About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

378040 studies
in
220 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

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

Clinicaltrials.gov identifier NCT03931889

Recruitment Status Active, not recruiting

First Posted April 30, 2019

Last update posted April 30, 2019

Study Description

Brief summary:

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.

  • Condition or Disease:Vitamin D Deficiency
  • Intervention/Treatment: Dietary Supplement: Vitamin D3
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 40 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Prevention
  • Official Title: Effects of Vitamin D3 Supplementation on Antioxidant Enzymes Status in Vitamin D3 Deficient Asthma COPD Overlap (ACO) Patients
  • Actual Study Start Date: March 2018
  • Estimated Primary Completion Date: June 2019
  • Estimated Study Completion Date: June 2019
Arms and interventions
Arm Intervention/treatment
Active Comparator: Vitamin D3
Cholecalciferol 80,000 IU (2 capsules of 40,000 IU) per oral per week for consecutive 26 weeks.
Dietary Supplement: Vitamin D3
Cap. Cholecalciferol 40,000 IU
Placebo Comparator: Vitamin D3 placebo
Placebo (2 capsules) per oral per week for consecutive 26 weeks.
Dietary Supplement: Vitamin D3
Cap. Cholecalciferol 40,000 IU
Outcome Measures
  • Primary Outcome Measures: 1. Plasma Superoxide dismutase (SOD) level [ Time Frame: 26th week of vitamin D3 supplementation ]
    Plasma Superoxide dismutase (SOD) after 26 weeks of vitamin D3 supplementation
  • 2. Plasma Catalase (CAT) level [ Time Frame: 26th week of vitamin D3 supplementation ]
    Plasma Catalase (CAT) after 26 weeks of vitamin D3 supplementation.
Eligibility Criteria
  • Ages Eligible for Study: 40 to 80 Years (Adult, Older Adult)
  • Sexes Eligible for Study: Male
  • Accepts Healthy Volunteers: Yes
Criteria

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

Contacts and Locations
Contacts
Locations

Bangladesh
Bangabandhu Sheikh Mujib Medical University (BSMMU)
Dhaka

Sponsors and Collaborators

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Investigators

Study Director: Taskina Ali, MBBS,M.Phil BSMMU, Shahbagh, Dhaka, Bangladesh

More Information
  • Responsible Party: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
  • ClinicalTrials.gov Identifier: NCT03931889 History of Changes
  • Other Study ID Numbers: BSMMU/2018/6813
  • First Posted: April 30, 2019 Key Record Dates
  • Last Update Posted: April 30, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Additional relevant MeSH terms: Vitamin D Deficiency