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
Abstract 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 b...
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| Format: | Article |
| Language: | English |
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BMC
2020-01-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-019-3758-9 |
| _version_ | 1818645549848461312 |
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| author | Fiona Gaughran Dominic Stringer Michael Berk Shubulade Smith David Taylor Eromona Whiskey Sabine Landau Robin Murray Philip McGuire Poonam Gardner-Sood Gabriella Wojewodka Simone Ciufolini Harriet Jordan Jessie Clarke Lauren Allen Amir Krivoy Brendon Stubbs Philippa Lowe Maurice Arbuthnott Shanaya Rathod Andrew Boardman Mudasir Firdosi John J. McGrath |
| author_facet | Fiona Gaughran Dominic Stringer Michael Berk Shubulade Smith David Taylor Eromona Whiskey Sabine Landau Robin Murray Philip McGuire Poonam Gardner-Sood Gabriella Wojewodka Simone Ciufolini Harriet Jordan Jessie Clarke Lauren Allen Amir Krivoy Brendon Stubbs Philippa Lowe Maurice Arbuthnott Shanaya Rathod Andrew Boardman Mudasir Firdosi John J. McGrath |
| author_sort | Fiona Gaughran |
| collection | DOAJ |
| description | Abstract 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. Trial registration ISRCTN, ISRCTN12424842. Registered on 25 February 2015. |
| first_indexed | 2024-12-17T00:32:31Z |
| format | Article |
| id | doaj.art-9818ac87758f4b8d87af5d844071e6d3 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-17T00:32:31Z |
| publishDate | 2020-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-9818ac87758f4b8d87af5d844071e6d32022-12-21T22:10:14ZengBMCTrials1745-62152020-01-0121111210.1186/s13063-019-3758-9Vitamin 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 trialFiona Gaughran0Dominic Stringer1Michael Berk2Shubulade Smith3David Taylor4Eromona Whiskey5Sabine Landau6Robin Murray7Philip McGuire8Poonam Gardner-Sood9Gabriella Wojewodka10Simone Ciufolini11Harriet Jordan12Jessie Clarke13Lauren Allen14Amir Krivoy15Brendon Stubbs16Philippa Lowe17Maurice ArbuthnottShanaya Rathod18Andrew Boardman19Mudasir Firdosi20John J. McGrath21Department of Psychosis Studies, King’s College London, Institute of Psychiatry, Psychology and NeuroscienceDepartment of Biostatistics and Health Informatics, King’s College London, Institute of Psychiatry, Psychology and NeuroscienceDeakin University and Barwon HealthDepartment of Psychosis Studies, King’s College London, Institute of Psychiatry, Psychology and NeuroscienceSouth London and Maudsley NHS Foundation TrustDepartment of Psychosis Studies, King’s College London, Institute of Psychiatry, Psychology and NeuroscienceDepartment of Biostatistics and Health Informatics, King’s College London, Institute of Psychiatry, Psychology and NeuroscienceDepartment of Psychosis Studies, King’s College London, Institute of Psychiatry, Psychology and NeuroscienceDepartment of Psychosis Studies, King’s College London, Institute of Psychiatry, Psychology and NeuroscienceDepartment of Psychosis Studies, King’s College London, Institute of Psychiatry, Psychology and NeuroscienceDepartment of Psychosis Studies, King’s College London, Institute of Psychiatry, Psychology and NeuroscienceDepartment of Psychosis Studies, King’s College London, Institute of Psychiatry, Psychology and NeuroscienceDepartment of Psychosis Studies, King’s College London, Institute of Psychiatry, Psychology and NeuroscienceDepartment of Psychosis Studies, King’s College London, Institute of Psychiatry, Psychology and NeuroscienceDepartment of Psychosis Studies, King’s College London, Institute of Psychiatry, Psychology and NeuroscienceDepartment of Psychosis Studies, King’s College London, Institute of Psychiatry, Psychology and NeuroscienceDepartment of Psychosis Studies, King’s College London, Institute of Psychiatry, Psychology and NeuroscienceCarer Expert and Chair of Trustees, Rethink Mental IllnessClinical Trials Facility, Research Department, Tom Rudd Unit, Moorgreen HospitalCheshire & Wirral Partnership NHS Trust, Churton HouseSouth West London and St George’s Mental Health NHS Trust, Queen Mary’s HospitalQueensland Centre for Mental Health Research, The Park Centre for Mental HealthAbstract 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. Trial registration ISRCTN, ISRCTN12424842. Registered on 25 February 2015.https://doi.org/10.1186/s13063-019-3758-9PsychosisFirst episodeVitamin D25OHDRandomised controlled trialPositive and Negative Syndrome Scale |
| spellingShingle | Fiona Gaughran Dominic Stringer Michael Berk Shubulade Smith David Taylor Eromona Whiskey Sabine Landau Robin Murray Philip McGuire Poonam Gardner-Sood Gabriella Wojewodka Simone Ciufolini Harriet Jordan Jessie Clarke Lauren Allen Amir Krivoy Brendon Stubbs Philippa Lowe Maurice Arbuthnott Shanaya Rathod Andrew Boardman Mudasir Firdosi John J. McGrath 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 Psychosis First episode Vitamin D 25OHD Randomised controlled trial Positive and Negative Syndrome Scale |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Psychosis First episode Vitamin D 25OHD Randomised controlled trial Positive and Negative Syndrome Scale |
| url | https://doi.org/10.1186/s13063-019-3758-9 |
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