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What is VITAL? The VITamin D and OmegA-3 TriaL (VITAL) is a research study in 20,000 U.S. men and women investigating whether taking daily dietary supplements of vitamin D (about 2000 IU) or fish oil (about 1 gram of omega-3 fatty acids) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. Recruitment for the study will begin in January 2010.

Effectiveness and safety of vitamin D in relation to bone health. Cranney A, Horsley T, O'Donnell S, Weiler H, Puil L, Ooi D, Atkinson S, Ward L, Moher D, Hanley D, Fang M, Yazdi F, Garritty C, Sampson M, Barrowman N, Tsertsvadze A, Mamaladze V. Evid Rep Technol Assess (Full Rep). 2007 Aug;(158):1-235. Review. PMID: 18088161 CONCLUSIONS: The results highlight the need for additional high quality studies in infants, children, premenopausal women, and diverse racial or ethnic groups. There was fair evidence from studies of an association between circulating 25(OH)D concentrations with some bone health outcomes (established rickets, PTH, falls, BMD). However, the evidence for an association was inconsistent for other outcomes (e.g., BMC in infants and fractures in adults). It was difficult to define specific thresholds of circulating 25(OH)D for optimal bone health due to the imprecision of different 25(OH)D assays. Standard reference preparations are needed so that serum 25(OH)D can be accurately and reliably measured, and validated. In most trials, the effects of vitamin D and calcium could not be separated. Vitamin D(3) (>700 IU/day) with calcium supplementation compared to placebo has a small beneficial effect on BMD, and reduces the risk of fractures and falls although benefit may be confined to specific subgroups. Vitamin D intake above current dietary reference intakes was not reported to be associated with an increased risk of adverse events. However, most trials of higher doses of vitamin D were not adequately designed to assess long-term harms.

Effectiveness and safety of vitamin D in relation to bone health. Cranney A, Horsley T, O'Donnell S, Weiler H, Puil L, Ooi D, Atkinson S, Ward L, Moher D, Hanley D, Fang M, Yazdi F, Garritty C, Sampson M, Barrowman N, Tsertsvadze A, Mamaladze V. Evid Rep Technol Assess (Full Rep). 2007 Aug;(158):1-235. Review. PMID: 18088161 CONCLUSIONS: The results highlight the need for additional high quality studies in infants, children, premenopausal women, and diverse racial or ethnic groups. There was fair evidence from studies of an association between circulating 25(OH)D concentrations with some bone health outcomes (established rickets, PTH, falls, BMD). However, the evidence for an association was inconsistent for other outcomes (e.g., BMC in infants and fractures in adults). It was difficult to define specific thresholds of circulating 25(OH)D for optimal bone health due to the imprecision of different 25(OH)D assays. Standard reference preparations are needed so that serum 25(OH)D can be accurately and reliably measured, and validated. In most trials, the effects of vitamin D and calcium could not be separated. Vitamin D(3) (>700 IU/day) with calcium supplementation compared to placebo has a small beneficial effect on BMD, and reduces the risk of fractures and falls although benefit may be confined to specific subgroups. Vitamin D intake above current dietary reference intakes was not reported to be associated with an increased risk of adverse events. However, most trials of higher doses of vitamin D were not adequately designed to assess long-term harms.

It was observed that in post-menopausal women with documented heart disease from the Estrogen Replacement and Atherosclerosis (ERA) trial, a multicenter clinical trial evaluating the effects of hormone replacement therapy on atherosclerotic progression, in the group consuming the highest-saturated dietary fat diet (12.0% Sat Fat), an enlargement in coronary diameter of 0.01 mm and a 0.1% regression in coronary artery stenosis

The April issue of the journal Cancer Prevention Research published the results of a trial conducted by scientists at Tokyo University of Science, the University of Tsukuba in Japan, and Johns Hopkins University which determined that the isothiocyanate sulforaphane, a compound that occurs in high amounts in broccoli and its sprouts, helps suppress infection by Helicobacter pylori (H. pylori), the bacteria responsible for stomach ulcers and many cases of stomach cancer. The trial is the first to demonstrate an effect for broccoli against H. pylori in humans.

beta-glucan A polysaccharide isolated from the cell walls of bacteria, plants, and fungi with immunostimulant and antineoplastic activities. In a solubilized form, beta-glucan binds to a lectin site within complement receptor 3 (CR3) on leukocytes, priming the receptor to trigger cytotoxic degranulation of leukocytes when leukocyte CR3 binds to complement 3 (iC3b)-coated tumors. Thus, the attachment of beta-glucan to CR3 of circulating leukocytes simulates leukocytes to kill iC3b-coated tumor cells in the same way as they kill iC3b-coated yeast. Check for active clinical trials or closed clinical trials using this agent. (NCI Thesaurus)

Lin PY, Su KP. A meta-analytic review of double-blind, placebo-controlled trials of antidepressant efficacy of omega-3 fatty acids. J Clin Psychiatry. 2007 Jul;68(7):1056-61. PMID: 17685742 [PubMed - in process]

Hallahan B, Hibbeln JR, Davis JM, Garland MR. Omega-3 fatty acid supplementation in patients with recurrent self-harm. Single-centre double-blind randomised controlled trial. Br J Psychiatry. 2007 Feb;190:118-22. PMID: 17267927 [PubMed - indexed for M

Taubert D, Roesen R, Lehmann C, Jung N, Schomig E. Effects of low habitual cocoa intake on blood pressure and bioactive nitric oxide: a randomized controlled trial. JAMA. 2007 Jul 4;298(1):49-60. PMID: 17609490 [PubMed - indexed for MEDLINE]

Lappe JM, Travers-Gustafson D, Davies KM, Recker RR, Heaney RP. Vitamin D and calcium supplementation reduces cancer risk: results of a randomized trial. Am J Clin Nutr. 2007 Jun;85(6):1586-91. PMID: 17556697 [PubMed - indexed for MEDLINE]

"Friday Oct 16, 2009 (foodconsumer.org) -- Results of a new trial presented at an international research conference in Bruges suggest that vitamin D supplementation can reduce the risk of premature births and boost the health of newborn babies, the Times reported Oct 10. Vitamin D deficiency, which is common everywhere, has been linked in many previous studies to a variety of illnesses from heart disease, cancers, multiple sclerosis and many others. In the trial, Dr. Bruce Hollis and Dr. Carol Wagner of the Medical University of South Carolina, Charleston, gave one group of pregnant women 4,000 IUs per day of vitamin D at about three months of pregnancy. They gave a second group 400 IUs per day, amounts recommended by U.S. and UK"

Benefits of Vitamin D Supplementation Joel M. Kauffman, Ph.D. Journal of American Physicians and Surgeons Volume 14 Number 2 - Summer 2009 Clinical trials show that vitamin D supplementation at higher levels than previously recommended is beneficial for many conditions. It decreases the frequency of falls and fractures, helps prevent cardiovascular disease, and reduces symptoms of colds or influenza. Benefits are also seen in diabetes mellitus, multiple sclerosis, Crohn disease, pain, depression, and possibly autism. Sunlight does not cause an overdose of vitamin D production, and toxicity from supplementation is rare. Dose recommendations are increasing, but appear to be lagging the favorable trial results. A number of common drugs deplete vitamin D levels, and others may limit its biosynthesis from sunlight. People with adequate levels from sun exposure will not benefit from supplementation. While dietary intake is helpful, supplementation is better able to raise serum 25-hydroxyvitamin D , the major circulating metabolite, to the level now thought adequate, 30-50 ng/mL. Where there is inadequate daily sun exposure, oral doses of 1,000-2,000 IU/d are now considered routine, with much higher doses (up to 50,000 IU) for rapid repletion now considered safe.

"Largest-ever meta-analysis finds CRP is unlikely to be causal for CVD December 21, 2009 | Lisa Nainggolan Cambridge, UK - In the largest and most comprehensive meta-analysis to date looking at C-reactive-protein (CRP) levels and risk of coronary heart disease (CHD) and stroke, British researchers conclude that CRP is unlikely to be a causal factor for cardiovascular disease [1]. Although CRP concentration was linearly associated with CHD, stroke, and vascular mortality, as well as nonvascular mortality, statistical adjustment for conventional cardiovascular risk factors "resulted in considerable weakening of associations," note the scientists of the Cambridge-based Emerging Risk Factors Collaboration (ERFC), who report their findings online December 21, 2009 in the Lancet. In an editorial accompanying the paper [2], Drs S Matthijs Boekholdt and John JP Kastelein (Academic Medical Center, Amsterdam, the Netherlands) say the UK authors "are to be commended for this impressive data set." Although the findings "add weight to the evidence of noncausality" for a role of CRP in the development of cardiovascular disease, "the debate can be resolved only by randomized trials with agents that specifically target CRP, and such compounds are currently under development," say the Dutch doctors. Commenting on the new meta-analysis for heartwire, Dr Paul Ridker (Brigham and Women's Hospital, Boston, MA), a long-time advocate of CRP and the lead investigator of the JUPITER trial, said: "Whether or not CRP is 'causal' for heart disease is neither the crucial issue at hand nor relevant for public health. What is crucial is getting international agreement that CRP identifies higher-risk individuals who would not otherwise qualify for a life-saving therapy, and then showing that such individuals clearly benefit from treatment. The new meta-analysis demonstrates the former, and JUPITER demonstrates the latter." "

"New research shows a long-term benefit in screening people for CRP, a marker for inflammation, even if they have normal levels of bad cholesterol, because of increased long-term risk for heart attack, stroke and death. These findings, which will be published online today in the Journal of the American College of Cardiology (JACC), demonstrate that a very simple screening, age plus CRP, can identify individuals who may benefit from statin therapy. "This study builds on results from the landmark JUPITER trial, which showed that statins can prevent heart disease in people with normal LDL-c, or bad cholesterol, and an increased level of CRP," said Dr. Christie Ballantyne, director of the Center for Cardiovascular Disease Prevention at the Methodist DeBakey Heart & Vascular Center and last author on the study. "We have demonstrated that the cardiovascular disease event rates persist over time, validating that the risks identified in the JUPITER trial persist for nearly seven year"

"Vytorin has struck out again, this time in a clinical trial that compared the drug's safety and efficacy to a prescription form of the B vitamin niacin. The results of the trial, which the New England Journal of Medicine featured in an article and two editorials, were presented Sunday at an American Heart Association meeting and showed that in a direct comparison, niacin worked significantly better than Vytorin and Zetia in reducing arterial blockages. According to a report in NPR, "This study is the third to question whether ezetimibe drugs do what they're supposed to." If lowering LDL or "bad" cholesterol is the doctor's sole intention when prescribing Vytorin to patients, then the drug does a great job. However, as previous studies have shown, lower levels of LDL cholesterol don't automatically translate to cleaner arteries and lower incidences of cardiac arrest. While Vytorin worked better than statins combined with time-release Niacin to lower LDL cholesterol in 200 patients, its performance was inferior in reducing artery clogging deposits."

n-3 fatty acids and cardiovascular disease. Breslow JL. Am J Clin Nutr. 2006 Jun;83(6 Suppl):1477S-1482S. Review. PMID: 16841857 The results of prospective cohort studies indicate that consuming fish or fish oil containing the n-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) is associated with decreased cardiovascular death, whereas consumption of the vegetable oil-derived n-3 fatty acid {alpha}-linolenic acid is not as effective. Randomized control trials (RCTs) in the context of secondary prevention also indicate that the consumption of EPA plus DHA is protective at doses 3 g/d, EPA plus DHA can improve cardiovascular disease risk factors, including decreasing plasma triacylglycerols, blood pressure, platelet aggregation, and inflammation, while improving vascular reactivity. Mainly on the basis of the results of RCTs, the American Heart Association recommends that everyone eat oily fish twice per week and that those with coronary heart disease eat 1 g/d of EPA plus DHA from oily fish or supplements. Directions for future research include 1) RCTs to confirm the initial trials showing that EPA plus DHA decreases cardiovascular death and additional studies to determine whether this effect is due to EPA, DHA, or the combination; the dosage of the effective components; and whether the mechanism of action in humans is prevention of fatal arrhythmias. 2) Clinical studies to determine whether the reduction in cardiovascular disease risk factors is due to EPA, DHA, or the combination and the dosage of the effective components. 3) Clinical studies to determine whether vegetable oil-derived {alpha}-linolenic acid added to a diet enriched in n-6 fatty acids can effectively substitute for fish oil-derived EPA plus DHA.

Serum vitamin D concentration and prostate cancer risk: a nested case-control study. Ahn J, Peters U, Albanes D, Purdue MP, Abnet CC, Chatterjee N, Horst RL, Hollis BW, Huang WY, Shikany JM, Hayes RB; Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial Project Team. J Natl Cancer Inst. 2008 Jun 4;100(11):796-804. Epub 2008 May 27. PMID: 18505967 doi:10.1093/jnci/djn152 CONCLUSION: The findings of this large prospective study do not support the hypothesis that vitamin D is associated with decreased risk of prostate cancer; indeed, higher circulating 25(OH)D concentrations may be associated with increased risk of aggressive disease. In summary, results from this large prospective study of men who underwent standardized prostate cancer screening in the context of a screening Trial do not support the hypothesis that higher serum vitamin D status is associated with decreased risk of prostate cancer. The study showed no association of vitamin D level with nonaggressive disease; however, it raises the possibility that higher vitamin D level may be associated with increased risks for aggressive disease, although a clear monotonic dose-response relationship was lacking. Along with recent reports of adverse associations for higher vitamin D status and risk of pancreatic (32) and esophageal (33,34) cancer, caution should be taken in recommending high doses of vitamin D or sunlight exposure to the general public for prostate cancer prevention. Future analyses are warranted to confirm these results and to further clarify the effects of vitamin D on aggressive prostate cancer.

"Wednesday, May 27, 2009 Eicosanoids and Ischemic Heart Disease, Part II Here's where it gets more complicated and more interesting. The ratio of omega-6 to omega-3 matters, but so does the total amount of each. This is a graph from a 1992 paper by Dr. Lands: In sum, this suggests that the single best way to avoid a heart attack is to reduce omega-6 consumption and ensure an adequate source of omega-3. The lower the omega-6, the less the omega-3 matters. This is a nice theory, but where's the direct evidence? In the next post, I'll discuss the controlled trial that proved this concept once and for all: the Lyon diet-heart trial.

A phase 2 trial exploring the effects of high-dose (10,000 IU/day) vitamin D(3) in breast cancer patients with bone metastases. Amir E, Simmons CE, Freedman OC, Dranitsaris G, Cole DE, Vieth R, Ooi WS, Clemons M. Cancer. 2009 Nov 13. [Epub ahead of print] PMID: 19918922 DOI: 10.1002/cncr.24749 METHODS: Patients with bone metastases treated with bisphosphonates were enrolled into this single-arm phase 2 study. Patients received 10,000 IU of vitamin D3 and 1000 mg of calcium supplementation each day for 4 months. The effect of this treatment on palliation, bone resorption markers, calcium metabolism, and toxicity were evaluated at baseline and monthly thereafter. CONCLUSIONS: Daily doses of 10,000 IU vitamin D3 for 4 months appear safe in patients without comorbid conditions causing hypersensitivity to vitamin D. Treatment reduced inappropriately elevated parathyroid hormone levels, presumably caused by long-term bisphosphonate use. There did not appear to be a significant palliative benefit nor any significant change in bone resorption. Cancer 2010. © 2009 American Cancer Society.

"Berberine is a bitter-tasting, yellow, plant alkaloid with a long history of medicinal use in Chinese and Ayurvedic medicine. Berberine is present in the roots, rhizomes and stem bark of various plants including Hydrastis canadensis (goldenseal), Coptis chinensis (coptis or goldenthread), Berberis aquifolium (Oregon grape), Berberis vulgaris (barberry), and Berberis aristata (tree turmeric). Berberine has also been used historically as a dye, due to its yellow color. Clinical trials have been conducted using berberine. There is some evidence to support its use in the treatment of trachomas (eye infections), bacterial diarrhea, and leishmaniasis (parasitic disease). Berberine has also shown antimicrobial activity against bacteria, viruses, fungi, protozoans, helminths (worms), and chlamydia (STD). Future clinical research is warranted in these areas, as well as cardiovascular disease, skin disorders, and liver disorders. Berberine has been shown to be safe in the majority of clinical trials. However, there is a potential for interaction between berberine and many prescription medications, and berberine should not be used by pregnant or breastfeeding women, due to potential for adverse effects in the newborn."