Vitamin D and Calcium in Midlife Women

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1 Vitamin D and Calcium in Midlife Women JoAnn E. Manson, MD, DrPH, NCMP Chief, Division of Preventive Medicine Brigham and Women's Hospital Professor of Medicine and the Michael and Lee Bell Professor of Women's Health Harvard Medical School North American Menopause Society Annual Meeting Orlando, FL October 8, 2016 Faculty/Presenter Disclosure I have no financial conflicts of interest related to this presentation. Objectives To review current guidelines for intake of calcium and vitamin D in midlife women. To summarize the evidence on calcium/vitamin D and the risk of fractures, falls, cardiovascular disease, cancer, and all-cause mortality. To present an update on the status of ongoing randomized trials of vitamin D nationally and internationally. Calcium and Vitamin D Dietary Reference Intakes for Adults, by Life Stage Life Stage (gender) RDA (mg/d) Calcium Tolerable upper intake level (mg/d)* RDA (IU/d) Vitamin D Tolerable upper intake level (IU/d)* yr (men and women) 1,000 2, , yr (men) 1,000 2, , yr (women) 1,200 2, , yr (men and women) 1,200 2, ,000 RDA = Recommended Dietary Allowance *The tolerable upper intake level is the threshold above which is a risk of adverse events. Source: Ross AC, Manson JE, Abrams SA, et al. J Clin Endocrinol Metab 2011; 96(1):53. 1

2 Osteoporosis : Public Health Impact At age 50, lifetime risk of fracture is 1:2 women 1:5 men Affects 10 million Americans 8 million women 2 million men 2 million fractures yearly (more common in women than MI, stroke, and breast cancer combined) WHI Calcium/Vitamin D (Ca/D) Trial Design: Double Blind N=36,282 women Randomization (50%) (50%) Intervention (CaD supplement) 1000 mg elemental calcium as calcium carbonate and 400 IU vitamin D 3 Control () NOF Fast Facts, Burge R, et al. J Bone Miner Res 2007; 22: Bone Mineral Density Results Greater preservation in total hip BMD Average differences between CaD and placebo groups: 0.59% at year % at year % at year 9 Rate of Hip Fracture (Cases/10,000/Yr) Calcium/Vitamin D Supplementation and Risk of Hip Fracture: WHI 20 Ca/D Group N = 175 Ca/D Group N = 199 Group Group HR = 0.88 (95% CI, ) P = 0.23 (n=374 cases) 2

3 Additional Fracture Findings Calcium/Vitamin D and Risk of Hip Fracture, Stratified by Baseline Intake of Supplemental and Dietary Calcium 29% fewer hip fractures in CaD than placebo (HR 0.71; 95% CI ) in adherent women (>80% of study pills) 21% fewer hip fractures among women 60 years (HR 0.79; 95% CI ; p for interaction by age = 0.05) Cumulative Hazard Hip Fracture Adherent Women CaD HR = 0.71 (95% CI, ) P-value = 0.03 Time (years) Hazard Ratio * * p <0.05 Nonusers <500 mg/d 500+ mg/d Baseline Use of Calcium Supplements Calcium/Vitamin D and Fractures: Randomized Trials DIPART Meta-analysis (n=68,500 pts; 7 trials) Any Fracture All Trials 0.95 (0.90, 1.00) Ca+ D Trials 0.92 (0.86, 0.99) D alone Trials 1.01 (0.92, 1.12) Hip Fracture All Trials 0.97 (0.86, 1.10) Ca+ D Trials 0.84 (0.70, 1.01) D alone Trials 1.09 (0.92, 1.29) *No vitamin D dose effect comparing 400 IU and 800 IU.* The DIPART Group. BMJ 2010; 340:b5463. National Osteoporosis Foundation: Meta-Analysis of Calcium/D Studies All Fractures Hip Fractures Source: Weaver CM, et al. Osteoporos Int 2016; 27:

4 Dietary Calcium Intake and Health Outcomes Australian cohort age Recruited years follow-up Dietary Calcium Q1 473 mg/d Q2 686 mg/d Q3 903 mg/d Q mg/d WHI Calcium/D Trial (2006) Primary Endpoints HR (95% CI) Hip fracture 0.88 (0.72,1.08) Adherent 0.71 (0.52,0.97) Secondary Endpoints HR (95% CI) Colorectal cancer 1.08 (0.86,1.34) Breast cancer 0.96 (0.85,1.09) All cancers 0.98 (0.90,1.05) Stroke 0.95 (0.82,1.10) MI or CHD death 1.04 (0.92,1.18) Total mortality 0.91 (0.83,1.01) Source: Khan B, et al. J Bone Miner Res 2015; 30: Effect of Calcium/D on CVD Events: Based on Data from Two RCT of Ca/D and the WHI Ca/D Study Participants Not Taking Personal Calcium Supplements at Baseline What Are Skeletal Health Indicators for Vitamin D? Conceptualization of integrated bone health outcomes and vitamin D exposure Source: Bolland MJ, et al. BMJ 2011:342:d2040. Source: IOM: DRIs for calcium and vitamin D. National Academies Press,

5 Risk Factors for Low Vitamin D Levels Older age Living in the North Avoidance of sun Dark skin pigmentation Obesity Low intake Genetic factors Various medical conditions Vitamin D and Risk of Falling Meta-Analysis Source: Bischoff-Ferrari HA, et al. JAMA 2004;291: % decrease in fall risk Institute of Medicine (IOM) Committee s Conclusion on Vitamin D and CVD, Cancer, and Other Nonskeletal Outcomes Evidence for an association with nonskeletal outcomes is: Inconsistent. Inconclusive as to causality. Not yet sufficient to inform dietary guidelines. Source: IOM: DRIs for Calcium and Vitamin D, National Academies Press, Meta-Analysis of Vitamin D Supplementation and CVD: Secondary Analyses from Randomized Clinical Trials 51 eligible trials: Endpoint HR (95% CI) P-Value Myocardial Infarction 1.02 ( ) 0.64 Stroke 1.05 ( ) 0.59 All-Cause Mortality 0.96 ( ) 0.08 No significant changes in lipids, glucose, BP (systolic or diastolic). Source: Elamin MB, et al. JCEM 2011; 96:

6 Potential Sources of Confounding in the Relationship between Serum 25(OH) Vitamin D and Health Outcomes Poor Nutrition: Low Dietary Intake of Vitamin D Low Sun Exposure Obesity Low 25(OH)D? Low Physical Activity CVD, type 2 diabetes, and cancer Source: Powe CE, et al. N Engl J Med 2013; 369: Vitamin D Potential Indicators for Excess Intake Hypercalcemia; hypercalciuria Emerging evidence for all-cause mortality, cancer, CVD, falls and fractures at high exposures Ongoing Large-Scale Randomized Trials (N 10,000) of Vitamin D Supplementation Worldwide* Trial Sample Age Treatment Vitamin D Primary Location Size+ Range Duration Intervention Endpoints VITamin D and 25, M 5 yrs 2000 IU/d Cancer; OmegA-3 TriaL 55 F (oral) CVD (VITAL) USA D-Health 20, yrs 60,000 IU/ Total Australia month; mortality; (oral) cancer Vitamin D and 20, yrs 100,000 IU/ Total Longevity month (oral) mortality; (VIDAL) UK# cancer *Several moderate-size randomized trials (2,000 - <10,000 participants) also are in progress in the US and worldwide. #In pilot phase. CVD denoted cardiovascular disease. 6

7 The VITamin D and OmegA-3 TriaL (VITAL): Design 25,874 Initially Healthy Men and Women (Men >50 yrs; Women >55 yrs) Vitamin D 3 (2000 IU/d); N=12,937 EPA+DHA (1 gm/d); N=6469 N=6468 EPA+DHA (1 gm/d); N=6468 N=12,937 Mean Treatment Period = 5.0 years 5107 African Americans Blood collection in ~16,953, follow-up bloods in ~6000 Primary Outcomes: Cancer (total) and CVD (MI, stroke, CVD death) Adapted from: Manson JE, Bassuk SS, Lee I-M, et al. Cont Clinical Trials, N=6469 Acknowledgements Jane Cauley, DrPH Nelson Watts, MD Rebecca Jackson, MD Philomena Quinn Researchers, staff, participants in these studies Many others Calcium and Vitamin D Summary Adequate calcium and vitamin D (along with weight-bearing exercise) are necessary for optimal bone health. Total calcium intake of 1200 mg/d is recommended in midlife women; supplementation >1000 mg/d is rarely needed. Vitamin D IU/d is reasonable supplement for most midlife women. For higher-risk patients, measure 25-OH D, with a target blood level 30 ng/dl (75 nmol/l). More is not necessarily better! Thank you! 7

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