research, U.S. Food and Drug Administration. Interestingly, it was found that the maximal sample size increase across the identified confirmatory clinical trials was less than 2-fold the originally planned sample size. Additionally, as a result of sample size increase, precision in treatment effect estimation was often improved for the primary endpoint and the key secondary endpoints.

    원문보기

    원문보기
    무료다운로드 유료다운로드

    회원님의 원문열람 권한에 따라 열람이 불가능 할 수 있으며 권한이 없는 경우 해당 사이트의 정책에 따라 회원가입 및 유료구매가 필요할 수 있습니다.이동하는 사이트에서의 모든 정보이용은 NDSL과 무관합니다.

    NDSL에서는 해당 원문을 복사서비스하고 있습니다. 아래의 원문복사신청 또는 장바구니담기를 통하여 원문복사서비스 이용이 가능합니다.

    이미지

    Fig. 1 이미지
  7. [해외논문]   Weight management in rural health clinics: The Midwest diet and exercise trial   SCI SCIE

    Gorczyca, Anna M. (Cardiovascular Research Center, Division of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd., Kansas City, KS 66160, USA ) , Washburn, Richard A. (Cardiovascular Research Center, Division of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd., Kansas City, KS 66160, USA ) , Ptomey, Lauren (Cardiovascular Research Center, Division of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd., Kansas City, KS 66160, USA ) , Mayo, Matthew S. (Department of Biostatistics, The University of Kansas Medical Center, 3901 Rainbow Blvd., Kansas City, KS 66160, USA ) , Sullivan, Debra K. (Department of Dietetics and Nutrition, The University of Kansas Medical Center, 3901 Rainbow Blvd., Kansas City, KS 66160, USA ) , Gibson, Cheryl A. (Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd., Kansas City, KS 66160, USA ) , Lee, Robert (Department of Health Policy and Management, The University of Kansas Medical Center, 3901 Rainbow Blvd., Kansas City, KS 66160, USA ) , Stolte, Sarah (Department of Internal Medicine, The) , Donnelly, Joseph E.
    Contemporary clinical trials v.67 ,pp. 37 - 46 , 2018 , 1551-7144 ,

    초록

    Abstract Obesity prevalence is higher in rural compared to urban residents. Rural health clinics offer a potential venue for delivery of weight management. However, traditional programs require travel to attend on-site meetings which is impractical or inconvenient for rural residents. Clinic staff in most rural settings are unlikely to be trained to provide effective weight management. Remote delivery using group phone conferences (GP) or individual phone calls (IP), by staff associated with rural clinics eliminates the need for travel to attend on-site meetings. The effectiveness of these approaches will be the focus of this trial. Staff at five primary care clinics, serving primarily rural residents, will be trained to deliver GP and IP interventions and an enhanced usual care (EUC), (i.e., individual face-to-face meetings (~45 min) at clinic site, four times across 18 mos.). Two hundred overweight/obese adults (BMI ≥ 25.0–45.0 kg/m 2 , age ≥ 21 yrs.) will be recruited through each clinic and randomized to GP (n = 80), IP (n = 80), or EUC (n = 40) to compare weight loss (0–6 mos.), weight maintenance (7–18 mos.), and weight change during a 6 mo. no contact follow-up (19–24 mos.) between intervention arms. The GP and IP interventions will be identical in lesson plan content, diet, and physical activity. The only difference between groups will be the delivery format (group vs. individual) and session duration (GP ~45 min/session; IP ~15 min/session). Primary (body weight) and secondary outcomes (waist circumference, energy/macronutrient intake, physical activity) will be assessed at baseline, 6, 12, 18 and 24 mos. Cost and contingent valuation analyses will also be completed. NCT registration NCT02932748.

    원문보기

    원문보기
    무료다운로드 유료다운로드

    회원님의 원문열람 권한에 따라 열람이 불가능 할 수 있으며 권한이 없는 경우 해당 사이트의 정책에 따라 회원가입 및 유료구매가 필요할 수 있습니다.이동하는 사이트에서의 모든 정보이용은 NDSL과 무관합니다.

    NDSL에서는 해당 원문을 복사서비스하고 있습니다. 아래의 원문복사신청 또는 장바구니담기를 통하여 원문복사서비스 이용이 가능합니다.

    이미지

    Fig. 1 이미지
  8. [해외논문]   A cluster randomized pilot trial of a tailored worksite smoking cessation intervention targeting Hispanic/Latino construction workers: Intervention development and research design   SCI SCIE

    Asfar, Taghrid (Department of Public Health Sciences, University of Miami Miller School of Medicine, 1120 NW 14<sup>th</sup>St, 9<sup>th</sup>Floor, Miami, FL 33136, United States ) , Caban-Martinez, Alberto J. (Department of Public Health Sciences, University of Miami Miller School of Medicine, 1120 NW 14<sup>th</sup>St, 9<sup>th</sup>Floor, Miami, FL 33136, United States ) , McClure, Laura A. (Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, 1120 NW 14<sup>th</sup>St, 9<sup>th</sup>Floor, Miami, FL 33136, United States ) , Ruano-Herreria, Estefania C. (Department of Public Health Sciences, University of Miami Miller School of Medicine, 1120 NW 14<sup>th</sup>St, 9<sup>th</sup>Floor, Miami, FL 33136, United States ) , Sierra, Danielle (Department of Public Health Sciences, University of Miami Miller School of Medicine, 1120 NW 14<sup>th</sup>St, 9<sup>th</sup>Floor, Miami, FL 33136, United States ) , Gilford Clark Jr, G. (Department of Public Health Sciences, University of Miami Miller School of Medicine, 1120 NW 14<sup>th</sup>St, 9<sup>th</sup>Floor, Miami, FL 33136, United) , Samano Jr, Daniel , Dietz Jr, Noella A. , Ward Jr, Kenneth D. , Arheart Jr, Kristopher L. , Lee Jr, David J.
    Contemporary clinical trials v.67 ,pp. 47 - 55 , 2018 , 1551-7144 ,

    초록

    Abstract Construction workers have the highest smoking rate among all occupations (39%). Hispanic/Latino workers constitute a large and increasing group in the US construction industry (over 2.6 million; 23% of all workers). These minority workers have lower cessation rates compared to other groups due to their limited access to cessation services, and lack of smoking cessation interventions adapted to their culture and work/life circumstances. Formative research was conducted to create an intervention targeting Hispanic/Latino construction workers. This paper describes the intervention development and the design, methods, and data analysis plans for an ongoing cluster pilot two-arm randomized controlled trial comparing an Enhanced Care worksite cessation program to Standard Care. Fourteen construction sites will be randomized to either Enhanced Care or Standard Care and 126 participants (63/arm) will be recruited. In both arms, recruitment and intervention delivery occur around “food trucks” that regularly visit the construction sites. Participants at Enhanced Care sites will receive the developed intervention consisting of a single face-to-face group counseling session, 2 phone calls, and a fax referral to Florida tobacco quitline (QL). Participants at Standard Care sites will receive a fax referral to the QL. Both groups will receive eight weeks of nicotine replacement treatment and two follow-up assessments at three and six months. Feasibility outcomes are estimated recruitment yield, barriers to delivering the intervention onsite, and rates of adherence/compliance to the intervention, follow-ups, and QL enrollment. Efficacy outcomes are point-prevalence and prolonged abstinence rates at six month follow-up confirmed by saliva cotinine

    원문보기

    원문보기
    무료다운로드 유료다운로드

    회원님의 원문열람 권한에 따라 열람이 불가능 할 수 있으며 권한이 없는 경우 해당 사이트의 정책에 따라 회원가입 및 유료구매가 필요할 수 있습니다.이동하는 사이트에서의 모든 정보이용은 NDSL과 무관합니다.

    NDSL에서는 해당 원문을 복사서비스하고 있습니다. 아래의 원문복사신청 또는 장바구니담기를 통하여 원문복사서비스 이용이 가능합니다.

    이미지

    Fig. 1 이미지
  9. [해외논문]   Baseline characteristics of participants in the VITamin D and OmegA-3 TriaL (VITAL): Effects on Bone Structure and Architecture   SCI SCIE

    Donlon, Catherine M. (Division of Endocrinology, Diabetes and Hypertension, Department of Medicine, Brigham and Women's Hospital, Boston, MA 02115, United States ) , LeBoff, Meryl S. (Division of Endocrinology, Diabetes and Hypertension, Department of Medicine, Brigham and Women's Hospital, Boston, MA 02115, United States ) , Chou, Sharon H. (Division of Endocrinology, Diabetes and Hypertension, Department of Medicine, Brigham and Women's Hospital, Boston, MA 02115, United States ) , Cook, Nancy R. (Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, United States ) , Copeland, Trisha (Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, United States ) , Buring, Julie E. (Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, United States ) , Bubes, Vadim (Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, United Sta) , Kotler, Gregory , Manson, JoAnn E.
    Contemporary clinical trials v.67 ,pp. 56 - 67 , 2018 , 1551-7144 ,

    초록

    Abstract Vitamin D supplements are often used to benefit skeletal health, although data on effects of daily high-dose vitamin D alone on bone density and structure are lacking. The ongoing VITamin D and OmegA-3 TriaL (VITAL) is a double-blind, randomized, placebo-controlled trial testing effects of high-dose supplemental vitamin D 3 (cholecalciferol; 2000 IU/day) and/or omega-3 fatty acids (FAs; 1 g/day) for the primary prevention of cancer and cardiovascular disease. The study has a mean treatment period of 5 years among 25,874 U.S. men ≥50 years and women ≥55 years old from all 50 states. The ancillary study, VITAL: Effects on Bone Structure and Architecture , is testing effects of vitamin D 3 and/or omega-3 FAs on musculoskeletal outcomes and body composition in a subcohort of 771 participants. At in-person visits at the Harvard Catalyst Clinical and Translational Science Center (CTSC), participants completed bone density/architecture, body composition, and physical performance assessments at baseline and two-year follow-up. Baseline characteristics were evenly distributed among treatment groups, suggesting that any uninvestigated confounders will be evenly distributed; sex differences were also analyzed. Future analyses of the two-year follow-up visits will elucidate whether daily high-dose, supplemental vitamin D 3 and/or omega-3 FAs improve musculoskeletal outcomes, helping to advance clinical and public health recommendations. Clinical trial registration number: NCT01747447.

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  10. [해외논문]   Methods and procedures for: A randomized double-blind study investigating dose-dependent longitudinal effects of vitamin D supplementation on bone health   SCI SCIE

    Burt, Lauren A. (Department of Radiology, Cumming School of Medicine, University of Calgary, Calgary, Canada ) , Gaudet, Sharon (McCaig Institute for Bone and Joint Health, University of Calgary, Calgary, Canada ) , Kan, Michelle (Department of Radiology, Cumming School of Medicine, University of Calgary, Calgary, Canada ) , Rose, Marianne S. (Research Facilitation, Alberta Health Services, Calgary, Canada ) , Billington, Emma O. (McCaig Institute for Bone and Joint Health, University of Calgary, Calgary, Canada ) , Boyd, Steven K. (Department of Radiology, Cumming School of Medicine, University of Calgary, Calgary, Canada ) , Hanley, David A. (McCaig Institute for Bone and Joint Health, University of Calgary, Calgary, Canada)
    Contemporary clinical trials v.67 ,pp. 68 - 73 , 2018 , 1551-7144 ,

    초록

    Abstract The optimum dose of vitamin D and corresponding serum 25-hydroxyvitamin D (25OHD) concentration for bone health is still debated and some health practitioners are recommending doses well above the Canada/USA recommended Dietary Reference Intake (DRI). We designed a three-year randomized double-blind clinical trial investigating whether there are dose-dependent effects of vitamin D supplementation above the Dietary Reference Intake (DRI) on bone health. The primary aims of this study are to assess, whether supplementation of vitamin D 3 increases 1) volumetric bone mineral density measured by high-resolution peripheral quantitative computed tomography (HR-pQCT); 2) bone strength assessed by finite element analysis, and 3) areal bone mineral density by dual X-ray absorptiometry (DXA). Secondary aims are to understand whether vitamin D 3 supplementation improves parameters of bone microarchitecture, balance, physical function and quality of life. Participants are men and women aged 55–70 years, with women at least 5-years post-menopause. The intervention is daily vitamin D 3 supplementation doses of 400, 4000 or 10,000 IU. Participants not achieving adequate dietary calcium intake are provided with calcium supplementation, up to a maximum supplemental dose of 600 mg elemental calcium per day. Results from this three-year study will provide evidence whether daily vitamin D 3 supplementation with adequate calcium intake can affect bone density, bone microarchitecture and bone strength in men and women. Furthermore, the safety of high dose daily vitamin D 3 supplementation will be explored.

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