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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2019-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

This Study Include Asthma Chronic Obstructive Pulmonary Disease (COPD) Overlap Patients.Patients Were Vitamin D Deficient.Age Range 40-70 Years, Smokers.Patients Were Advised to Take Either Placebo or Vitamin D3.Lung Functions and Exercise Tolerance Were Assessed at Baseline and at 26th Weeks.

NCT03880734

Asthma-COPD Overlap Syndrome

COMPLETED PHASE2

Impact of Vitamin D3 Administration on Cardiac Autonomic Tone in Asthma Chronic Obstructive Pulmonary Disease(COPD) Overlap Patients

NCT03773809

Asthma-COPD Overlap Syndrome Vitamin D Deficiency Cardiac Autonomic Tone

COMPLETED NA

This Study Include Chronic Obstructive Pulmonary Disease(COPD) Patients . Patients Were Vitamin D Deficient Age Range 40 to 80 Years, Smokers Patients Were Advised to Take Either Placebo or Vitamin D3 . Antioxidant Enzymes Were Assessed at Baseline and at 26th Weeks.

NCT04011930

Chronic Obstructive Pulmonary Disease

UNKNOWN PHASE2

Effect of Vitamin D3 on Lung Function and Exercise Tolerance in COPD Patients

NCT03781895

Stable COPD Patients

COMPLETED PHASE1

Vitamin D Supplementation in Patients With COPD

NCT02122627

Chronic Obstructive Pulmonary Disease

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vitamin D Deficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vitamin D3

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

Group Type ACTIVE_COMPARATOR

Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Cap. Cholecalciferol 40,000 IU

Vitamin D3 placebo

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

Group Type PLACEBO_COMPARATOR

Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Cap. Cholecalciferol 40,000 IU

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vitamin D3

Cap. Cholecalciferol 40,000 IU

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes