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Adverse events associated with dietary supplements: An observational study

https://arctichealth.org/en/permalink/ahliterature31168
Source
Lancet. 2003 Jan 11;361(9352):101-6
Publication Type
Article
Date
Jan-11-2003
Author
Palmer, ME
Haller, C
McKinney, PE
Klein-Schwartz, W
Tschirgi, A
Smolinske, SC
Woolf, A
Sprague, BM
Ko, R
Everson, G
Nelson. LS
Dodd-Butera, T
Bartlett, WD
Landzberg, BR
Author Affiliation
Department of Emergency Medicine, Landspitali University Hospital, Fossvogi, 108, Reykjavík, Iceland. mpalmer@landspitali.is
Source
Lancet. 2003 Jan 11;361(9352):101-6
Date
Jan-11-2003
Language
English
Publication Type
Article
Keywords
Adolescent
Adult
Aged
Animals
Child
Child, Preschool
Dietary Supplements - adverse effects
Humans
Infant
Middle Aged
Poison Control Centers - statistics & numerical data
Research Support, U.S. Gov't, P.H.S.
Severity of Illness Index
United States - epidemiology
Abstract
BACKGROUND: Adverse events associated with dietary supplements are difficult to monitor in the USA, because such products are not registered before sale, and there is little information about their content and safety. METHODS: In 1998, 11 poison control centres in the USA recorded details of 2332 telephone calls about 1466 ingestions of dietary supplements, in 784 of which patients had symptoms. We used a multitiered review process (kappa 0.42) to select 489 cases for whom we were at least 50% certain that their negative events were associated with dietary supplements. We aimed to assess the effects of multiple ingredients and long-term use, and collated data for patterns of use and information resources. FINDINGS: A third of events were of greater than mild severity. We noted both new and previously reported associations that included myocardial infarction, liver failure, bleeding, seizures, and death. Increased symptom severity was associated with use of several ingredients, long-term use, and age. Paediatric exposures were more often unintentional than were adult ingestions, and treatment of disease was the reason for supplement use in at least 28% of reports. Most products and ingredients were not identified in the information database (Poisindex) used by poison control centres, and specific adverse events were reported variably among five additional sources. INTERPRETATION: Dietary supplements are associated with adverse events that include all levels of severity, organ systems, and age groups. Associations between adverse events and ingredients are difficult to verify if a product has more than one ingredient, and because of incomplete information systems. Research into hazards and risks of dietary supplements should be a priority.
Notes
Comment In: Lancet. 2003 May 3;361(9368):156612737905
PubMed ID
12531576 View in PubMed
Less detail
Source
Ugeskr Laeger. 2006 Aug 21;168(34):2787-9
Publication Type
Article
Date
Aug-21-2006
Author
Skibsted Leif H
Dragsted Lars O
Dyerberg Jørn
Hansen Harald S
Kiens Bente
Ovesen Lars F
Tjønneland Anne M
Author Affiliation
Motions- og Ernaeringsrådets, Søborg. sm@meraadet.dk
Source
Ugeskr Laeger. 2006 Aug 21;168(34):2787-9
Date
Aug-21-2006
Language
Danish
Publication Type
Article
Keywords
Animals
Antioxidants - administration & dosage - adverse effects
Ascorbic Acid - administration & dosage - adverse effects
Denmark
Dietary Supplements - adverse effects
Evidence-Based Medicine
Food Habits
Fruit
Health status
Humans
Nutrition Policy
Oxidative Stress
Risk factors
Vegetables
Vitamin E - administration & dosage - adverse effects
Abstract
The Danish Fitness and Nutrition Council has evaluated the basis for recommendations on the intake of antioxidants and has found limited basis for increasing the recommended intake levels for the antioxidants vitamin C and E. Evidence was insufficient to support recommendations for polyphenol or carotenoid supplementation. Supplementation with high doses of vitamin E and beta-carotene may present a health risk. A high intake of fruit and vegetables is associated with a reduced risk of lifestyle diseases, but there is no evidence that this association is due to an antioxidant effect.
Notes
Comment In: Ugeskr Laeger. 2006 Oct 9;168(41):3537; author reply 353717066533
PubMed ID
16942696 View in PubMed
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Ascorbic acid supplements and kidney stone incidence among men: a prospective study.

https://arctichealth.org/en/permalink/ahliterature116587
Source
JAMA Intern Med. 2013 Mar 11;173(5):386-8
Publication Type
Article
Date
Mar-11-2013
Author
Laura D K Thomas
Carl-Gustaf Elinder
Hans-Göran Tiselius
Alicja Wolk
Agneta Akesson
Source
JAMA Intern Med. 2013 Mar 11;173(5):386-8
Date
Mar-11-2013
Language
English
Publication Type
Article
Keywords
Aged
Ascorbic Acid - administration & dosage - adverse effects - pharmacokinetics
Calcium Oxalate - metabolism
Cohort Studies
Dietary Supplements - adverse effects
Dose-Response Relationship, Drug
Humans
Incidence
Kidney Calculi - chemically induced - epidemiology - metabolism
Male
Middle Aged
Proportional Hazards Models
Prospective Studies
Risk assessment
Sweden
Vitamins - administration & dosage - adverse effects - pharmacokinetics
Notes
Comment In: JAMA Intern Med. 2013 Jul 22;173(14):138423877084
Comment In: JAMA Intern Med. 2013 Jul 22;173(14):138423877085
Comment In: Nat Rev Urol. 2013 Apr;10(4):18423419496
Comment In: JAMA Intern Med. 2013 Mar 11;173(5):375-9423381657
Comment In: J Urol. 2013 Oct;190(4):1268-924029326
Comment In: Nat Rev Nephrol. 2013 Apr;9(4):18723419349
PubMed ID
23381591 View in PubMed
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Availability of weight-loss supplements: Results of an audit of retail outlets in a southeastern city.

https://arctichealth.org/en/permalink/ahliterature83377
Source
J Am Diet Assoc. 2006 Dec;106(12):2045-51
Publication Type
Article
Date
Dec-2006
Author
Sharpe Patricia A
Granner Michelle L
Conway Joan M
Ainsworth Barbara E
Dobre Mirela
Author Affiliation
Prevention Research Center, Arnold School of Public Health, University of South Carolina, 921 Assembly St, Columbia, SC 29208, USA. pasharpe@sc.edu
Source
J Am Diet Assoc. 2006 Dec;106(12):2045-51
Date
Dec-2006
Language
English
Publication Type
Article
Keywords
Anti-Obesity Agents - adverse effects - analysis - supply & distribution - therapeutic use
Commerce
Dietary Supplements - adverse effects - analysis - supply & distribution - utilization
Evidence-Based Medicine
Humans
Obesity - drug therapy
Phytotherapy
Plant Preparations - therapeutic use
Risk assessment
Safety
South Carolina
Treatment Outcome
Weight Loss - drug effects
Abstract
The sale of nonprescription weight-loss products accounts for millions of dollars spent by Americans trying to lose weight, yet there is little evidence for effectiveness and there are multiple safety concerns. The purpose of this study was to determine what products, and ingredients within products, were available at retail outlets in a metropolitan area. A purposive sampling strategy identified 73 retail outlets. An audit form was used to collect information from product labels. The audit identified 402 products containing 4,053 separate ingredients. The mean number of ingredients per product was 9.9+/-8.96 (range = 1 to 96). A database search was conducted regarding evidence for effectiveness, safety precautions, and side effects for the 10 ingredients that appeared most often across products. Modest evidence of effectiveness exists for green tea (Camellia sinensis), chromium picolinate, and ma huang (Ephedra major). For the remaining seven (ginger root [Zingiber officinale], guarana [Paullinia cupana], hydroxycitric acid [Garcinia cambogia], white willow [Salix alba], Siberian ginseng [Eleutherococcus senticosus], cayenne [Capsicum annuum], and bitter orange/zhi shi [Citrus aurantium]), inadequate or negative evidence exists. Although precautions and contraindications were found for all 10 ingredients, the strongest concerns in the literature appear for ma huang, bitter orange, and guarana. Our audit revealed numerous weight-loss products available to consumers, yet there is little evidence to support the effectiveness of the top 10 ingredients identified and many potential adverse reactions; therefore, food and nutrition professionals should discuss dietary supplement use with their clients.
PubMed ID
17126636 View in PubMed
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Baseline selenium status and effects of selenium and vitamin e supplementation on prostate cancer risk.

https://arctichealth.org/en/permalink/ahliterature104917
Source
J Natl Cancer Inst. 2014 Mar;106(3):djt456
Publication Type
Article
Date
Mar-2014
Author
Alan R Kristal
Amy K Darke
J Steven Morris
Catherine M Tangen
Phyllis J Goodman
Ian M Thompson
Frank L Meyskens
Gary E Goodman
Lori M Minasian
Howard L Parnes
Scott M Lippman
Eric A Klein
Author Affiliation
Affiliations of authors: Cancer Prevention Program (ARK) and SWOG Statistical Center (AKD, CMT, PJG), Fred Hutchinson Cancer Research Center, Seattle, WA; Department of Epidemiology (ARK, GEG) and Department of Environmental Health (GEG), University of Washington, Seattle, WA; University of Missouri, Research Reactor Center, Columbia, MO (JSM); Harry S. Truman Memorial Veterans Hospital, Columbia, MO (JSM); Department of Urology, University of Texas Health Science Center at San Antonio, San Antonio, TX (IMT); Chao Family Comprehensive Cancer Center, University of California Irvine, Irvine, CA (FLM); Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Bethesda, MD (LMM, HLP); Moores Cancer Center, University of California San Diego, San Diego, CA (SML); Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, OH (EAK).
Source
J Natl Cancer Inst. 2014 Mar;106(3):djt456
Date
Mar-2014
Language
English
Publication Type
Article
Keywords
African Americans - statistics & numerical data
Aged
Antioxidants - administration & dosage - adverse effects - analysis
Canada - epidemiology
Cohort Studies
Dietary Supplements - adverse effects
Humans
Male
Middle Aged
Nails - chemistry
Neoplasm Grading
Odds Ratio
Proportional Hazards Models
Prostatic Neoplasms - chemically induced - epidemiology - pathology
Puerto Rico - epidemiology
Randomized Controlled Trials as Topic
Risk
Selenium - administration & dosage - adverse effects - analysis
Trace Elements - adverse effects
United States - epidemiology
Vitamin E - administration & dosage - adverse effects - analysis
Vitamins - adverse effects
Abstract
The Selenium and Vitamin E Cancer Prevention Trial found no effect of selenium supplementation on prostate cancer (PCa) risk but a 17% increased risk from vitamin E supplementation. This case-cohort study investigates effects of selenium and vitamin E supplementation conditional upon baseline selenium status.
There were 1739 total and 489 high-grade (Gleason 7-10) PCa cases and 3117 men in the randomly selected cohort. Proportional hazards models estimated hazard ratios (HRs) and 95% confidence intervals (CIs) for effects of supplementation within quintiles of baseline toenail selenium. Cox proportional hazards models were used to estimate hazard ratios, and all statistical tests are two-sided.
Toenail selenium, in the absence of supplementation, was not associated with PCa risk. Selenium supplementation (combined selenium only and selenium + vitamin E arms) had no effect among men with low selenium status (
Notes
Comment In: J Natl Cancer Inst. 2014 Mar;106(3):dju00524563520
Comment In: Nat Rev Urol. 2014 Apr;11(4):18424619375
PubMed ID
24563519 View in PubMed
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Calcium and vitamin D intake and mortality: results from the Canadian Multicentre Osteoporosis Study (CaMos).

https://arctichealth.org/en/permalink/ahliterature113637
Source
J Clin Endocrinol Metab. 2013 Jul;98(7):3010-8
Publication Type
Article
Date
Jul-2013
Author
Lisa Langsetmo
Claudie Berger
Nancy Kreiger
Christopher S Kovacs
David A Hanley
Sophie A Jamal
Susan J Whiting
Jacques Genest
Suzanne N Morin
Anthony Hodsman
Jerilynn C Prior
Brian Lentle
Millan S Patel
Jacques P Brown
Tassos Anastasiades
Tanveer Towheed
Robert G Josse
Alexandra Papaioannou
Jonathan D Adachi
William D Leslie
K Shawn Davison
David Goltzman
Source
J Clin Endocrinol Metab. 2013 Jul;98(7):3010-8
Date
Jul-2013
Language
English
Publication Type
Article
Keywords
Adult
Aged
Aged, 80 and over
Calcium, Dietary - administration & dosage - adverse effects
Canada - epidemiology
Cohort Studies
Diet - adverse effects
Dietary Supplements - adverse effects
Female
Follow-Up Studies
Health Surveys
Humans
Longitudinal Studies
Male
Middle Aged
Mortality
Proportional Hazards Models
Prospective Studies
Sex Characteristics
Vitamin D - administration & dosage - adverse effects
Abstract
Calcium and vitamin D are recommended for bone health, but there are concerns about adverse risks. Some clinical studies suggest that calcium intake may be cardioprotective, whereas others report increased risk associated with calcium supplements. Both low and high serum levels of 25-hydroxyvitamin D have been associated with increased mortality.
The purpose of this study was to determine the association between total calcium and vitamin D intake and mortality and heterogeneity by source of intake.
The Canadian Multicentre Osteoporosis Study cohort is a population-based longitudinal cohort with a 10-year follow-up (1995-2007).
This study included randomly selected community-dwelling men and women.
A total of 9033 participants with nonmissing calcium and vitamin D intake data and follow-up were studied.
Total calcium intake (dairy, nondairy food, and supplements) and total vitamin D intake (milk, yogurt, and supplements) were recorded.
The outcome variable was all-cause mortality.
There were 1160 deaths during the 10-year period. For women only, we found a possible benefit of higher total calcium intake, with a hazard ratio of 0.95 (95% confidence interval, 0.89-1.01) per 500-mg increase in daily calcium intake and no evidence of heterogeneity by source; use of calcium supplements was also associated with reduced mortality, with hazard ratio of 0.78 (95% confidence interval, 0.66-0.92) for users vs nonusers with statistically significant reductions remaining among those with doses up to 1000 mg/d. These associations were not modified by levels of concurrent vitamin D intake. No definitive associations were found among men.
Calcium supplements, up to 1000 mg/d, and increased dietary intake of calcium may be associated with reduced risk of mortality in women. We found no evidence of mortality benefit or harm associated with vitamin D intake.
PubMed ID
23703722 View in PubMed
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Clinical safety evaluation of marine oil derived from Calanus finmarchicus.

https://arctichealth.org/en/permalink/ahliterature280834
Source
Regul Toxicol Pharmacol. 2016 Oct;80:25-31
Publication Type
Article
Date
Oct-2016
Author
Kurt S Tande
Trung D Vo
Barry S Lynch
Source
Regul Toxicol Pharmacol. 2016 Oct;80:25-31
Date
Oct-2016
Language
English
Publication Type
Article
Keywords
Administration, Oral
Adult
Aged
Animals
Capsules
Copepoda - chemistry
Dietary Supplements - adverse effects
Double-Blind Method
Esters - administration & dosage - adverse effects - isolation & purification - therapeutic use
Fatty Acids, Unsaturated - administration & dosage - adverse effects - isolation & purification - therapeutic use
Female
Glucose Tolerance Test
Humans
Male
Middle Aged
Norway
Patient Safety
Risk assessment
Surveys and Questionnaires
Time Factors
Treatment Outcome
Waxes - adverse effects - isolation & purification - therapeutic use
Young Adult
Abstract
Marine oils are rich in polyunsaturated fatty acids (PUFAs), including docosahexaenoic and eicosapentaenoic acid. These PUFAs are associated with health benefits and additional sustainable sources of marine oils are desirable. One of the source organisms is Calanus finmarchicus, a copepod endemic to the North Atlantic. PUFAs in the lipid fraction of this organism are largely in the form of wax esters. To assess the safety of these wax esters as a source of PUFAs, a randomized, double-blinded, placebo-controlled clinical trial was conducted whereby 64 subjects consumed 2 g Calanus oil in capsule form daily for a period of one year. A group of 53 subjects consumed placebo capsules. At baseline, 6-, and 12-months, series of evaluations were conducted, including: vital signs, clinical chemistry and hematological evaluations, and adverse event reporting. Food intake and physical exercise were controlled by means of a questionnaire. There were no effects on Calanus oil treatment on any of the safety parameters measured. A slight increase in the incidence of eczema was reported in the Calanus oil group, but the response was minor in nature, not statistically significant after controlling for multiple comparisons, and could not be attributed to treatment.
PubMed ID
27233921 View in PubMed
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Cod liver oil intake and incidence of asthma in Norwegian adults--the HUNT study.

https://arctichealth.org/en/permalink/ahliterature120716
Source
Thorax. 2013 Jan;68(1):25-30
Publication Type
Article
Date
Jan-2013
Author
Xiao-Mei Mai
Arnulf Langhammer
Yue Chen
Carlos A Camargo
Author Affiliation
Department of Public Health and General Practice, Norwegian University of Science and Technology, Trondheim, Norway. xiao-mei.mai@ntnu.no
Source
Thorax. 2013 Jan;68(1):25-30
Date
Jan-2013
Language
English
Publication Type
Article
Keywords
Adult
Age Distribution
Asthma - epidemiology - etiology - physiopathology
Cod Liver Oil - administration & dosage - adverse effects
Cross-Sectional Studies
Dietary Supplements - adverse effects
Dose-Response Relationship, Drug
Drug Administration Schedule
Female
Humans
Incidence
Logistic Models
Male
Multivariate Analysis
Norway - epidemiology
Odds Ratio
Questionnaires
Reference Values
Risk assessment
Sex Distribution
Vitamin A - administration & dosage - adverse effects
Young Adult
Abstract
Cod liver oil is an important source of vitamin D, but also contains other fat-soluble components such as vitamin A. Before 1999, the cod liver oil formula in Norway contained a high concentration of vitamin A (1000 µg per 5 ml). High vitamin A status is associated with increased risks of several chronic diseases.
To investigate the association between cod liver oil intake and asthma development.
In the Nord-Trøndelag Health Study, a total of 25 616 Norwegian adults aged 19-55 years were followed up from 1995-1997 to 2006-2008. Current analysis based on 17 528 subjects who were free of asthma and had complete information on cod liver oil intake at baseline. Cod liver oil intake was defined as daily intake = 1 month during the year prior to baseline. Incident asthma was reported as new-onset asthma during the 11-year follow-up.
Of the 17 528 subjects, 18% (n=3076) consumed cod liver oil daily for = 1 month over the past year. Cod liver oil intake was significantly associated with incident asthma with an OR of 1.62 (95% CI 1.32 to 1.98) after adjustment for age, sex, daily smoking, physical activity, education, socio-economic status, family history of asthma, and body mass index (BMI). The positive association was consistent across age (
PubMed ID
22977130 View in PubMed
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A comparison of micronutrient inadequacy and risk of high micronutrient intakes among vitamin and mineral supplement users and nonusers in Canada.

https://arctichealth.org/en/permalink/ahliterature127396
Source
J Nutr. 2012 Mar;142(3):534-40
Publication Type
Article
Date
Mar-2012
Author
Yaseer A Shakur
Valerie Tarasuk
Paul Corey
Deborah L O'Connor
Author Affiliation
Department of Nutritional Sciences, University of Toronto, Canada.
Source
J Nutr. 2012 Mar;142(3):534-40
Date
Mar-2012
Language
English
Publication Type
Article
Keywords
Adolescent
Adult
Aged
Canada
Child
Child, Preschool
Cross-Sectional Studies
Dietary Supplements - adverse effects
Eating
Female
Humans
Infant
Male
Micronutrients - administration & dosage - adverse effects - deficiency
Middle Aged
Nutrition Surveys
Nutritional Status
Young Adult
Abstract
Although supplement use is prevalent in North America, there is little information on how supplements affect the prevalence of nutrient adequacy or risk of intakes greater than the tolerable upper intake level (UL). The objectives of this study were to compare the prevalence of nutrient adequacy and percent of intakes greater than the UL from diet alone between supplement users and nonusers and determine the contribution of supplements to nutrient intakes. Dietary intakes (24-h recall) and supplement use (previous 30 d) from respondents =1 y in the Canadian Community Health Survey 2.2 (n = 34,381) were used to estimate the prevalence of nutrient adequacy and intakes greater than the UL. Software for Intake Distribution Evaluation was used to estimate usual intakes. The prevalence of nutrient adequacy from diet alone was not significantly higher among supplement users than nonusers for any nutrient. Based on diet alone, children 1-13 y had a low prevalence of nutrient adequacy (30%. For other nutrients, there was a low prevalence of nutrient adequacy. There were no nutrient intakes greater than the UL from diet alone, except zinc in children. When supplements were included, =10% of users in some age/sex groups had intakes of vitamins A and C, niacin, folic acid, iron, zinc, and magnesium greater than the UL, reaching >80% for vitamin A and niacin in children. In conclusion, from diet alone, the prevalence of nutrient adequacy was low for most nutrients except for calcium, magnesium, and vitamins A and D. For most nutrients, supplement users were not at greater risk of inadequacy than nonusers; supplement use sometimes led to intakes greater than the UL.
PubMed ID
22298574 View in PubMed
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A comparison of the prevalence of fluorosis in 8-year-old children from seven European study sites using a standardized methodology.

https://arctichealth.org/en/permalink/ahliterature30463
Source
Community Dent Oral Epidemiol. 2004 Apr;32 Suppl 1:28-33
Publication Type
Article
Date
Apr-2004
Author
Judith A Cochran
Clare E Ketley
Inga B Arnadóttir
Barros Fernandes
Haroula Koletsi-Kounari
Anna-Maria Oila
Cor van Loveren
Helen P Whelton
Denis M O'Mullane
Author Affiliation
Oral Health Services Research Centre, University College Cork, Ireland.
Source
Community Dent Oral Epidemiol. 2004 Apr;32 Suppl 1:28-33
Date
Apr-2004
Language
English
Publication Type
Article
Keywords
Cariostatic Agents - adverse effects
Child
Comparative Study
Dietary Supplements - adverse effects
England - epidemiology
Finland - epidemiology
Fluoridation - adverse effects
Fluorides - adverse effects
Fluorosis, Dental - epidemiology - etiology
Greece - epidemiology
Humans
Iceland - epidemiology
Incisor
Ireland - epidemiology
Maxilla
Netherlands - epidemiology
Photography, Dental - standards
Portugal - epidemiology
Prevalence
Sampling Studies
Abstract
OBJECTIVES: The objectives of this study were to report on the prevalence of enamel opacities from seven European study sites using a standardized photographic method, and to investigate the importance of variables responsible for enamel fluorosis. METHODS: The sample comprised a randomly selected group of 300 8-year-old children in each of the study areas. One examiner from each area was trained and calibrated in the use of a standardized photographic technique. Two transparencies were taken of each child's permanent maxillary central incisor teeth; one to represent the teeth 'wet' and one when the teeth had been allowed to dry out naturally for 105 s. The transparencies were viewed 'blind' by the author (JAC) and scored using the DDE and TF indices. Data relating to variables considered to be associated with enamel fluorosis were also collected. RESULTS: The prevalence of diffuse opacities ranged from 61% in fluoridated Cork (Ireland) to 28% in Athens (Greece). The percentage of subjects with a TF score of three or more ranged from 4% in Cork and nonfluoridated Haarlem (the Netherlands) to zero in Oulu (Finland) and Athens. Fluoridated water and the prolonged use of fluoride tablets were found to be significant contributory factors to fluorosis. CONCLUSIONS: The prevalence of fluorosis was found to be highest in fluoridated Cork. The prolonged use of fluoride supplements was also found to be a significant risk indicator associated with fluorosis.
PubMed ID
15016114 View in PubMed
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59 records – page 1 of 6.