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Combined vitamin D, omega-3 fatty acids, and a simple home exercise program may reduce cancer risk among active adults aged 70 and older: a randomized clinical trial |
Bischoff-Ferrari HA, Willett WC, Manson JE, Dawson-Hughes B, Manz MG, Theiler R, Braendle K, Vellas B, Rizzoli R, Kressig RW, Staehelin HB, Da Silva JAP, Armbrecht G, Egli A, Kanis JA, Orav EJ, Gaengler S, DO-HEALTH Research Group |
Frontiers in Aging 2022 Apr 25;3(852643):Epub |
clinical trial |
This trial has not yet been rated. |
OBJECTIVE: The aim of this study was to test the individual and combined benefit of vitamin D, omega-3, and a simple home strength exercise program on the risk of any invasive cancer. DESIGN: The DO-HEALTH trial is a three-year, multicenter, 2 x 2 x 2 factorial design double-blind, randomized-controlled trial to test the individual and combined benefit of three public health interventions. SETTING: The trial was conducted between December 2012 and December 2017 in five European countries. PARTICIPANTS: Generally healthy community-dwelling adults >= 70 years were recruited. Interventions: Supplemental 2000 IU/day of vitamin D3, and/or 1 g/day of marine omega-3s, and/or a simple home strength exercise (SHEP) programme compared to placebo and control exercise. MAIN OUTCOME: In this pre-defined exploratory analysis, time-to-development of any verified invasive cancer was the primary outcome in an adjusted, intent-to-treat analysis. RESULTS: In total, 2,157 participants (mean age 74.9 years; 61.7% women; 40.7% with 25-OH vitamin D below 20 /ml, 83% at least moderately physically active) were randomized. Over a median follow-up of 2.99 years, 81 invasive cancer cases were diagnosed and verified. For the three individual treatments, the adjusted hazard ratios (HRs, 95% CI cases intervention versus control) were 0.76 (0.49 to 1.18; 36 versus 45) for vitamin D3, 0.70 (0.44 to 1.09, 32 versus 49) for omega-3s, and 0.74 (0.48 to 1.15, 35 versus 46) for SHEP. For combinations of two treatments, adjusted HRs were 0.53 (0.28 to 1.00; 15 versus 28 cases) for omega-3s plus vitamin D3; 0.56 (0.30 to 1.04; 11 versus 21) for vitamin D3 plus SHEP; and 0.52 (0.28 to 0.97; 12 versus 26 cases) for omega-3s plus SHEP. For all three treatments combined, the adjusted HR was 0.39 (0.18 to 0.85; 4 versus 12 cases). CONCLUSION: Supplementation with daily high-dose vitamin D3 plus omega-3s, combined with SHEP, showed cumulative reduction in the cancer risk in generally healthy and active and largely vitamin D-replete adults >= 70 years.
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