A code for clinical trials centralized monitoring, sharing open-science solutions to high-quality data.

Monitoring of clinical trials is critical to the protection of human subjects and the conduct of high-quality research. Even though the adoption of risk-based monitoring (RBM) has been suggested for many years, the RBM approach has been less widespread than expected. Centralized monitoring is one of the RMB pillars, together with remote-site monitoring visits, reduced Source Data Verification (SDV) and Source Document Reviews (SDR).

Factors that affect zinc bioavailability and losses in adult and elderly populations.

The most widely used method for estimating dietary zinc requirements is the factorial approach, in which it is assumed, in adults, that the physiological zinc requirement is the lowest intake that replaces endogenous zinc losses. Presented here are the results of two reviews: a narrative review of zinc losses from the human body and a systematic review of factors affecting zinc bioavailability in adult and elderly populations. The narrative review presents data on losses from integumental and excretory routes, obtained from 29 papers published up to April 2013.

EURRECA-Estimating zinc requirements for deriving dietary reference values.

Zinc was selected as a priority micronutrient for EURRECA, because there is significant heterogeneity in the Dietary Reference Values (DRVs) across Europe. In addition, the prevalence of inadequate zinc intakes was thought to be high among all population groups worldwide, and the public health concern is considerable. In accordance with the EURRECA consortium principles and protocols, a series of literature reviews were undertaken in order to develop best practice guidelines for assessing dietary zinc intake and zinc status.

EURRECA-Estimating iron requirements for deriving dietary reference values.

Currently, a factorial approach is used to derive reference values for iron. Calculations include the use of a bioavailability factor to convert the physiological requirement, derived from obligatory losses and requirements for growth and development, into a dietary intake value. A series of systematic reviews undertaken by the EURRECA Network of Excellence aimed to identify data that may increase the accuracy of factorial calculations across all population groups.

EURRECA-Evidence-based methodology for deriving micronutrient recommendations.

The EURopean micronutrient RECommendations Aligned (EURRECA) Network of Excellence explored the process of setting micronutrient recommendations to address the variance in recommendations across Europe. Work centered upon the transparent assessment of nutritional requirements via a series of systematic literature reviews and meta-analyses. In addition, the necessity of assessing nutritional requirements and the policy context of setting micronutrient recommendations was investigated.

Consumer involvement in dietary guideline development: opinions from European stakeholders.

Objective: The involvement of consumers in the development of dietary guidelines has been promoted by national and international bodies. Yet, few best practice guidelines have been established to assist with such involvement.

Design: Qualitative semi-structured interviews explored stakeholders' beliefs about consumer involvement in dietary guideline development.

Association between vitamin B12 intake and EURRECA's prioritized biomarkers of vitamin B12 in young populations: a systematic review.

Objective: To review evidence on the associations between vitamin B12 intake and its biomarkers, vitamin B12 intake and its functional health outcomes, and vitamin B12 biomarkers and functional health outcomes.

Design: A systematic review was conducted by searching electronic databases, until January 2012, using a standardized strategy developed in the EURRECA network. Relevant articles were screened and sorted based on title and abstract, then based on full text, and finally included if they met inclusion criteria.

Effect of folate supplementation on folate status and health outcomes in infants, children and adolescents: a systematic review.

The aim of this systematic review was to collect all available randomized controlled trials on the effect of folate supplementation on folate status and health outcomes within the paediatric age group. The method included a structured search strategy on MEDLINE, Embase and Cochrane databases, with formal inclusion/exclusion criteria and data extraction procedure. We included 26 studies.

The effect of iron on cognitive development and function in infants, children and adolescents: a systematic review.

A systematic review was conducted to summarize the evidence currently available from randomized controlled trials (RCTs) concerning the effect of iron intake of infants, children and adolescents on measures of cognitive development and function. The Cochrane Library, MEDLINE and Embase were searched up to and including February 2010. Studies were also identified by checking the bibliographies of the articles retrieved.

Critical micronutrients in pregnancy, lactation, and infancy: considerations on vitamin D, folic acid, and iron, and priorities for future research.

The Early Nutrition Academy and the European Commission-funded EURRECA Network of Excellence jointly sponsored a scientific workshop on critical micronutrients in pregnancy, lactation, and infancy. Current knowledge and unresolved questions on the supply of vitamin D, folic acid, and iron for pregnant women, lactating women, and infants, and their health effects were discussed. The question was addressed of whether, and under which circumstances, supplementation with these micronutrients in addition to usual dietary intakes is advisable.

Is the food frequency questionnaire suitable to assess micronutrient intake adequacy for infants, children and adolescents?

The objective of this study was to review how accurately micronutrient intakes in infants, children, and adolescents were assessed with validated food frequency questionnaires (FFQs) to which study quality criteria had been applied. The methodology and the analysis presented were based on several research activities carried out within the European Micronutrient Recommendation Aligned Network of Excellence. The analysis was limited to vitamin D, vitamin C, vitamin B₁₂, folate, selenium, iron, zinc, iodine, calcium, and copper.

Methodological aspects of the study of dietary patterns during pregnancy and maternal and infant health outcomes. A systematic review.

The objective of the present study was to systematically review the literature exploring the associations between different dietary patterns obtained from Food Frequency Questionnaires during pregnancy and the development of health-related maternal and infant outcomes in the Framework of the EURRECA Network of Excellence. A systematic search was conducted on Pubmed for literature published up to September 2009. The search strategy resulted in an initial amount of 2048 articles.

Physiological and public health basis for assessing micronutrient requirements in children and adolescents. The EURRECA network.

This paper provides an overview of the current knowledge relating to the nutritional requirements and corresponding recommended nutrient intake values of children and adolescents for micronutrients and specificities related to these requirements in the course of childhood and adolescence in Europe. Aspects that can influence micronutrient requirements, such as physiological requirements and bioavailability of the nutrients in the organism, are discussed. The methodology used to obtain the data and also the main knowledge gaps regarding these concepts are emphasized.

The nutritional requirements of infants. Towards EU alignment of reference values: the EURRECA network.

This paper presents a review of the current knowledge regarding the macro- and micronutrient requirements of infants and discusses issues related to these requirements during the first year of life. The paper also reviews the current reference values used in European countries and the methodological approaches used to derive them by a sample of seven European and international authoritative committees from which background scientific reports are available. Throughout the paper, the main issues contributing to disparities in micronutrient reference values for infants are highlighted.

Nutritional requirements during lactation. Towards European alignment of reference values: the EURRECA network.

There is considerable variation in reference values for micronutrient intake during lactation across Europe. The European Micronutrients Recommendations Aligned project aims to harmonize dietary recommendations throughout Europe. Recommended nutrient intakes during lactation are based on limited data and are often extrapolated from known secretion of the nutrient in milk with adjustments for bioavailability, so that differences between values can be partly ascribed to differences in methodological approaches and how these approaches were applied.

Perinatal folate supply: relevance in health outcome parameters.

The importance of physiological supply of folate is well recognized in human health; the crucial roles of folate in one-carbon metabolism for physiological DNA synthesis and cell division, as well as in the conversion of homocysteine (Hcy) to methionine, and subsequently, to S-adenosylmethionine, have been convincingly demonstrated. Improved folate status may reduce the risk of macrocytic anaemia, cardiovascular diseases, neuropsychiatric disorders and adverse pregnancy outcomes. Inadequate folate status results in a decrease in the methylation cycle and in increased blood levels of the neurotoxic Hcy.

Critical issues in setting micronutrient recommendations for pregnant women: an insight.

The European Micronutrient Recommendations Aligned (EURRECA) Network aims to provide standardized approaches to reveal and beneficially influence variability within the European Union in micronutrient recommendations for vulnerable population groups. Characterization of the 'vulnerability' together with the 'variability' of micronutrient needs represents the first step to creating guidelines for setting micronutrient recommendations within target populations. This paper describes some of the key factors and characteristics relevant to assess micronutrient requirements and formulate recommendations of micronutrients in pregnancy.

The process of setting micronutrient recommendations: a cross-European comparison of nutrition-related scientific advisory bodies.

Objective: To examine the workings of the nutrition-related scientific advisory bodies in Europe, paying particular attention to the internal and external contexts within which they operate.

Design: Desk research based on two data collection strategies: a questionnaire completed by key informants in the field of micronutrient recommendations and a case study that focused on mandatory folic acid (FA) fortification.

Setting: Questionnaire-based data were collected across thirty-five European countries.