Abstract：
BACKGROUND: Since, Vitamin D [1α,25(OH)2D)] enhances antimicrobial activity of Innate immunity and modulate Adaptive immune responses, simultaneously, so it play a potential role for balanced immune activity against Mycobacterium tuberculosis and restricting tissue injuries within the TB patients.(Chun et al., 2011) 9 We aimed to determine the role of adjunct Vitamin D treatment on the outcome of pulmonary tuberculosis patients and evaluated the effect of Vitamin D administration on Differential Leucocyte Count, Erythrocyte Sedimentation Rate, serum Adenosine deaminase, serum C- reactive protein, Oxygen saturation (SpO2) and Body Weight in Vitamin D deficient pulmonary tuberculosis patients.
METHODS: We conducted a prospective, interventional, randomized, double blind, parallel group, active controlled clinical trial. Newly diagnosed Vitamin D deficient pulmonary tuberculosis patients were randomly assigned to intervention group (received standard anti-tubercular treatment with adjunct Vitamin D3) and control group (received standard anti-tubercular treatment without adjunct Vitamin D3). Total four doses [each dose of 2.5 mg (100000 IU)] of Vitamin D3 were given, orally. First dose was given within 7 days of starting anti-tubercular treatment and second, third, fourth dose were given at 2, 4 and 6 weeks respectively. At the time of enrollment, we measured all baseline characteristics. During follow-up, we measured the study variables and monitored adverse events at 2, 4, 6, 8 and 12 weeks. Our safety parameter was serum corrected calcium level to assess the risk of hypercalcemia.
RESULTS: Total 130 pulmonary TB patients, 65 patients in each group, were analyzed. Our study results showed that decrease in Neutrophil count was statistically significant with small effect sizes at every time point of measurement and increase in Lymphocyte count was statistically significant with small and moderate effect sizes at 4, 6 and 8 week for intervention group than for control group. Decrease in erythrocyte sedimentation rate was statistically significant with small effect sizes at 6 and 8 week, decrease in serum adenosine deaminase and serum C- reactive protein was statistically significant with moderate effect sizes at 4, 6 and 8 week for intervention group than for control group. Increase in Oxygen saturation was statistically significant at 4 week with small effect size and increase in body weight was statistically significant with small effect sizes for intervention group than for control group. No case of hypercalcemia was reported.
CONCLUSIONS: Our findings suggest a potential role of adjunctive Vitamin D3 to accelerate resolution of inflammatory responses and improvement in clinical outcomes of pulmonary TB patients.
BACKGROUND: This trial is registered with Clinical Trials Registry - INDIA (http://ctri.nic.in) with CTRI Number - CTRI/2021/11/037914.
UNASSIGNED: Room Number 27, first floor out-patients department (OPD) and inpatient Wards, fourth floor, Department of Respiratory Medicine, Uttar Pradesh University of Medical Sciences, Saifai, Etawah (U.P.), INDIA.
METHODS: We conducted a prospective, interventional, randomized, double blind, parallel group, active controlled clinical trial. Newly diagnosed Vitamin D deficient pulmonary tuberculosis patients were randomly assigned to intervention group (received standard anti-tubercular treatment with adjunct Vitamin D3) and control group (received standard anti-tubercular treatment without adjunct Vitamin D3). Total four doses [each dose of 2.5 mg (100000 IU)] of Vitamin D3 were given, orally. First dose was given within 7 days of starting anti-tubercular treatment and second, third, fourth dose were given at 2, 4 and 6 weeks respectively. At the time of enrollment, we measured all baseline characteristics. During follow-up, we measured the study variables and monitored adverse events at 2, 4, 6, 8 and 12 weeks. Our safety parameter was serum corrected calcium level to assess the risk of hypercalcemia.
RESULTS: Total 130 pulmonary TB patients, 65 patients in each group, were analyzed. Our study results showed that decrease in Neutrophil count was statistically significant with small effect sizes at every time point of measurement and increase in Lymphocyte count was statistically significant with small and moderate effect sizes at 4, 6 and 8 week for intervention group than for control group. Decrease in erythrocyte sedimentation rate was statistically significant with small effect sizes at 6 and 8 week, decrease in serum adenosine deaminase and serum C- reactive protein was statistically significant with moderate effect sizes at 4, 6 and 8 week for intervention group than for control group. Increase in Oxygen saturation was statistically significant at 4 week with small effect size and increase in body weight was statistically significant with small effect sizes for intervention group than for control group. No case of hypercalcemia was reported.
CONCLUSIONS: Our findings suggest a potential role of adjunctive Vitamin D3 to accelerate resolution of inflammatory responses and improvement in clinical outcomes of pulmonary TB patients.
BACKGROUND: This trial is registered with Clinical Trials Registry - INDIA (http://ctri.nic.in) with CTRI Number - CTRI/2021/11/037914.
UNASSIGNED: Room Number 27, first floor out-patients department (OPD) and inpatient Wards, fourth floor, Department of Respiratory Medicine, Uttar Pradesh University of Medical Sciences, Saifai, Etawah (U.P.), INDIA.
摘要：
背景：因为，维生素D[1α，25（OH）2D）]增强先天免疫的抗菌活性并调节适应性免疫反应，同时,因此，它对平衡结核分枝杆菌的免疫活性和限制结核病患者体内的组织损伤具有潜在的作用。（Chun等人。,2011)9我们旨在确定辅助维生素D治疗对肺结核患者预后的作用，并评估维生素D给药对分化白细胞计数的影响，红细胞沉降率,血清腺苷脱氨酶，血清C-反应蛋白,维生素D缺乏肺结核患者的氧饱和度（SpO2）和体重。
方法：我们进行了前瞻性，介入,随机化，双盲,平行组,主动对照临床试验。将新诊断的维生素D缺乏肺结核患者随机分为干预组（接受标准抗结核治疗并辅以维生素D3）和对照组（接受标准抗结核治疗但不辅以维生素D3）。给予维生素D3总共四剂[每剂2.5mg（100000IU）]，orally.在开始抗结核治疗的7天内给予第一剂，第二剂，第三,第四剂分别在第2、4和6周给予。在入学时，我们测量了所有基线特征.随访期间,我们在第2,4,6,8和12周测量了研究变量并监测了不良事件.我们的安全参数是血清校正钙水平，以评估高钙血症的风险。
结果：总共130名肺结核患者，每组65名患者，进行了分析。我们的研究结果表明，在每个测量时间点，中性粒细胞计数的减少具有统计学意义，效应大小较小，而在4、6和8周时，淋巴细胞计数的增加具有统计学意义，效应大小较小和中等，干预组比对照组。在第6周和第8周时，红细胞沉降率的降低具有统计学意义，效应大小较小，与对照组相比,干预组4、6、8周时血清腺苷脱氨酶和血清C-反应蛋白的降低具有统计学意义,且效应大小适中.与对照组相比，干预组在4周时氧饱和度的增加具有统计学意义，效应大小较小，体重的增加具有统计学意义。没有报告高钙血症的病例。
结论：我们的研究结果表明，辅助维生素D3在加速炎症反应消退和改善肺结核患者临床结局方面具有潜在作用。
背景：该试验已在临床试验注册中心-印度（http://ctri。nic.in）与CTRI编号-CTRI/2021/11/037914。
■27号房间，一楼门诊部（OPD）和住院病房，四楼,呼吸内科,北方邦医科大学,赛法伊,Etawah(U.P.),印度
方法：我们进行了前瞻性，介入,随机化，双盲,平行组,主动对照临床试验。将新诊断的维生素D缺乏肺结核患者随机分为干预组（接受标准抗结核治疗并辅以维生素D3）和对照组（接受标准抗结核治疗但不辅以维生素D3）。给予维生素D3总共四剂[每剂2.5mg（100000IU）]，orally.在开始抗结核治疗的7天内给予第一剂，第二剂，第三,第四剂分别在第2、4和6周给予。在入学时，我们测量了所有基线特征.随访期间,我们在第2,4,6,8和12周测量了研究变量并监测了不良事件.我们的安全参数是血清校正钙水平，以评估高钙血症的风险。
结果：总共130名肺结核患者，每组65名患者，进行了分析。我们的研究结果表明，在每个测量时间点，中性粒细胞计数的减少具有统计学意义，效应大小较小，而在4、6和8周时，淋巴细胞计数的增加具有统计学意义，效应大小较小和中等，干预组比对照组。在第6周和第8周时，红细胞沉降率的降低具有统计学意义，效应大小较小，与对照组相比,干预组4、6、8周时血清腺苷脱氨酶和血清C-反应蛋白的降低具有统计学意义,且效应大小适中.与对照组相比，干预组在4周时氧饱和度的增加具有统计学意义，效应大小较小，体重的增加具有统计学意义。没有报告高钙血症的病例。
结论：我们的研究结果表明，辅助维生素D3在加速炎症反应消退和改善肺结核患者临床结局方面具有潜在作用。
背景：该试验已在临床试验注册中心-印度（http://ctri。nic.in）与CTRI编号-CTRI/2021/11/037914。
■27号房间，一楼门诊部（OPD）和住院病房，四楼,呼吸内科,北方邦医科大学,赛法伊,Etawah(U.P.),印度
