Vitamin D supplementation compared to placebo in people with First Episode psychosis - Neuroprotection Design (DFEND): a protocol for a randomised, double-blind, placebo-controlled, parallel-group trial Gaughran, Fiona, Stringer, Dominic, Berk, Michael, Smith, Shubulade, Taylor, David, Whiskey, Eromona, Landau, Sabine, Murray, Robin, McGuire, Philip, Gardner-Sood, Poonam, Wojewodka, Gabriella, Ciufolini, Simone, Jordan, Harriet, Clarke, Jessie, Allen, Lauren, Krivoy, Amir, Stubbs, Brendon, Lowe, Philippa, Arbuthnott, Maurice, Rathod, Shanaya, Boardman, Andrew, Firdosi, Mudasir and McGrath, John J. 2020, Vitamin D supplementation compared to placebo in people with First Episode psychosis - Neuroprotection Design (DFEND): a protocol for a randomised, double-blind, placebo-controlled, parallel-group trial, Trials, vol. 21, pp. 1-12, doi: 10.1186/s13063-019-3758-9. Attached Files Name Description MIMEType Size Downloads Title Vitamin D supplementation compared to placebo in people with First Episode psychosis - Neuroprotection Design (DFEND): a protocol for a randomised, double-blind, placebo-controlled, parallel-group trial Author(s) Gaughran, Fiona Stringer, Dominic Berk, Michael orcid.org/0000-0002-5554-6946 Smith, Shubulade Taylor, David Whiskey, Eromona Landau, Sabine Murray, Robin McGuire, Philip Gardner-Sood, Poonam Wojewodka, Gabriella Ciufolini, Simone Jordan, Harriet Clarke, Jessie Allen, Lauren Krivoy, Amir Stubbs, Brendon Lowe, Philippa Arbuthnott, Maurice Rathod, Shanaya Boardman, Andrew Firdosi, Mudasir McGrath, John J. Journal name Trials Volume number 21 Article ID 14 Start page 1 End page 12 Total pages 12 Publisher BMC Place of publication London, Eng. Publication date 2020-01 ISSN 1745-6215 Keyword(s) Science & Technology Life Sciences & Biomedicine Medicine, Research & Experimental Research & Experimental Medicine Psychosis First episode Vitamin D 25OHD Randomised controlled trial Positive and Negative Syndrome Scale Mental health DEPRESSION RATING-SCALE D DEFICIENCY GLOBAL ASSESSMENT METABOLIC SYNDROME MENTAL-ILLNESS SCHIZOPHRENIA METAANALYSIS VALIDITY RISK RELIABILITY Summary Background: People experiencing their first episode of psychosis are often deficient in vitamin D. Observational studies have reported an association between low vitamin D concentrations and poorer subsequent health outcomes in psychosis. A vitamin D deficiency in neonates and children has been linked to a later increased risk of schizophrenia and psychotic-like experiences. This trial aims to examine the effect of high-dose vitamin D supplementation on outcomes in early psychosis. We hypothesise that vitamin D supplementation will be associated with better mental health outcomes. Methods/design: The DFEND study is a multicentre double-blind placebo-controlled parallel-group trial of vitamin D supplementation in people with early psychosis. Patients with an ICD-10 diagnosis of functional psychosis will be randomised in a 1:1 ratio to receive either 120,000 IU/month of vitamin D (cholecalciferol) or a matched placebo for 6 months. The primary outcome is the total Positive and Negative Syndrome Scale (PANSS) score at the 6-month follow-up for all patients. Secondary outcomes include assessment of mood (Calgary Depression Scale), general function (Global Assessment of Functioning), cardiovascular risk (body mass index, waist circumference, C-reactive protein, cholesterol and HbA1c) and vitamin D levels at the 6-month follow-up. Additionally, 3- and 6-month total PANSS scores will be analysed for those with inadequate vitamin D levels at the baseline. Discussion: The DFEND study is the first trial to examine whether vitamin D supplementation in early psychosis is associated with better mental health outcomes. The findings of this study may help to resolve the clinical equipoise regarding the benefits and cost-effectiveness of routine vitamin D supplementation in people with psychosis.  Language eng DOI 10.1186/s13063-019-3758-9 Indigenous content off Field of Research 110999 Neurosciences not elsewhere classified 1102 Cardiorespiratory Medicine and Haematology 1103 Clinical Sciences Socio Economic Objective 920410 Mental Health HERDC Research category C1 Refereed article in a scholarly journal Free to Read? Yes Persistent URL http://hdl.handle.net/10536/DRO/DU:30133493 Document type: Journal Article Collections: Faculty of Health School of Medicine Open Access Collection Related Links Link Description Link to full-text (open access)     Unless expressly stated otherwise, the copyright for items in DRO is owned by the author, with all rights reserved. Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au. Versions Version Filter Type Fri, 10 Jan 2020, 10:26:21 EST Sat, 11 Jan 2020, 04:00:17 EST Sun, 12 Jan 2020, 17:44:44 EST Sat, 25 Jan 2020, 01:32:13 EST Sat, 14 Mar 2020, 01:30:12 EST Fri, 03 Apr 2020, 20:39:17 EST Tue, 19 May 2020, 06:03:46 EST Thu, 21 May 2020, 09:42:53 EST Thu, 21 May 2020, 09:49:31 EST Thu, 21 May 2020, 09:50:27 EST Thu, 21 May 2020, 09:57:01 EST Filtered Full Citation counts:   Cited 2 times in TR Web of Science Cited 4 times in Scopus Search Google Scholar Access Statistics: 152 Abstract Views, 2 File Downloads  -  Detailed Statistics Created: Fri, 03 Apr 2020, 20:39:17 EST

Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au.