Cost-Effectiveness and Estimated Health Benefits of Treating Patients with Vitamin D in Pre-Dialysis.

Background The optimal timing of treatment with vitamin D therapy for patients with chronic kidney disease (CKD), vitamin D insufficiency, and secondary hyperparathyroidism (SHPT) is a pressing question in nephrology with economic and patient outcome implications. Objective The objective of this study was to estimate the cost-effectiveness of earlier vitamin D treatment in CKD patients not on dialysis with vitamin D insufficiency and SHPT. Design A cost-effectiveness analysis based on a Markov model of CKD progression was developed from the Medicare perspective. The model follows a hypothetical cohort of 1000 Stage 3 or 4 CKD patients over a 5-year time horizon. The intervention was vitamin D therapy initiated in CKD stages 3 or 4 through CKD stage 5/end-stage renal disease (ESRD) versus initiation in CKD stage 5/ESRD only. The outcomes of interest were cardiovascular (CV) events averted, fractures averted, time in CKD stage 5/ESRD, mortality, quality-adjusted life years (QALYs), and costs associated with clinical events and CKD stage. Results Vitamin D treatment in CKD stages 3 and 4 was a dominant strategy when compared to waiting to treat until CKD stage 5/ESRD. Total cost savings associated with treatment during CKD stages 3 and 4, compared to waiting until CKD stage 5/ESRD, was estimated to be $19.9 million. The model estimated that early treatment results in 159 averted CV events, 5 averted fractures, 269 fewer patient-years in CKD stage 5, 41 fewer deaths, and 191 additional QALYs. Conclusions Initiating vitamin D therapy in CKD stages 3 or 4 appears to be cost-effective, largely driven by the annual costs of care by CKD stage, CV event costs, and risks of hypercalcemia. Further research demonstrating causal relationships between vitamin D therapy and patient outcomes is needed to inform decision making regarding vitamin D therapy timing.

Assessing Vitamins, Minerals and Supplements Marketed to Children in Canada.

Given the growth of supplements specifically designed for children in Canada, this study examines the nutrient levels of these products, and evaluates them in light of the US Health and Medical Division (HMD)-formerly the Institute of Medicine-and Health Canada's recommendations. Content analysis was used to document the nutrient levels of child-targeted vitamins, minerals and fish oils/omega-3s (n = 80) in Calgary, Alberta, Canada. Products were assessed according to HMD and Health Canada dosage recommendations for children, and the percentage of Estimate Average Requirements (EAR), Adequate Intakes (AI), and Tolerable Upper Intakes Level (UL) calculated. Median EAR/AI/UL percentages and quartiles were calculated for each nutrient, and estimates for the adequate intake recommendations plotted with box plots. Sixty five percent of the products assessed were multivitamins; the median dose was higher than AI recommendations for vitamins A, B6, B12, and C, as well as thiamin, riboflavin, pantothenic acid, and biotin. Substantial variation in vitamin, mineral, or fish oil dosage was found between similar supplements-with nutrients such as vitamin B12 ranging from 83% to 5557% of AI. Such findings matter because the very existence of these products suggests that children should be taking them, yet more research is needed on their potential (adverse) effects over both the short and long term. The substantial variation in dosages between products also raises questions about the (perhaps unnecessary) fortification of our children, as well as the expectations that parents know-or are even aware of-appropriate nutrient levels for their kids.

Effect of Vitamin K2 on Postural Sway in Older People Who Fall: A Randomized Controlled Trial.

OBJECTIVES: Vitamin K is thought to be involved in both bone health and maintenance of neuromuscular function. We tested the effect of vitamin K2 supplementation on postural sway, falls, healthcare costs, and indices of physical function in older people at risk of falls. DESIGN: Parallel-group double-blind randomized placebo-controlled trial. SETTING: Fourteen primary care practices in Scotland, UK. PARTICIPANTS: A total of 95 community-dwelling participants aged 65 and older with at least two falls, or one injurious fall, in the previous year. INTERVENTION: Once/day placebo, 200 µg or 400 µg of oral vitamin K2 for 1 year. MEASUREMENTS: The primary outcome was anteroposterior sway measured using sway plates at 12 months, adjusted for baseline. Secondary outcomes included the Short Physical Performance Battery, Berg Balance Scale, Timed Up & Go Test, quality of life, health and social care costs, falls, and adverse events. RESULTS: Mean participant age was 75 (standard deviation [SD] = 7) years. Overall, 58 of 95 (61%) were female; 77 of 95 (81%) attended the 12-month visit. No significant effect of either vitamin K2 dose was seen on the primary outcome of anteroposterior sway (200 µg vs placebo: -.19 cm [95% confidence interval [CI] -.68 to .30; P = .44]; 400 µg vs placebo: .17 cm [95% CI -.33 to .66; P = .50]; or 400 µg vs 200 µg: .36 cm [95% CI -.11 to .83; P = .14]). Adjusted falls rates were similar in each group. No significant treatment effects were seen for other measures of sway or secondary outcomes. Costs were higher in both vitamin K2 arms than in the placebo arm. CONCLUSION: Oral vitamin K2 supplementation did not improve postural sway or physical function in older people at risk of falls. J Am Geriatr Soc 67:2102-2107, 2019.

Adequate Multivitamin Supplementation after Roux-En-Y Gastric Bypass Results in a Decrease of National Health Care Costs: a Cost-Effectiveness Analysis.

INTRODUCTION: Patients with morbid obesity undergoing metabolic surgery are prone to develop vitamin and mineral deficiencies, which may worsen in time. In order to prevent these deficiencies after metabolic surgery, all patients are advised to take daily multivitamin supplementation. The aim of the study was to assess the cost-effectiveness of specially developed multivitamins (WLS Forte®) for metabolic surgery and over-the-counter (standard) multivitamin supplementation (sMVS). METHODS: This cost-effectiveness analysis was preformed alongside an RCT for the Netherlands. Between June 2011 and March 2012, a total of 148 patients were randomized to one tablet daily of either WLS Forte® or sMVS. The patients were followed for 12 months. Data on costs within the health sector and outside the health sector were collected. The primary outcome is financial and logistic advantages, in terms of less patient visits to the outpatient department and the relevant costs to the employer due to absenteeism. RESULTS: In total, 10 (14%) patients in the WLS Forte® group versus 23 (30%) patients in the sMVS group developed a deficiency. The costs for the WLS forte® supplement were €38 versus €23 for sMVS. Additional return visits and associated costs for medical staff were the largest costs, up to 43% in the sMVS group. Total costs for supplementation with sMVS were €243 versus €134 for WLS Forte®. CONCLUSION: Preventing deficiencies with WLS Forte® seem initially more expensive than sMVS. However, treatment with WLS Forte® resulted in less vitamin and mineral deficiencies, which eventually resulted in less overall costs.

Availability and affordability of priority life-saving medicines for under-five children in health facilities of Tigray region, northern Ethiopia.

BACKGROUND: In developing countries, child health outcomes are influenced by the non-availability of priority life-saving medicines at public sector health facilities and non-affordability of medicines at private medicine outlets. This study aimed to assess availability, price components and affordability of priority life-saving medicines for under-five children in Tigray region, Northern Ethiopia. METHODS: A cross-sectional study was conducted in Tigray region from December 2015 to July 2016 using a standard method developed by the World Health Organization and Health Action International (WHO/HAI). Data on the availability and price of 27 priority life-saving medicines were collected from 31 public and 10 private sectors. Availability and prices were expressed in percent and median price ratios (MPRs), respectively. Affordability was reported in terms of the daily wage of the lowest-paid unskilled government worker. RESULTS: The overall availability of priority life-saving drugs in this study was low (34.1%). The average availabilities of all surveyed medicines in public and private sectors were 41.9 and 31.5%, respectively. The overall availability of medicines for malaria was found to be poor with average values of 29.3% for artemisinin combination therapy tablet, 19.5% for artesunate injection and 0% for rectal artesunate. Whereas, the availability of oral rehydration salt (ORS) and zinc sulphate dispersible tablets for the treatment of diarrhea was moderately high (90% for ORS and 82% for zinc sulphate). Medicines for pneumonia showed an overall percent availability in the range of 0% (ampicillin 250 mg and 1 g powder for injection and oxygen medicinal gas) to 100% (amoxicillin 500 mg capsule). The MPRs of 12 lowest price generic medicines were 1.5 and 2.7 times higher than the international reference prices (IRPs) for the private and public sectors, respectively. About 30% of priority life-saving medicines in the public sector and 50% of them in the private sector demanded above a single daily wages to purchase the standard treatment of the prevalent diseases of children. CONCLUSIONS: The lower availability, high price and low affordability of lowest price generic priority life-saving medicines in public and private sectors reflect a failure to implement the health policy on priority life-saving medicines in the region.

Reducing demand for ineffective health remedies: overcoming the illusion of causality.

OBJECTIVE: We tested a novel intervention for reducing demand for ineffective health remedies. The intervention aimed to empower participants to overcome the illusion of causality, which otherwise drives erroneous perceptions regarding remedy efficacy. DESIGN: A laboratory experiment adopted a between-participants design with six conditions that varied the amount of information available to participants (N = 245). The control condition received a basic refutation of multivitamin efficacy, whereas the principal intervention condition received a full contingency table specifying the number of people reporting a benefit vs. no benefit from both the product and placebo, plus an alternate causal explanation for inefficacy over placebo. MAIN OUTCOME MEASURES: We measured participants' willingness to pay (WTP) for multivitamin products using two incentivized experimental auctions. General attitudes towards health supplements were assessed as a moderator of WTP. We tested generalisation using ratings of the importance of clinical-trial results for making future health purchases. RESULTS: Our principal intervention significantly reduced participants' WTP for multivitamins (by 23%) and increased their recognition of the importance of clinical-trial results. CONCLUSION: We found evidence that communicating a simplified full-contingency table and an alternate causal explanation may help reduce demand for ineffective health remedies by countering the illusion of causality.

Vitamin D: too much testing and treating?

There is clinical uncertainty as to the testing of serum 25--Hydroxy vitamin D (25[OH]D) concentrations and when to use high-dose supplementation. Data show that there has been a rapid increase in the number of tests performed within the Northumbria Healthcare NHS Foundation Trust over the past 8 years and an increase in high-dose supplementation over the past 5 years. We performed a retrospective analysis of the 25(OH)D test requests over the period from January to -October 2017. A total of 17,405 tests were performed in this time period. The overall average concentration was 57.5 nmol/L and this figure was similar across age groups, although a larger proportion of patients aged over 75 had a concentration <25 nmol/L. Test requests were classified into 'appropriate', 'inappropriate' and 'uncertain' categories based on current expert opinion. We found that between 70.4% and 77.5% of tests could be inappropriate, depending on whether the 'uncertain' categories of falls and osteoporosis are considered to be justified. Tiredness, fatigue or exhaustion was the reason for testing in 22.4% of requests. We suggest that a more rational approach to testing, and subsequent treating, could lead to reductions in costs to the healthcare system and patients.

Vitamins for Cardiovascular Diseases: Is the Expense Justified?

Despite the knowledge that a well-balanced diet provides most of the nutritional requirements, the use of supplemental vitamins is widespread among adults in the United States. Evidence from large randomized controlled trials over the last 2 decades does not support vitamin supplementation for the reduction of cardiovascular risk factors or clinical outcomes. Many of the vitamins used in common practice likely are safe when consumed in small doses, but long-term consumption of megadoses is not only expensive but has the potential to cause adverse effects. Therefore, a need exists to revisit this issue, reminding the public and healthcare providers about the data supporting the use of vitamins for cardiovascular disease, and the potential for harm and the expense associated with their unnecessary use. In this review, we highlight the scientific evidence from randomized controlled studies regarding the efficacy and safety of vitamin supplementation for primary and secondary prevention of cardiovascular diseases and outcomes. We also draw attention to issues related to widespread and indiscriminate use of vitamin supplements and the need to educate the public to curtail unnecessary consumption and expense by limiting their use based on strong scientific evidence.

Costs of vitamin D testing and prescribing among children in primary care.

Vitamin D has attracted considerable interest in recent years, with a marked increase in diagnosis of vitamin D deficiency seen among children in clinical practice in the UK. The economic implications of this change in diagnostic behaviour have not been explored. We performed a cohort study to examine longitudinal trends in healthcare expenditure arising from vitamin D testing and prescribing for children in primary care in England, using the electronic healthcare records of 722,525 children aged 0-17 years held in The Health Improvement Network database. Combined costs of vitamin D tests and prescriptions increased from £1647 per 100,000 person-years in 2008 (95% CI, £934 to £3007) to £28,913 per 100,000 person-years in 2014 (95% CI, £26,361 to £31,739). The total cost of vitamin D prescriptions and tests for children in primary care at the national level in England in 2014 was estimated to be £4.31 million (95% CI, £2.96-£6.48 million). CONCLUSION: There has been a marked increase in healthcare expenditure on vitamin D tests and prescriptions for children in primary care over the past decade. Future research should explore the drivers for this change in diagnostic behaviour and the reasons prompting investigation of vitamin D status in clinical practice. What is Known: • Vitamin D deficiency has attracted considerable interest in recent years, with a marked increase in diagnosis seen in children. • The economic implications of this change in diagnostic behaviour have not been explored. What is New: • There has been a large increase in healthcare expenditure on vitamin D tests and prescriptions for children in primary care in England over the past decade (> 15 fold between 2008 and 2013). • Screening of vitamin D status in children without specific risk factors or clinical features of deficiency may represent avoidable healthcare expenditure.

Economic evaluation of vitamin D and calcium food fortification for fracture prevention in Germany.

OBJECTIVE: The study evaluates the economic benefit of population-wide vitamin D and Ca food fortification in Germany. DESIGN: Based on a spreadsheet model, we compared the cost of a population-wide vitamin D and Ca food-fortification programme with the potential cost savings from prevented fractures in the German female population aged 65 years and older. SETTING: The annual burden of disease and the intervention cost were assessed for two scenarios: (i) no food fortification; and (ii) voluntary food fortification with 20 µg (800 IU) of cholecalciferol (vitamin D3) and 200 mg of Ca. The analysis considered six types of fractures: hip, clinical vertebral, humerus, wrist, other femur and pelvis. SUBJECTS: Subgroups of the German population defined by age and sex. RESULTS: The implementation of a vitamin D and Ca food-fortification programme in Germany would lead to annual net cost savings of €315 million and prevention of 36 705 fractures in the target population. CONCLUSIONS: Vitamin D and Ca food fortification is an economically beneficial preventive health strategy that has the potential to reduce the future health burden of osteoporotic fractures in Germany. The implementation of a vitamin D and Ca food-fortification programme should be a high priority for German health policy makers because it offers substantial cost-saving potential for the German health and social care systems.

Longitudinal trends in use of dietary supplements by U.S. Army personnel differ from those of civilians.

Prevalence and patterns of dietary supplement (DS) use by U.S. Army soldiers differ from the civilian population. Longitudinal trends in use of DSs by civilians have been examined, but are unavailable in subpopulations such as military service members. The present study examined longitudinal changes in DS use by soldiers. A standardized questionnaire on DS use was administered in 2006-2007 (N = 989) and 2010-2011 (N = 1196) to convenience samples of active duty soldiers. Data were weighted for total population demographics of age, sex, and rank. Regular use of DSs by soldiers increased significantly (56% ± 1.6% vs. 64% ± 1.7%; p ≤ 0.001) over the 4 years primarily because of an increase of DS use among the youngest 18- to 24-year-old soldiers (43.0% ± 2.5% vs 62.3% ± 2.4%; p ≤ 0.01). Protein (22% ± 1.4% vs. 26% ± 1.5%; p ≤ 0.001) and combination (10.0% ± 1.0% vs. 24% ± 1.4%; p ≤ 0.001) product consumption also increased over the 4 years. Individual vitamin and mineral use - including iron, magnesium, selenium, and vitamins A, B6, B12, and D - significantly increased as well (p ≤ 0.05). In addition, expenditures on DSs by soldiers increased over time (p < 0.01). Reasons reported by soldiers for DS use suggest use increased to meet the occupational demands of military service. Educational interventions to minimize inappropriate use of DSs by soldiers are necessary to reduce adverse events resulting from unnecessary use of DSs and the financial burden associated with their use.

Consumption and reasons for use of dietary supplements in an Australian university population.

OBJECTIVE: The aim of this study was to examine the association between dietary supplement use and sociodemographic factors in an Australian university population. Additionally, reasons for use of specific dietary supplements were explored. METHODS: A cross-sectional online questionnaire was completed by 1633 students and staff members of Griffith University, Queensland, Australia (76% female). The questionnaire collected information on sociodemographic characteristics, use of dietary supplements, and reasons for use of each dietary supplement reported. Multiple regression analyses were used to describe the relationship between demographic factors and dietary supplement use. Pearson χ(2) was used to identify correlations between frequency of dietary supplement use and selected demographic factors. Frequency distributions were used to explore the reasons for use of each dietary supplement reported. RESULTS: Vitamin or mineral use and use of "other" dietary supplements was reported by 69% and 63% of participants, respectively. Age, sex, ethnicity, and physical activity were independently associated with dietary supplement use. Age, sex, and income were associated with acute use of specific dietary supplements during illness or injury. The reasons for use of specific dietary supplements were closely aligned with marketed claims. Broad reasons of health were commonly reported for use of most dietary supplements. CONCLUSIONS: Use of dietary supplements in this population reflects that of other countries. Individuals were unsure of the benefits and risks associated with dietary supplementation. Health professionals should account for dietary supplements when assessing diet. These results also warrant consideration by regulating bodies and public health officers to ensure safe practices.

Pellagra Pre-Goldberger: Rupert Blue, Fleming Sandwith, and The "Vitamine Hypothesis".

The conquest of pellagra is commonly associated with one name: Joseph Goldberger of the US Public Health Service, who in 1914 went south, concluded within 4 months that the cause was inadequate diet, spent the rest of his life researching the disease, and--before his death from cancer in 1929--found that brewer's yeast could prevent and treat it at nominal cost. It does Goldberger no discredit to emphasize that between 1907 and 1914 a patchwork coalition of asylum superintendents, practicing physicians, local health officials, and others established for the first time an English-language competence in pellagra, sifted through competing hypotheses, and narrowed the choices down to two: an insect-borne infection hypothesis, championed by the flamboyant European Louis Westerna Sambon, and the new "vitamine hypothesis," proffered by Casimir Funk in early 1912 and articulated later that year by two members of the American Clinical and Climatological Association, Fleming Mant Sandwith and Rupert Blue. Those who resisted Goldberger's inconvenient truth that the root cause was southern poverty drew their arguments largely from the Thompson-McFadden Pellagra Commission, which traces back to Sambon's unfortunate influence on American researchers. Thousands died as a result.

Cost-effectiveness of anti-oxidant vitamins plus zinc treatment to prevent the progression of intermediate age-related macular degeneration. A Singapore perspective.

PURPOSE: To determine if providing high dose anti-oxidant vitamins and zinc treatment age-related eye disease study (AREDS formulation) to patients with intermediate age-related macular degeneration (AMD) aged 40-79 years from Singapore is cost-effective in preventing progression to wet AMD. METHODS: A hypothetical cohort of category 3 and 4 AMD patients from Singapore was followed for 5 calendar years to determine the number of patients who would progress to wet AMD given the following treatment scenarios: (a) AREDS formulation or placebo followed by ranibizumab (as needed) for wet AMD. (b) AREDS formulation or placebo followed by bevacizumab (monthly) for wet AMD. (c) AREDS formulation or placebo followed by aflibercept (VIEW I and II trial treatment regimen). Costs were estimated for the above scenarios from the providers' perspective, and cost-effectiveness was measured by cost per disability-adjusted life year (DALY) averted with a disability weight of 0.22 for wet AMD. The costs were discounted at an annual rate of 3%. RESULTS: Over 5400 patients could be prevented from progressing to wet AMD cumulatively if AREDS formulation were prescribed. AREDS formulation followed by ranibizumab was cost-effective compared to placebo-ranibizumab or placebo-aflibercept combinations (cost per DALY averted: SGD$23,662.3 and SGD$21,138.8, respectively). However, bevacizumab (monthly injections) alone was more cost-effective compared to AREDS formulation followed by bevacizumab. CONCLUSION: Prophylactic treatment with AREDS formulation for intermediate AMD patients followed by ranibizumab or for patients who progressed to wet AMD was found to be cost-effective. These findings have implications for intermediate AMD screening, treatment and healthcare planning in Singapore.

Healthy Start vitamins--a missed opportunity: findings of a multimethod study.

OBJECTIVE: To evaluate and provide a real-life view of the operation of the Healthy Start vitamins scheme. SETTING: The study took place in primary care and community settings that served rural, urban and ethnically diverse populations, in two sentinel sites: London, and Yorkshire and the Humber. An online consultation and stakeholder workshops elicited views from across England. PARTICIPANTS: 669 health and social care practitioners including health visitors, midwives, public health practitioners, general practitioners, paediatricians and support staff participated in focus group discussions (n=49) and an online consultation (n=620). 56 participants representing health and social care practitioners, policymakers, service commissioners, and voluntary and independent sectors took part in stakeholder workshops. METHODS: Three-phase multimethod study comprising focus group discussions, an online consultation and stakeholder workshops. Qualitative data were analysed thematically and quantitative data from the online survey were analysed using descriptive statistics. RESULTS: Study participants were concerned about the low uptake of Healthy Start vitamin supplements and the consequences of this for health outcomes for women and young children. They experienced Healthy Start vitamin distribution as logistically complex, requiring the time, resources and creative thinking of a range of local and regional practitioners from senior strategists to administrative support workers. In the light of this, many participants argued that moving to universal provision of vitamin supplements would be more cost-effective than the current system. CONCLUSIONS: There is consistency of views of health practitioners that the current targeted system of providing free vitamin supplements for low-income childbearing women and young children via the Healthy Start programme is not fulfilling its potential to address vitamin deficiencies. There is wide professional and voluntary sector support for moving from the current targeted system to provision of free vitamin supplements for all pregnant and new mothers, and children up to their fifth birthday.