Belgian Consensus Recommendations to Prevent Vitamin K Deficiency Bleeding in the Term and Preterm Infant.

Neonatal vitamin K prophylaxis is essential to prevent vitamin K deficiency bleeding (VKDB) with a clear benefit compared to placebo. Various routes (intramuscular (IM), oral, intravenous (IV)) and dosing regimens were explored. A literature review was conducted to compare vitamin K regimens on VKDB incidence. Simultaneously, information on practices was collected from Belgian pediatric and neonatal departments. Based on the review and these practices, a consensus was developed and voted on by all co-authors and heads of pediatric departments. Today, practices vary. In line with literature, the advised prophylactic regimen is 1 or 2 mg IM vitamin K once at birth. In the case of parental refusal, healthcare providers should inform parents of the slightly inferior alternative (2 mg oral vitamin K at birth, followed by 1 or 2 mg oral weekly for 3 months when breastfed). We recommend 1 mg IM in preterm <32 weeks, and the same alternative in the case of parental refusal. When IM is perceived impossible in preterm <32 weeks, 0.5 mg IV once is recommended, with a single additional IM 1 mg dose when IV lipids are discontinued. This recommendation is a step towards harmonizing vitamin K prophylaxis in all newborns.

A comprehensive approach for the simultaneous analysis of all main water-soluble vitamins in multivitamin preparations by a stability-indicating HPLC-DAD method.

A stability-indicating HPLC-DAD method for simultaneous determination of all nine main water-soluble vitamins, in addition to two commonly used vitamers, was developed and fully validated in analytical ranges, adjusted to their recommended dietary allowance values. An XSelect CSH C18 column with gradient elution using phosphate buffer and methanol was used for their optimal separation. The results from forced degradation studies along with peak purity tests and response ratios at dual wavelengths for the individual vitamins in all tested samples confirmed the method's stability-indicative nature. The complete developed methodology, including a single sample preparation for the vitamins simultaneous analysis, was applied to their assay in 13 commercial multivitamin preparations, revealing mostly higher amounts than the label claims. The developed method is applicable for stability testing, multivitamin products shelf-life determination as well as routine assay analysis of all water-soluble vitamins in their most common forms, including the analytically most demanding flavin mononucleotide.

Dietary intake of amino acids and vitamins compared to NRC requirements in obese cats undergoing energy restriction for weight loss.

BACKGROUND: This study aimed to determine if obese cats undergoing energy restriction for weight loss would meet the National Research Council's (NRC) indispensable amino acid and vitamin recommendations when fed a purpose-formulated diet. Thirty cats were placed into one of two groups; obese (BCS 8 to 9/9; n = 16) and lean (BCS 4 to 5/9; n = 14) and included in a non-randomized retrospective observational study. Cats were fed a veterinary weight loss food during a 4-week period of weight maintenance. Obese cats (O-MAINT) refers to obese cats during this period, L-MAINT to lean cats. After this initial 4-week period, the lean cats finished the study at this time and the 16 obese cats continued and were energy restricted for a 10-week period (O-RESTRICT). Analysis for dietary concentrations of indispensable amino acid and vitamin contents were performed. Daily food intakes were used to determine minimum, maximum and average daily intakes of individual nutrients for all three groups and compared against NRC 2006 minimum requirements (MR), adequate intakes (AI) and recommended allowances (RA) for adult cats. RESULTS: Over 10 weeks, O-RESTRICT cats lost 672 g ± 303 g, representing a weight loss rate of 0.94 ± 0.28% per week. Daily intake of the majority of indispensable amino acids and vitamins was greater than the NRC 2006 recommended allowance (RA per kg ideal body weight ^0.67), except for arginine, choline, crude protein, phenylalanine plus tyrosine and threonine. All O-RESTRICT cats had minimum, average, and maximum arginine intakes less than the NRC AI. Minimum daily intake of choline was below NRC RA for all O-RESTRICT cats and below NRC MR for two. All, except one, O-RESTRICT cats had a maximum and average choline intake below RA. CONCLUSIONS: All cats remained clinically healthy and showed no clinical signs of deficiency. Dietary choline and arginine requirements of obese cats as well as health risks associated with low dietary intake during energy restriction warrant further investigation.

Niveles máximos de vitaminas y minerales en complementos alimenticios en Europa / Maximum levels of vitamins and minerals in food supplements in Europe

La legislación de la UE estableció qué factores deben aplicarse para la fijación de niveles máximos de vitaminas y minerales en los complementos alimenticios y en otros alimentos enriquecidos con estos nutrientes, considerando la distinta sensibilidad de los grupos poblacionales, a fin de minimizar los riesgos de una ingesta excesiva. Una década y media después, todavía no se han fijado dichos niveles máximos. A causa de esta demora, en muchos países europeos se han establecido para los complementos alimenticios cantidades máximas diarias, con grandes diferencias de un país a otro. En Francia se acaban de actualizar estos niveles máximos tomando en consideración la edad, la situación fisiológica y el estado de salud de los grupos de población: niños de 1-3 años, niños de 3-10 años, adolescentes de 11-17 años, adultos, mujeres con probabilidad de embarazo, embarazadas, mujeres lactantes, menopausia, ancianos, fumadores, pacientes que reciben un tratamiento anticoagulante, pacientes renales, etc

EU legislation established the factors that should be applied for the setting of maximum levels of vitamins and minerals in food supplements and other foods enriched with these nutrients, considering the different sensitivity of the population groups, in order to minimize the risks of an excessive intake. A decade and a half later, these maximum levels have not yet been set. Because of this delay, in many European countries maximum daily amounts have been established for food supplements, with great differences from one country to another. In France, these maximum levels have just been updated taking into account the age, the physiological situation and the state of health of the population groups: children of 1-3 years, children of 3-10 years, adolescents of 11-17 years, adults, women with probability of pregnancy, pregnant women, lactating women, menopause, old people, smokers, patients receiving anticoagulant treatment, renal patients, etc

Evolution of reference materials for the determination of organic nutrients in food and dietary supplements-a critical review.

For over 40 years, food-matrix certified reference materials (CRMs) have been available for determination of trace element content, and a wide variety of materials are available from most producers of CRMs. However, the availability of food-matrix CRMs for organic nutrients has been more limited. The European Commission (EC) Bureau Communautaire de Référence (BCR) and the National Institute of Standards and Technology (NIST) introduced food-matrix CRMs with values assigned for vitamins and other organic nutrients such as fatty acids and carotenoids in the 1990s. The number of organic nutrients for which values were assigned has increased significantly in the past decade, and the approach and analytical methods used for assignment of the certified values have also evolved. Recently, dietary supplement-matrix CRMs such as multivitamin tablets with values assigned for vitamins and carotenoids, and fish and plant oils with values assigned for fatty acids have appeared. The development, evolution, and improvement of food- and dietary supplement-matrix CRMs for determination of vitamins, carotenoids, and fatty acids are described, with emphasis on CRMs made available in the past 10 years. Recent food and dietary supplement CRMs for the determination of organic nutrients include infant formula, multivitamin tablets, milk and egg powders, breakfast cereal, meat homogenate, blueberries, soy flour, fish and plant oils, dry cat food, and protein drink powder. Many of these food- and supplement-matrix CRMs have values assigned for over 80 organic and inorganic nutrients, toxic elements, proximates, and contaminants. The review provides a critical assessment of the challenges and evolving improvements in the production and the analytical methods used for value assignment of these CRMs. The current status and future needs for additional food- and dietary supplement-matrix CRMs for organic nutrients are also discussed. Graphical abstract Food Composition Triangle with currently-available food-matrix certified reference materials (CRMs) for the determination of organic nutrients positioned according to fat, protein, and carbohydrate composition.

Increasing Vitamin D Serum Levels Is Associated With Reduced Pulmonary Exacerbations in Patients With Cystic Fibrosis.

CONTEXT: In 2012, The North American Cystic Fibrosis Foundation (NACFF) published new guidelines for the treatment of vitamin D deficiency in individuals with cystic fibrosis (CF). OBJECTIVE: The objectives of our study were to assess the efficacy of these guidelines, and to test the effect of increasing vitamin D dosage on pulmonary function and exacerbations. DESIGN: Pulmonary function tests and serum concentrations of 25-hydroxyvitamin D [25(OH)D] were measured 1 year before increasing vitamin D dosage according to the guidelines and at least 1 year later. In addition, days of hospitalization and pulmonary exacerbations were counted and an average per year (average number of days of hospitalization and average number of pulmonary exacerbations [PEA], respectively) was calculated. SETTING AND PARTICIPANTS: A total of 90 patients from The Cystic Fibrosis Clinic at Hadassah Mount-Scopus Hospital, Jerusalem, Israel. RESULTS: The mean serum concentration of vitamin D increased significantly from 20.97 ng/mL (52.34 nmol/L) at baseline to 25.41 ng/mL (63.42 nmol/L) at the end of follow-up (P < 0.001). The number of PEA decreased significantly from 2.79 ±â€Š3.96 to 2.15 ±â€Š2.91 (P = 0.007). The change in vitamin D levels was correlated with a decrease in PEA (correlation coefficient = -0.318, P = 0.002). CONCLUSIONS: The NACFF guidelines for management of vitamin D deficiency improve vitamin D levels in patients with CF but did not reach the normal values in most patients. The increase in vitamin D serum levels was, however, associated with a decrease in number of pulmonary exacerbations.

[Food Supplements - Considerations in Medical Practice]. / Nahrungsergänzungsmittel: Bedeutung in der ärztlichen Praxis.

Food supplements in Europe are subject to food safety legislation. They should not be confused with pharmaceuticals. Rather, they are foods, whose purpose is to supplement the normal diet, and represent concentrated sources of nutrients (i. e. vitamins and minerals, including trace elements) or other substances with a nutritional or physiological effect. Nevertheless, it should be kept in mind that consumers may in some cases use food supplements for the purpose of self-medication. In the context of anamnesis, physicians should specifically question their patients about the use of food supplements. This can be of significant relevance for evaluation of possible undesirable or adverse effects, influences on laboratory parameters, or interactions with pharmaceuticals, which may be due to consumption of certain products that are marketed as food supplements. Furthermore, education of patients with respect to the possible benefits and risks related to the use of vitamins, minerals and other constituents of food supplements should be intensified.

Nutritionally recommended food for semi- to strict vegetarian diets based on large-scale nutrient composition data.

Diet design for vegetarian health is challenging due to the limited food repertoire of vegetarians. This challenge can be partially overcome by quantitative, data-driven approaches that utilise massive nutritional information collected for many different foods. Based on large-scale data of foods' nutrient compositions, the recent concept of nutritional fitness helps quantify a nutrient balance within each food with regard to satisfying daily nutritional requirements. Nutritional fitness offers prioritisation of recommended foods using the foods' occurrence in nutritionally adequate food combinations. Here, we systematically identify nutritionally recommendable foods for semi- to strict vegetarian diets through the computation of nutritional fitness. Along with commonly recommendable foods across different diets, our analysis reveals favourable foods specific to each diet, such as immature lima beans for a vegan diet as an amino acid and choline source, and mushrooms for ovo-lacto vegetarian and vegan diets as a vitamin D source. Furthermore, we find that selenium and other essential micronutrients can be subject to deficiency in plant-based diets, and suggest nutritionally-desirable dietary patterns. We extend our analysis to two hypothetical scenarios of highly personalised, plant-based methionine-restricted diets. Our nutrient-profiling approach may provide a useful guide for designing different types of personalised vegetarian diets.

Challenges in Developing Analytically Validated Laboratory-Derived Dietary Supplement Databases.

The Dietary Supplement Label Database (DSLD) is sponsored by the Office of Dietary Supplements (ODS) and the National Library of Medicine (NLM). It provides a searchable, free database of the contents of ∼65,000 supplement labels. A companion database of analytically verified product labels [the Dietary Supplement Ingredient Database (DSID)] was created by ODS, NLM, and the USDA. There are considerable challenges to populating both databases, but the DSID faces unique analytic chemistry challenges. This article describes the challenges to creating analytically verified marketplace surveys of dietary supplement (DS) product content claims for inclusion in public databases. Nutritionists and public health scientists require information on actual exposures to DS constituents because labeled content may not match labeled product content. Analytic verification of composition of DSs provides a link to actual exposure. A public database of analytically derived DS content was developed to provide more accurate estimates of dietary intake in population-based epidemiologic studies. The DSID has conducted surveys of several types of vitamin- and mineral-containing DSs. Results showing label content claims as analytically derived values are available in the current DSID. A recent pilot project explored the feasibility of adding botanical DS products to the DSID. Candidates for future botanical DSID studies will be based on sales volume, potential public health impacts, and the availability of validated analytic methods and reference materials. Databases like DSID and the DSLD are essential for researchers and clinicians to evaluate dietary ingredient intakes in population-based epidemiologic studies. Together, these databases provide a picture of the DS marketplace. The DSID provides an analytic survey of marketed DSs. However, selection of future botanical supplements for DSID evaluation involves analytic challenges. Even when appropriate resources are available, method selection and data evaluation are resource- and time-consuming.

Dietary Supplement Ingredient Database (DSID) and the Application of Analytically Based Estimates of Ingredient Amount to Intake Calculations.

OBJECTIVE: We describe the purpose of the Dietary Supplement Ingredient Database (DSID), the statistical methodology underlying online calculators of analytically verified supplement content estimates, and the application and significance of DSID label adjustments in nutritional epidemiology. BACKGROUND AND HISTORY: During dietary supplement (DS) manufacturing, many ingredients are added at higher than declared label amounts, but overages are not standardized among manufacturers. As a result, researchers may underestimate nutrient intakes from DSs. The DSID provides statistical tools on the basis of the results of chemical analysis to convert label claims into analytically predicted ingredient amounts. These adjustments to labels are linked to DS products reported in NHANES. RATIONALE: Tables summarizing the numbers of NHANES DS products with ingredient overages and below label content show the importance of DSID adjustments to labels for accurate intake calculations. RECENT DEVELOPMENTS: We show the differences between analytically based estimates and labeled content for vitamin D, calcium, iodine, caffeine, and omega-3 (n-3) fatty acids and their potential impact on the accuracy of intake assessments in large surveys. Analytical overages >20% of label levels are predicted for several nutrients in 50-99% of multivitamin-mineral products (MVMs) reported in NHANES: for iodine and selenium in adult MVMs, for iodine and vitamins D and E in children's MVMs, and for iodine, chromium, and potassium in nonprescription prenatal MVMs. Predicted overages of 10-20% for calcium can be applied to most MVMs and overages >10% for folic acid in the vast majority of adult and children's MVMs. FUTURE DIRECTIONS: DSID studies are currently evaluating ingredient levels in prescription prenatal MVMs and levels of constituents in botanical DSs. CONCLUSIONS: We estimate that the majority of MVM products reported in NHANES have significant overages for several ingredients. It is important to account for nonlabeled additional nutrient exposure from DSs to better evaluate nutritional status in the United States.

Bone health and adherence to vitamin D and calcium therapy in early breast cancer patients on endocrine therapy with aromatase inhibitors.

OBJECTIVES: Randomized trials involving aromatase inhibitors (AIs) in the adjuvant treatment of breast cancer patients have reported increased osteoporosis risk. Bone loss can be reduced with appropriate life style, vitamin D and calcium supplements, and with bisphosphonate therapy. The aim of this analysis was to investigate adherence to vitamin D and calcium in postmenopausal breast cancer patients receiving adjuvant non-steroidal AIs, and oncologists' adherence to the bone health guidelines. MATERIAL AND METHODS: This prospective study included 438 newly diagnosed patients and those who have already been receiving non-steroidal AIs for up to 3.5 years. Median endocrine therapy duration before recruitment in the study was 10.5 months (interquartile 4.8-26.6). RESULTS: Densitometry was performed on 142 patients (32.4%) before initiation of endocrine therapy, and on additional 38 (8.6%) patients at second study visit. Densitometry was not performed on 258 (59%) patients. Vitamin D and calcium were prescribed to 329/438 (75.1%) patients at some point during the study. Patients who took more than 80% of the prescribed dose were considered adherent. Self-reported adherence was 88.4%. Osteoporosis was diagnosed in 24 patients (5.5%) of the total study population, bearing in mind that 258/438 (59%) patients did not have densitometry. Bisphosphonates were prescribed to 54/438 (12.3%) patients, whilst only 19 (35.2%) of those had osteoporosis. CONCLUSION: In this analysis, lack of oncologists' adherence to the bone health guidelines was observed. In addition, a significant proportion of the patients did not adhere to the vitamin D and calcium.

Dietary supplements: What's in a name? What's in the bottle?

The Dietary Supplement Health and Education Act of 1994 (DSHEA), which arbitrarily classified herbals and other medicinal products as dietary supplements, obscured fundamental differences between two classes of products. Authentic supplements to the diet, such as multivitamins or calcium, have nutritional value and are safe. Herbals are used worldwide as medicines, they do not supplement the diet, they may cause severe adverse events, and they should be regulated as medicines. DSHEA also prevented the Food and Drug Administration (FDA) from effectively regulating herbal supplements as medicines. One consequence of weak FDA regulatory oversight is the poor quality of herbals. FDA inspections of manufacturing facilities have revealed violations of good manufacturing practices in over half of facilities inspected, including unsanitary conditions and lack of product specifications. Moreover, many "all natural" herbals marketed for weight loss, enhancement of sexual health and improving sports performance are adulterated with prescription and over-the-counter medications that have caused adverse cardiovascular events. New procedures to authenticate the identity of plants used in herbals will neither detect adulteration by medications nor provide assurance of appropriate pharmacological activity or safety. Nonvitamin, nonmineral "supplements" should be regulated as medicines, but revision or repeal of DSHEA faces strong opposition in Congress. The marketing of botanical supplements is based on unfounded claims that they are safe and effective. Health professionals need to inform patients and the public that there is no reason to take herbal medicines whose composition and benefits are unknown, and whose risks are evident.

The history of efforts to regulate dietary supplements in the USA.

This review examines the emergence of dietary supplements and how the Food and Drug Administration (FDA) attempted to regulate these, beginning with the arrival of vitamins and how these were managed under the 1906 Food and Drugs Act, and ending with the seismic influence of the 1994 Dietary Supplement Health and Education Act (DSHEA). Included are the impact of major laws, key court decisions, and the construction of the FDA's supplement actions and rules from the 1920s to the 1990s for products that were neither drugs nor typical foods. Stiff resistance to the regulations by supplement manufacturers, trade associations, politicians, and especially the public at large is an important part of this story. The paper closes with the passage of DSHEA and how it literally changed the definition and parameters of control of dietary supplements. Copyright © 2015 John Wiley & Sons, Ltd.

A Call to Action to Bring Safer Parenteral Micronutrient Products to the U.S. Market.

The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) started an intensive review of commercially available parenteral vitamin and trace element (TE) products in 2009. The chief findings were that adult multi-TE products currently available in the United States (U.S.) provide potentially toxic amounts of manganese, copper, and chromium, and neonatal/pediatric multi-TE products provide potentially toxic amounts of manganese and chromium. The multivitamin products appeared safe and effective; however, a separate parenteral vitamin D product is needed for those patients on standard therapy who continue to be vitamin D depleted and are unresponsive to oral supplements. The review process also extended to parenteral choline and carnitine. Although choline and carnitine are not technically vitamins or trace elements, choline is an essential nutrient in all age groups, and carnitine is an essential nutrient in infants, according to the Food and Nutrition Board of the Institute of Medicine. A parenteral choline product needs to be developed and available. Efforts are currently under way to engage the U.S. Food and Drug Administration (FDA) and the parenteral nutrient industry so A.S.P.E.N.'s recommendations can become a commercial reality.

Multivitamins/multiminerals in Switzerland: not as good as it seems.

BACKGROUND: Multivitamin/multimineral (MVM) supplements are commonly consumed by the general population, but little is known regarding their composition and compliance with local regulations. We assessed the composition and compliance with regulations [no indication in the label of vitamin/minerals amounting <15% of the acceptable daily intake (ADI)] of MVM available in Switzerland. METHODS: The composition of vitamin/minerals supplements was obtained from the Swiss drug compendium, the Internet, pharmacies, parapharmacies and supermarkets. MVM was defined as the presence of at least 5 vitamins and/or minerals. RESULTS: Of the 254 vitamin/mineral supplements collected, 95 (37%) were considered as MVM. The most frequent vitamins were B6 (73.7%), C (71.6%), B2 (69.5%) and B1 (67.4%); the least frequent were K (17.9%), biotin (51.6%), pantothene (55.8%) and E (56.8%). Approximately half of MVMs provided >150% of the ADI for vitamins. The most frequent minerals were zinc (66.3%), calcium (55.8%), magnesium (54.7%) and copper (48.4%), and the least frequent were fluoride (3.2%), phosphorous (17.9%), chrome (22.1%) and iodine (25%). More than two thirds of MVMs provided between 50 and 150% of the ADI for minerals, and few MVMs provided >150% of the ADI. While few MVMs provided <15% of the ADI for vitamins, a considerable fraction did so for minerals (32.7% for magnesium, 26.1% for copper and 22.6% for calcium). CONCLUSION: There is a great variability regarding the composition of MVMs available in Switzerland. Several MVM do not comply with Swiss regulations, which calls for monitoring and corrective measures.