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      Assessing Health Consequences of Vitamin D Fortification Utilizing a Societal Experiment Design: Methodological Lessons Learned from the D-Tect Project

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          Abstract

          By utilizing historical changes in Danish legislation related to mandatory vitamin D fortification of margarine, which was implemented in the mid 1930s and abruptly abandoned in June 1985, the studies in the D-tect project investigated the effects of vitamin D on health outcomes in individuals, who during gestation were exposed or unexposed to extra vitamin D from fortified margarine. This paper reviews and narratively summarizes the analytic approaches alongside the results of the societal fortification experiment studies from the D-tect project and addresses the challenges in designing societal experiment studies and evaluating their results. The latter are discussed as lessons learned that may be useful for designers of similar studies, expected to be extensively utilized while researching the health consequences of the COVID-19 pandemic by comparing individuals born before and after the epidemic. In the D-tect project, 16 articles based on the societal fortification experiment were published analyzing 10 different outcomes and using different statistical approaches. Lessons learned included the detail of the analysis of the historical information on the exposure, availability and validity of the outcome data, variety of analytical approaches, and specifics concerning vitamin D effect evaluation, such as consideration of the influence of sunshine or season. In conclusion, the D-tect project clearly demonstrated the cost-effectiveness and research potential of natural- or societal-experiment-based studies.

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          Most cited references39

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          The Danish Civil Registration System.

          The Danish Civil Registration System (CRS) was established in 1968, and all persons alive and living in Denmark were registered for administrative use. CRS includes individual information on the unique personal identification number, name, gender, date of birth, place of birth, citizenship, identity of parents and continuously updated information on vital status, place of residence and spouses. Since 1968, CRS has recorded current and historical information on all persons living in Denmark. Among persons born in Denmark in 1960 or later it contains complete information on maternal identity. For women born in Denmark in April 1935 or later it contains complete information on all their children. CRS contains complete information on immigrations and emigrations from 1969 onwards, permanent residence in a Danish municipality from 1971 onwards, and full address in Denmark from 1977 onwards. CRS in connection with other registers and biobanks will continue to provide the basis for significant knowledge relevant to the aetiological understanding and possible prevention of human diseases.
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            The Danish National Patient Register.

            The Danish National Patient Register (NPR) was established in 1977, and it is considered to be the finest of its kind internationally. At the onset the register included information on inpatient in somatic wards. The content of the register has gradually been expanded, and since 2007 the register has included information on all patients in Danish hospitals. Although the NPR is overall a sound data source, both the content and the definitions of single variables have changed over time. Changes in the organisation and provision of health services may affect both the type and the completeness of registrations. The NPR is a unique data source. Researchers using the data should carefully consider potential fallacies in the data before drawing conclusions.
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              The fetal and infant origins of adult disease.

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                Author and article information

                Contributors
                Role: Academic Editor
                Journal
                Int J Environ Res Public Health
                Int J Environ Res Public Health
                ijerph
                International Journal of Environmental Research and Public Health
                MDPI
                1661-7827
                1660-4601
                31 July 2021
                August 2021
                : 18
                : 15
                : 8136
                Affiliations
                [1 ]Research Unit for Dietary Studies, The Parker Institute, Bispebjerg and Frederiksberg Hospital, 2000 Frederiksberg, Denmark; fanney.thorsteinsdottir@ 123456regionh.dk (F.T.); moos.caroline@ 123456gmail.com (C.M.); katrinesideniusduus@ 123456gmail.com (K.S.D.); berit.lilienthal.heitmann@ 123456regionh.dk (B.L.H.)
                [2 ]Department of Pharmacy, University of Copenhagen, 2100 Copenhagen, Denmark; ramune.jacobsen@ 123456sund.ku.dk
                [3 ]Department of Public Health, University of Copenhagen, 1014 Copenhagen, Denmark; amelie.keller@ 123456sund.ku.dk
                [4 ]Center for Early Intervention and Family Studies, Department of Psychology, University of Copenhagen, 1353 Copenhagen, Denmark; maria.stougaard@ 123456psy.ku.dk
                [5 ]Center for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, 2000 Frederiksberg, Denmark; camilla.bjoern.jensen@ 123456regionh.dk
                [6 ]Lifestyle, Reproduction and Cancer, Danish Cancer Society Research Center, 2100 Copenhagen, Denmark; allan@ 123456cancer.dk
                [7 ]Department of Obstetrics and Gynaecology, Aalborg University Hospital and Aalborg University, 9000 Aalborg, Denmark; u.kesmodel@ 123456rn.dk
                [8 ]Open Patient Explorative Network, Department of Clinical Research, University of Southern Denmark, 5000 Odense, Denmark; b.abrahamsen@ 123456physician.dk
                [9 ]Department of Medicine, Holbæk Hospital, 4300 Holbæk, Denmark
                [10 ]Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford OX3 7FY, UK
                [11 ]The Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders, University of Sydney, Sydney, NSW 2006, Australia
                Author notes
                [†]

                These authors contributed equally to this article.

                Author information
                https://orcid.org/0000-0001-8256-8756
                https://orcid.org/0000-0002-8142-9807
                https://orcid.org/0000-0002-3070-782X
                https://orcid.org/0000-0003-4997-4319
                https://orcid.org/0000-0002-1630-3132
                https://orcid.org/0000-0002-6809-4504
                Article
                ijerph-18-08136
                10.3390/ijerph18158136
                8345774
                34360427
                290838a9-5091-4707-9e25-1311c2b7785f
                © 2021 by the authors.

                Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ( https://creativecommons.org/licenses/by/4.0/).

                History
                : 16 June 2021
                : 23 July 2021
                Categories
                Review

                Public health
                vitamin d,pregnancy,chronic diseases,semi-ecological study
                Public health
                vitamin d, pregnancy, chronic diseases, semi-ecological study

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