scholarly journals Protocol for an open-label feasibility study for a randomised controlled trial of vitamin D supplementation in Crohn’s Disease patients with vitamin D deficiency: D-CODE Feasiblity study

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Jane Fletcher ◽  
Emma Bedson ◽  
Michaela Brown ◽  
Martin Hewison ◽  
Amelia Swift ◽  
...  
Keyword(s):  
Vitamin D ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Vitamin D Deficiency ◽  
Feasibility Study ◽  
Controlled Trial ◽  
List Type ◽  
Open Label ◽  
Inflammatory Bowel ◽  
Randomised Controlled

Abstract Background Crohn's disease (CD) is a principal form of inflammatory bowel disease, affecting approximately 1 in every 650 people in the UK. Vitamin D deficiency is common in approximately 57.7% of CD patients; with anaemia occurring in about 43% of patients. There is growing evidence that supplementing CD patients who are vitamin D deficient may be effective in reducing the severity of CD symptoms and reducing iron-deficiency anaemia. Nevertheless, National Institute for Health and Care Excellence guidance regarding the management of CD does not address vitamin D deficiency in these patients. The aims of the study are (1) to determine the prevalence of vitamin D deficiency in adults with CD in Birmingham, UK and (2) to assess the feasibility of conducting a multi-site randomised controlled trial in adult patients with CD and vitamin D deficiency. Methods D-CODE consists of two parts—a screening study and an open-label randomised controlled feasibility study. Vitamin D screening Three hundred patients, 18 years or older with CD will have a dried blood spot test to measure vitamin D levels. Dietary and sun exposure data will be collected. Eligible patients with low levels of vitamin D will be invited to participate in the feasibility study. Feasibility study Fifty participants with CD and vitamin D deficiency will be randomised to receive either a low (400 IU daily for 24 weeks) or high (3200 IU daily for 12 weeks then vitamin D3 800 IU daily for 12 weeks) dose of vitamin D3 oral supplementation. Patient-reported outcomes (Inflammatory Bowel Disease Questionnaire, EQ-5D-5L and Crohn’s Disease Activity Index Score) will be collected at weeks 0 and 24. Biochemical monitoring will take place at weeks 0, 12 and 24 and will measure 25-hydroxyvitamin D, corrected calcium, albumin, parathyroid hormone, hepcidin, other vitamin D metabolites, iron studies and C-reactive protein. Faecal calprotectin will be measured at weeks 0 and 24. Discussion A key aspect of D-CODE is the identification of vitamin D deficiency prior to supplementation. It is hoped that this feasibility study will lead to a definitive trial that will investigate the benefits of treating vitamin D deficiency in patients with CD. Trial registration The trial has been registered with EudraCT number 2018-003910-42, ClinicalTrials.gov identifier NCT03718182 and ISRCTN number 15717783.

Azithromycin and metronidazole versus metronidazole-based therapy for the induction of remission in mild to moderate paediatric Crohn’s disease : a randomised controlled trial

Gut ◽  
2018 ◽  
Vol 68 (2) ◽  
pp. 239-247 ◽  
Author(s):  
Arie Levine ◽  
Michal Kori ◽  
Jarek Kierkus ◽  
Rotem Sigall Boneh ◽  
Malgorzata Sladek ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Randomised Controlled Trial ◽  
Crohn's Disease ◽  
Activity Index ◽  
Controlled Trial ◽  
Open Label ◽  
Faecal Calprotectin ◽  
Group 2 ◽  
Randomised Controlled ◽  
Group 1

ObjectiveCrohn’s disease (CD) pathogenesis associated with dysbiosis and presence of pathobionts in the lumen, intracellular compartments and epithelial biofilms. Azithromycin is active in all three compartments. Our goal was to evaluate if azithromycin-based therapy can improve response and induce remission compared with metronidazole alone in paediatric CD.DesignThis blinded randomised controlled trial allocated children 5–18 years with 10<Pediatric Crohn’s Disease Activity Index (PCDAI)≤40 to azithromycin 7.5 mg/kg, 5 days/week for 4 weeks and 3 days/week for another 4 weeks with metronidazole 20 mg/kg/day (group 1) or metronidazole alone (group 2), daily for 8 weeks. Failures from group 2 were offered azithromycin as open label. The primary end point was response defined by a decrease in PCDAI>12.5 or remission using intention to treat analysis.Results73 patients (mean age 13.8±3.1 years) were enrolled, 35 to group 1 and 38 to group 2. Response and remission rates at week 8 were identical 23/35 (66%) in group 1 and 17/38 (45%) and 15/38 (39%) in group 2 (P=0.07 and P=0.025, respectively). The needed to treat for remission was 3.7. Faecal calprotectin declined significantly in group 1 (P=0.003) but not in group 2 (p=0.33), and was lower at week 8 (P=0.052). Additional therapy was required in 6/35(17%) from group 1 versus 16/38(42%) in group 2 (P=0.027) by week 8. Among 12 failures in group 2, open-label azithromycin led to remission in 10/12 (83%).ConclusionsThe combination of azithromycin and metronidazole failed to improve response but was superior for induction of remission and reduction in calprotectin.Trial registration numberNCT01596894.

scholarly journals Laparoscopic bowel resection combined with infliximab treatment (LaRIC) versus infliximab for terminal ileitis in Crohn’s disease: a randomised, controlled, open-label trial

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e038429
Author(s):  
Xiuxiu Hao ◽  
Tienan Feng ◽  
Yang Yang ◽  
Yuan Shi ◽  
Ran Jing ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Remission ◽  
Bowel Resection ◽  
Controlled Trial ◽  
Infliximab Treatment ◽  
Open Label ◽  
Endoscopic Remission ◽  
Laparoscopic Bowel Resection ◽  
Randomised Controlled

IntroductionCrohn’s disease is a chronic inflammatory disease of the gastrointestinal tract with an increasing incidence and prevalence worldwide. The early use of anti-­tumour necrosis factor agents, such as infliximab, in patients with an aggressive form of Crohn’s disease has become part of routine practice. However, infliximab has limitations, and early surgery might benefit patients more. The objective of this study was to compare laparoscopic bowel resection with infliximab treatment in patients with moderately or severely active Crohn’s disease with respect to endoscopic remission. The laparoscopic bowel resection combined with infliximab treatment trial is the first randomised controlled trial to demonstrate if early surgery can improve the outcome of patients with Crohn’s disease with limited non-stricturing disease treated with infliximab.Methods and analysisThis is a randomised, open-label, controlled trial at Renji Hospital. In this study, a total of 106 adult patients aged 18–80 years with moderately or severely active and steroid-dependent or steroid-resistant Crohn’s disease of the distal ileum will be randomly assigned in a 1:1 ratio to the control and surgery groups. The primary outcome is 12-month endoscopic remission measured by the Simple Endoscopic Score for Crohn’s Disease in the control group and the Rutgeerts score in the surgery group. The secondary outcomes are clinical remission, surgery rate, quality of life, Crohn’s disease-related medical costs and Crohn’s disease-related morbidity. The patients will be followed up every 6 months after randomisation through intestinal magnetic resonance enterography and colonoscopy for either 3 years or until clinical remission.Ethics and disseminationAll participants will provide informed consent. The protocol has been approved by the Medical Ethical Committee of the Academic Medical Center in Shanghai (No KY2019-180). Results will be disseminated through peer-reviewed journals and scientific conference presentations.Trial registration numberChiCTR2000029323.

scholarly journals P436 Evaluation of targeted vitamin D supplementation regimen in postoperative patients with Crohn’s disease

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S396-S396
Author(s):  
Y LI ◽  
L Zheng ◽  
D Yao ◽  
Z Zhou ◽  
B Liu ◽  
...  
Keyword(s):  
Vitamin D ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Controlled Trial ◽  
Vitamin D Supplementation ◽  
Oral Vitamin ◽  
Serious Adverse Events ◽  
Faecal Calprotectin ◽  
Randomised Controlled ◽  
High Level

Abstract Background Vitamin D with a serum 25(OH)D concentration above 100 nmol/l was associated with disease remission in patients with IBD and suggested that targeted administration may be an anti-inflammatory drug. This study was designed to assess the effectiveness, safety, and predictive measures of a vitamin D regimen in postoperative patients with Crohn’s disease to achieve the above goals. Methods In a prospective study, patients with Crohn’s disease and serum 25(OH)D concentrations &lt;75 nmol / L were prescribed an oral vitamin D supplement at a dose of one year, and adjusted 4-weekly to aim for a serum 25(OH)D level of 100–125 nmol/l. Results Thirty-two postoperative patients with Crohn’s colitis had an average 25(OH)D concentration of 51.5 (range 25–74 nmol / L). 25 patients reached the target level and six patients reached 90–94 nmol / L. Because of the reoperation, one patient withdrew in 6 months. Patients with BMI &lt;30 kg / m2 could reach the target dose (p = 0.006), and the total dose was negatively correlated with the initial serum 25(OH)D (Spearman r = 0.86, p = 0.002). One patient developed a high level (146 nmol/L) at 2 months and the other had new hypercalciuria. There are no serious adverse events attributable to treatment. Clinical disease activity continued to decline (p = 0.015), but faecal calprotectin (p = 0.264), inflammatory cycle markers (p = 0.513) and Rutgeerts score (p = 0.428) did not decrease. Conclusion Specific oral vitamin D regimens can successfully and safely reach or approach target levels, improve symptom-based activity scores, but do not alter objective indicators of intestinal or systemic inflammation. A modified version of this dose-escalation protocol is suitable for randomised placebo-controlled trials, and the further randomised controlled trial was needed.

scholarly journals Prevalence of Vitamin D Deficiency and Its Relationship with Clinical Outcomes in Patients with Fibromyalgia: a Systematic Review of the Literature

2022 ◽  
Vol 4 (1) ◽  
Author(s):  
Omar M. E. Ali
Keyword(s):  
Vitamin D ◽  
Vitamin D Deficiency ◽  
Patient Flow ◽  
Controlled Trial ◽  
Cost Effective ◽  
Therapeutic Benefit ◽  
Vitamin D Supplementation ◽  
Effective Interventions ◽  
Randomised Controlled ◽  
And Control

Abstract Fibromyalgia is a debilitating chronic condition which poses a therapeutic challenge to the clinician. With a large backlog in patient flow subsequent to the COVID-19 pandemic and rising numbers of patients with post-acute sequelae of COVID-19 (PASC) presenting with fibromyalgia-like clinical features, there is an increasingly pressing need to identify broad cost-effective interventions. Low levels of vitamin D have previously been reported in patients with fibromyalgia, though any causative link has been difficult to establish. A systematic literature review on the association between vitamin D deficiency and fibromyalgia was performed examining retrospective evidence both for and against an association between vitamin D deficiency (VDD) and fibromyalgia and evaluating the therapeutic benefit from supplementation. A group of six studies were selected based on relevance, use of controls, quality of research and citations. Four primary studies assessing the prevalence of VDD in fibromyalgia patients versus controls were evaluated with a total 3,496 subjects. Three included females only and one larger study assessed males. Two (n = 313) concluded the presence of a statistically significant association, and two (n = 161) found none. Two randomised controlled trials assessing the effect of vitamin D supplementation in a total of 80 subjects found conflicting results, with pain reduction in one and none in the other. It is likely there exists an association between VDD deficiency and fibromyalgia in a large subset of patients, although establishing primary causation is difficult. There is a need for larger randomised controlled trial designs with more effective comparison with healthy subjects and control for confounding factors. Given VDD is a major problem in the general population, we recommend supplementation be recommended by healthcare professionals to fibromyalgia patients for the purpose of maintaining bone health given their potentially increased susceptibility to developing deficiency and its sequelae.

scholarly journals P652 Underweight patients with Crohn’s disease and without vitamin D supplementation are at high risk of vitamin D deficiency

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S536-S537
Author(s):  
D Vranesic Bender ◽  
V Domislović ◽  
M Brinar ◽  
D Ljubas Kelečić ◽  
I Karas ◽  
...  
Keyword(s):  
Vitamin D ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Vitamin D Deficiency ◽  
Vitamin D Supplementation ◽  
Lower Range ◽  
Total Study Population ◽  
Vitamin D Levels ◽  
Significant Difference ◽  
Underweight Patients

Abstract Background Vitamin D deficiency is frequently present in inflammatory bowel disease (IBD) with a higher incidence in Crohn’s disease (CD) than in ulcerative colitis (UC). Given the involvement of the alimentary tract, many factors can contribute to vitamin D deficiency. The aim of the study was to investigate the association of vitamin D deficiency according to body mass index (BMI) in adult patients with IBD. Methods A cross-sectional study was conducted on a cohort of 152 IBD patients, 68.1% (n = 104) CD and 31.9% (n = 48) UC. The mean age of the total study population was 37.3±11.8 years and 57.3% (n = 87) were male. All patients were adult, Caucasian and without vitamin D supplementation. Patients were recruited during one year period. Results Out of all IBD patients, 60.5% (n = 92) had vitamin D deficiency, 32.2%, (n = 49) insufficiency and 7.2% (n = 11) sufficiency. According to BMI categories there were 12.5% (n = 19) obese patients, 27.6% (n = 42) overweight, 51.3% (n = 78) with normal body weight, and 8.6% (n = 13) underweight. There was a significant difference in vitamin D levels according to different BMI categories in terms of underweight patients having the lowest vitamin D levels; underweight 29.84±11.94 mmol/l, normal 46 ± 20.7 mmol/l, overweight 48±20.1 mmol/l, obese 51±15.3 mmol/l. In addition, there was a significant correlation of vitamin D levels and BMI values (Rho = 0.212, 95% CI 0.069–0.345, p = 0.004), which was more clearly observed in the lower range of BMI values (Figure 1). Male underweight patients had lower levels of vitamin D compared with female patients (26.6 ± 9 vs. 34.7 ± 5.6, p &lt; 0.05). Both patients with CD and UC had significant positive correlation of vitamin D levels and BMI values (UC Rho=0.40, 95% CI 0.16–0.59, p = 0.001, UC Rho = 0.27, 95% CI 0.01–0.05, p = 0.044). However, when comparing vitamin D levels according to phenotype, a significant difference in vitamin D levels was observed in underweight CD (28.4 ± 11.1) comparing to underweight UC patients (40.6 ± 10.6), p &lt; 0.05. In logistic regression analysis, CD phenotype was risk factor for vitamin D deficiency (OR 2.18 95% CI 1.01–4.72, β = 1.22, p = 0.04). Conclusion Our results on untreated IBD patients show a high proportion of vitamin D deficiency both in CD and UC, and significant correlation of vitamin D levels and BMI values, especially in the lower range of BMI values. Moreover, underweight CD patients have lower vitamin D levels comparing to UC. This suggests the need for regular vitamin D monitoring and supplementation especially in IBD patients at risk.

scholarly journals Vitamin D in schizophrenia and depression: a clinical review

2019 ◽  
Vol 25 (4) ◽  
pp. 240-248 ◽  
Author(s):  
John Lally ◽  
Fiona Gaughran
Keyword(s):  
Vitamin D ◽  
Mental Disorders ◽  
Physical Health ◽  
Vitamin D Deficiency ◽  
Vitamin D Supplementation ◽  
Research Centre ◽  
List Type ◽  
Potential Association ◽  
Health And Social Care ◽  
Randomised Controlled

SUMMARYEvidence from preclinical and clinical studies supports a role for vitamin D deficiency in many mental disorders. In this review, we discuss the role of vitamin D in the aetiology and treatment of schizophrenia and depression and their physical health comorbidities. Although observational studies support a potential association between vitamin D and schizophrenia and depression, sufficient high-quality evidence from clinical trials does not yet exist to establish a place for vitamin D supplementation in optimising clinical response or promoting physical health. Completed randomised controlled trials are needed to provide insights into the efficacy and safety of vitamin D in the management of mental disorders.LEARNING OBJECTIVESAfter reading this article you will be able to: •outline the epidemiology of vitamin D deficiency in schizophrenia•describe the associations of vitamin D with schizophrenia and depression•know how to assess, and consider treatment for, vitamin D deficiency.DECLARATION OF INTERESTF.G. has received support or honoraria for CME, advisory work and lectures from Bristol-Myers Squibb, Janssen, Lundbeck, Otsuka, Roche and Sunovion, and has a family member with professional links to Lilly and GSK, including shares. She is in part funded by the National Institute for Health Research's (NIHR) Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King's College London and the South London Collaboration for Leadership in Applied Health Research & Care Funding scheme, and by the Maudsley Charity. The views expressed in this article are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.

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