{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T04:55:47Z","timestamp":1777870547222,"version":"3.51.4"},"reference-count":19,"publisher":"BMJ","issue":"8","license":[{"start":{"date-parts":[[2023,8,29]],"date-time":"2023-08-29T00:00:00Z","timestamp":1693267200000},"content-version":"unspecified","delay-in-days":28,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001411","name":"Indian Council of Medical Research","doi-asserted-by":"publisher","award":["MD19DEC0012"],"award-info":[{"award-number":["MD19DEC0012"]}],"id":[{"id":"10.13039\/501100001411","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2023,7,11]]},"published-print":{"date-parts":[[2023,8]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>\n                      The study aimed to compare early molecular response (EMR) rates at 3 months of imatinib therapy with and without vitamin D\n                      <jats:sub>3<\/jats:sub>\n                      supplementation in patients newly diagnosed with chronic-phase chronic myeloid leukaemia (CML-CP). The secondary objective was to assess the effects of vitamin D\n                      <jats:sub>3<\/jats:sub>\n                      on complete haematological response (CHR) and its safety.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>Double-blind, placebo-controlled, exploratory randomised trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>Tertiary care hospital in northern India.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Participants<\/jats:title>\n                    <jats:p>Treatment-naive patients with chronic phase chronic myeloid leukaemia (n=62) aged &gt;12 years were recruited from January 2020 to January 2021. Patients with progressive disease, pregnancy and hypercalcaemia were excluded.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Intervention<\/jats:title>\n                    <jats:p>\n                      Oral vitamin D\n                      <jats:sub>3<\/jats:sub>\n                      supplementation (60\u2009000\u2009IU) or matched placebo was given once weekly for an initial 8 weeks along with imatinib after randomisation with 1:1 allocation ratio.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Primary and secondary outcome measures<\/jats:title>\n                    <jats:p>\n                      The primary outcome was to compare EMR (defined as\n                      <jats:italic>BCR-ABL1<\/jats:italic>\n                      transcript level \u226410%, international scale) at 3 months. The secondary outcomes were to compare effect of the intervention on CHR, correlation of 25(OH)2D\n                      <jats:sub>3<\/jats:sub>\n                      levels with treatment response and safety according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      At baseline, 14.5% of the patients had normal vitamin D\n                      <jats:sub>3<\/jats:sub>\n                      levels. EMR at 3 months was attained in 24 patients (82.7%) of the vitamin D\n                      <jats:sub>3<\/jats:sub>\n                      group and 21 (75%) of the placebo group (OR 1.6, 95%\u2009CI 0.37 to 7.37, p=0.4). A significant difference in vitamin D\n                      <jats:sub>3<\/jats:sub>\n                      levels from baseline to the end of study was observed. Patients with vitamin D\n                      <jats:sub>3<\/jats:sub>\n                      supplementation did not achieve higher CHR in comparison with placebo (OR 1.3, 95%\u2009CI 0.25 to 7.23, p=1.0). Vitamin D3 levels were not significantly correlated with\n                      <jats:italic>BCR-ABL1<\/jats:italic>\n                      levels. No dose-limiting toxicities were observed.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>\n                      Vitamin D\n                      <jats:sub>3<\/jats:sub>\n                      levels were low among patients with CML-CP in this study. Vitamin D\n                      <jats:sub>3<\/jats:sub>\n                      supplementation with imatinib therapy did not have significant effect on EMR or CHR. Further clinical trials could be undertaken to assess the effective dosage and duration of vitamin D\n                      <jats:sub>3<\/jats:sub>\n                      supplementation in these patients.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>CTRI\/2019\/09\/021164.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2022-066361","type":"journal-article","created":{"date-parts":[[2023,8,29]],"date-time":"2023-08-29T13:00:49Z","timestamp":1693314049000},"page":"e066361","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":3,"title":["Safety and efficacy of Vitamin D\n                    <sub>3<\/sub>\n                    supplementation with Imatinib in Chronic Phase- Chronic Myeloid Leukaemia: an Exploratory Randomized Controlled Trial"],"prefix":"10.1136","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9755-0233","authenticated-orcid":false,"given":"Arkapal","family":"Bandyopadhyay","sequence":"first","affiliation":[{"name":"Department of Pharmacology, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6534-2149","authenticated-orcid":false,"given":"Sarika","family":"Palepu","sequence":"additional","affiliation":[{"name":"Community Medicine and Family Medicine, All India Institute of Medical Sciences, Kalyani, West Bengal, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2890-4939","authenticated-orcid":false,"given":"Puneet","family":"Dhamija","sequence":"additional","affiliation":[{"name":"Department of Pharmacology, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, 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