跳至主要内容
临床试验/NCT03931889
NCT03931889Unknown不适用

Effects of Vitamin D3 Supplementation on Antioxidant Enzymes Status in Vitamin D3 Deficient Asthma COPD Overlap (ACO) Patients

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
2
主要终点
Plasma Superoxide dismutase (SOD) level

研究概览

简要总结

Asthma-COPD overlap (ACO) is a new entity in the world of respiratory ailments. The respiratory tract of these patients are continuously exposed to oxidants (due to cigarette smoking) causing oxidative stress. Antioxidant enzymes such as, superoxide dismutase (SOD) and catalase (CAT) neutralize these oxidants or free radicals and transform them into safer. Vitamin D is a natural antioxidant which has few evidence of increasing antioxidant enzyme level in COPD and asthma, but not in ACO patients. To evaluate the effects of vitamin D3 supplementation on antioxidant enzymes level in vitamin D3 deficient patients with stable ACO. The randomized controlled trial was conducted in Department of Physiology Bangabandhu Sheikh Mujib Medical University (BSMMU), Shahbag, Dhaka from March 2018 to February 2019. For this study, a total number of 40 vitamin D3 deficient (serum 25 hydroxycholecalceferol <30 ng/ml) male, stable (diagnosed patient, who was not experienced any acute exacerbation, hospitalization, urgent care visits or changes in routine medication within 4 weeks prior to study) patients with ACO of age ≥40 years was selected from the Out Patient Department (OPD) of the National Institute of Diseases of Chest and Hospital (NIDCH) and randomly grouped as A (control) and B (study). Then serum Superoxide dismutase and Catalase level of all the patients was assessed. Along with the standard pharmacological treatment of ACO (according to GOLD criteria), oral vitamin D3 (80,000 IU per week) will be supplied to the patients of the 'Study group' and placebo for 'Control group' for consecutive 26 weeks. At 26th week of follow up, all the study variables were examined. With this, all patients of both the groups were advised to continue ad lib (according to their own choice) diet. The results was expressed as mean±SD and the data was statistically analyzed by SPSS Version 16, using Independent sample 't' test (between two groups) and paired student's 't' test (between paired groups before and after intervention). In the interpretation of results, <0.05 level of probability (p) was accepted as significant.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Stable ACO patients
  • Vitamin D3 deficieny
  • Duration of ACO: 1-4 years

排除标准

  • With acute exacerbation of any pulmonary diseases, as- respiratory tract infection, bronchiectasis,pleural effusion,tuberculosis, interstitial lung disease, pneumonectomy or pulmonary lobectomy.
  • Any cardiac disease.
  • Chronic liver disease
  • Malignancy
  • Use of drugs within 1 month prior to study, as- calcium supplement, Phenytoin, Carbamazepine, Clotrimazole, Rifampicin, Nifedipine, Spironolactone, Ritononavir, Saquinavir, Cyproterone acetate, glucocorticoids, bisphosphonate
  • With biochemical evidence of - uncontrolled diabetes mellitus, renal insufficiency

研究组 & 干预措施

Vitamin D3

Active Comparator

Cholecalciferol 80,000 IU (2 capsules of 40,000 IU) per oral per week for consecutive 26 weeks.

干预措施: Vitamin D3 (Dietary Supplement)

Vitamin D3 placebo

Placebo Comparator

Placebo (2 capsules) per oral per week for consecutive 26 weeks.

干预措施: Vitamin D3 (Dietary Supplement)

结局指标

主要结局

Plasma Superoxide dismutase (SOD) level

时间窗: 26th week of vitamin D3 supplementation

Plasma Superoxide dismutase (SOD) after 26 weeks of vitamin D3 supplementation

Plasma Catalase (CAT) level

时间窗: 26th week of vitamin D3 supplementation

Plasma Catalase (CAT) after 26 weeks of vitamin D3 supplementation.

次要结局

未报告次要终点

研究者

发起方
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr.Maksuda Bintey Mahmud

MD course student, Department of Physiology,BSMMU,Dhaka,Bangladesh

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

研究点 (2)

Loading locations...

相似试验

Effects of Vitamin D3 Supplementation on Antioxidant... | 临床试验