Department of Pharmacology, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, India.
Community Medicine and Family Medicine, All India Institute of Medical Sciences, Kalyani, West Bengal, India.
BMJ Open. 2023 Aug 29;13(8):e066361. doi: 10.1136/bmjopen-2022-066361.
The study aimed to compare early molecular response (EMR) rates at 3 months of imatinib therapy with and without vitamin D supplementation in patients newly diagnosed with chronic-phase chronic myeloid leukaemia (CML-CP). The secondary objective was to assess the effects of vitamin D on complete haematological response (CHR) and its safety.
Double-blind, placebo-controlled, exploratory randomised trial.
Tertiary care hospital in northern India.
Treatment-naive patients with chronic phase chronic myeloid leukaemia (n=62) aged >12 years were recruited from January 2020 to January 2021. Patients with progressive disease, pregnancy and hypercalcaemia were excluded.
Oral vitamin D supplementation (60 000 IU) or matched placebo was given once weekly for an initial 8 weeks along with imatinib after randomisation with 1:1 allocation ratio.
The primary outcome was to compare EMR (defined as transcript level ≤10%, international scale) at 3 months. The secondary outcomes were to compare effect of the intervention on CHR, correlation of 25(OH)2D levels with treatment response and safety according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.
At baseline, 14.5% of the patients had normal vitamin D levels. EMR at 3 months was attained in 24 patients (82.7%) of the vitamin D group and 21 (75%) of the placebo group (OR 1.6, 95% CI 0.37 to 7.37, p=0.4). A significant difference in vitamin D levels from baseline to the end of study was observed. Patients with vitamin D supplementation did not achieve higher CHR in comparison with placebo (OR 1.3, 95% CI 0.25 to 7.23, p=1.0). Vitamin D3 levels were not significantly correlated with levels. No dose-limiting toxicities were observed.
Vitamin D levels were low among patients with CML-CP in this study. Vitamin D 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 supplementation in these patients.
CTRI/2019/09/021164.
本研究旨在比较新诊断为慢性期慢性髓系白血病（CML-CP）患者在接受伊马替尼治疗 3 个月时添加与不添加维生素 D 补充剂的早期分子反应（EMR）率。次要目的是评估维生素 D 对完全血液学反应（CHR）的影响及其安全性。
双盲、安慰剂对照、探索性随机试验。
印度北部的一家三级护理医院。
招募了 2020 年 1 月至 2021 年 1 月期间年龄大于 12 岁、未经治疗的慢性期 CML 患者（n=62）。排除了进展性疾病、妊娠和高钙血症的患者。
每周一次口服给予维生素 D 补充剂（60000IU）或匹配的安慰剂，与伊马替尼一起使用，在随机分组后最初 8 周内进行，分配比例为 1:1。
主要结局是比较 3 个月时的 EMR（定义为 转录水平≤10%，国际标准）。次要结局是比较干预对 CHR 的影响，根据常见不良事件术语标准（CTCAE）版本 5 评估 25（OH）2D 水平与治疗反应和安全性的相关性。
在基线时，14.5%的患者维生素 D 水平正常。维生素 D 组有 24 名患者（82.7%）和安慰剂组有 21 名患者（75%）在 3 个月时达到 EMR（OR 1.6，95%CI 0.37 至 7.37，p=0.4）。从基线到研究结束时，维生素 D 水平有显著差异。与安慰剂相比，接受维生素 D 补充剂的患者并未获得更高的 CHR（OR 1.3，95%CI 0.25 至 7.23，p=1.0）。维生素 D3 水平与 水平无显著相关性。未观察到剂量限制毒性。
在本研究中，CML-CP 患者的维生素 D 水平较低。伊马替尼治疗中添加维生素 D 补充剂对 EMR 或 CHR 没有显著影响。可以进行进一步的临床试验，以评估这些患者中维生素 D 补充剂的有效剂量和持续时间。
CTRI/2019/09/021164。
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