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

Primary Purpose

Vitamin D Deficiency

Status
Unknown status
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
Vitamin D3
Sponsored by
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vitamin D Deficiency

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Bangabandhu Sheikh Mujib Medical University (BSMMU)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Vitamin D3

Vitamin D3 placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Plasma Superoxide dismutase (SOD) level
Plasma Superoxide dismutase (SOD) after 26 weeks of vitamin D3 supplementation
Plasma Catalase (CAT) level
Plasma Catalase (CAT) after 26 weeks of vitamin D3 supplementation.

Secondary Outcome Measures

Full Information

First Posted
April 22, 2019
Last Updated
April 27, 2019
Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
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1. Study Identification

Unique Protocol Identification Number
NCT03931889
Brief Title
Effects of Vitamin D3 Supplementation on Antioxidant Enzymes Status in Vitamin D3 Deficient Asthma COPD Overlap (ACO) Patients
Official Title
Effects of Vitamin D3 Supplementation on Antioxidant Enzymes Status in Vitamin D3 Deficient Asthma COPD Overlap (ACO) Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Anticipated)
Study Completion Date
June 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

4. Oversight

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.
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D3
Arm Type
Active Comparator
Arm Description
Cholecalciferol 80,000 IU (2 capsules of 40,000 IU) per oral per week for consecutive 26 weeks.
Arm Title
Vitamin D3 placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (2 capsules) per oral per week for consecutive 26 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3
Intervention Description
Cap. Cholecalciferol 40,000 IU
Primary Outcome Measure Information:
Title
Plasma Superoxide dismutase (SOD) level
Description
Plasma Superoxide dismutase (SOD) after 26 weeks of vitamin D3 supplementation
Time Frame
26th week of vitamin D3 supplementation
Title
Plasma Catalase (CAT) level
Description
Plasma Catalase (CAT) after 26 weeks of vitamin D3 supplementation.
Time Frame
26th week of vitamin D3 supplementation

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taskina Ali, MBBS,M.Phil
Organizational Affiliation
BSMMU, Shahbagh, Dhaka, Bangladesh
Official's Role
Study Director
Facility Information:
Facility Name
Bangabandhu Sheikh Mujib Medical University (BSMMU)
City
Dhaka
ZIP/Postal Code
1000
Country
Bangladesh

12. IPD Sharing Statement

Plan to Share IPD
No

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

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