Mayur Garg1, Ourania Rosella2, Gennaro Rosella3, Yunqiu Wu4, John S Lubel5, Peter R Gibson6. 1. Department of Gastroenterology, Eastern Health, 8 Arnold St, Box Hill, Victoria 3128, Australia; Eastern Health Clinical School, Monash University, 5 Arnold St, Box Hill, Victoria 3128, Australia. Electronic address: Mayur.Garg@monash.edu. 2. Department of Gastroenterology, Alfred Hospital, 55 Commercial Rd, Melbourne, Victoria 3004, Australia; Department of Medicine, Monash University, 55 Commercial Rd, Melbourne, Victoria 3004, Australia. Electronic address: Ourania.rosella@monash.edu. 3. Department of Gastroenterology, Alfred Hospital, 55 Commercial Rd, Melbourne, Victoria 3004, Australia; Department of Medicine, Monash University, 55 Commercial Rd, Melbourne, Victoria 3004, Australia. Electronic address: Gennarino.Rosella@monash.edu. 4. Eastern Health Clinical School, Monash University, 5 Arnold St, Box Hill, Victoria 3128, Australia. Electronic address: karenwu0908@gmail.com. 5. Department of Gastroenterology, Eastern Health, 8 Arnold St, Box Hill, Victoria 3128, Australia; Eastern Health Clinical School, Monash University, 5 Arnold St, Box Hill, Victoria 3128, Australia. Electronic address: John.Lubel@monash.edu. 6. Department of Gastroenterology, Alfred Hospital, 55 Commercial Rd, Melbourne, Victoria 3004, Australia; Department of Medicine, Monash University, 55 Commercial Rd, Melbourne, Victoria 3004, Australia. Electronic address: Peter.Gibson@monash.edu.
Abstract
BACKGROUND & AIMS:Vitamin D at serum 25(OH)D concentrations above 100 nmol/L is associated with disease remission in patients with IBD, suggesting targeted dosing might be anti-inflammatory. This study aimed to assess the effectiveness, safety and predictors of a 12-week regimen of vitamin D supplementation to achieve such a target in patients with active disease. METHODS: In a pilot study, patients with active colitis and a serum 25(OH)D concentration <75 nmol/L were prescribedoral liquid vitamin D supplementation over 12 weeks using a specific protocol with dose adjusted 4-weekly to aim for a target level of 100-125 nmol/L. RESULTS: Five patients each with Crohn's colitis or ulcerative colitis (UC) had mean 25(OH)D concentration 52 (range 27-73 nmol/L). Five reached the targeted level and four 89-95 nmol/L. One withdrew after 4 weeks (88 nmol/L). Target dose was met only in those with BMI <30 kg/m2 and total dose inversely correlated with initial serum 25(OH)D. One patient had developed a high level at 8 weeks (146 nmol/L) and another new hypercalciuria. There were no serious adverse events attributable to the therapy. Clinical disease activity consistently declined, but faecal calprotectin and circulating markers of inflammation did not. CONCLUSIONS: A specified oral vitamin D regimen successfully and safely achieved target or near-target levels, improved symptom-based activity scores, but did not alter objective measures of intestinal or systemic inflammation. A modified version of this dose-escalating regimen would be suitable for a randomised placebo-controlled trial, but does require regular safety monitoring.
RCT Entities:
BACKGROUND & AIMS:Vitamin D at serum 25(OH)D concentrations above 100 nmol/L is associated with disease remission in patients with IBD, suggesting targeted dosing might be anti-inflammatory. This study aimed to assess the effectiveness, safety and predictors of a 12-week regimen of vitamin D supplementation to achieve such a target in patients with active disease. METHODS: In a pilot study, patients with active colitis and a serum 25(OH)D concentration <75 nmol/L were prescribed oral liquid vitamin D supplementation over 12 weeks using a specific protocol with dose adjusted 4-weekly to aim for a target level of 100-125 nmol/L. RESULTS: Five patients each with Crohn's colitis or ulcerative colitis (UC) had mean 25(OH)D concentration 52 (range 27-73 nmol/L). Five reached the targeted level and four 89-95 nmol/L. One withdrew after 4 weeks (88 nmol/L). Target dose was met only in those with BMI <30 kg/m2 and total dose inversely correlated with initial serum 25(OH)D. One patient had developed a high level at 8 weeks (146 nmol/L) and another new hypercalciuria. There were no serious adverse events attributable to the therapy. Clinical disease activity consistently declined, but faecal calprotectin and circulating markers of inflammation did not. CONCLUSIONS: A specified oral vitamin D regimen successfully and safely achieved target or near-target levels, improved symptom-based activity scores, but did not alter objective measures of intestinal or systemic inflammation. A modified version of this dose-escalating regimen would be suitable for a randomised placebo-controlled trial, but does require regular safety monitoring.
Authors: Joana C Branco; Mariana F Cardoso; Vera Anapaz; Luís Carvalho Lourenço; Ana Maria Oliveira; Catarina Graça Rodrigues; Liliana Santos; Jorge A Reis Journal: GE Port J Gastroenterol Date: 2018-05-14
Authors: Mayur Garg; Simon G Royce; Chris Tikellis; Claire Shallue; Pavel Sluka; Hady Wardan; Patrick Hosking; Shaun Monagle; Merlin Thomas; John S Lubel; Peter R Gibson Journal: Therap Adv Gastroenterol Date: 2019-01-18 Impact factor: 4.409
Authors: Laura Gisbert-Ferrándiz; Jesús Cosín-Roger; Carlos Hernández; Dulce C Macias-Ceja; Dolores Ortiz-Masiá; Pedro Salvador; Juan V Esplugues; Joaquín Hinojosa; Francisco Navarro; Sara Calatayud; María D Barrachina Journal: Nutrients Date: 2020-04-01 Impact factor: 5.717