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

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.

Study Overview

• Status: Unknown
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Dietary supplement: Vitamin D3

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bangladesh
  • Dhaka, Bangladesh, 1000
    • Bangabandhu Sheikh Mujib Medical University (BSMMU)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Superoxide dismutase (SOD) level	Plasma Superoxide dismutase (SOD) after 26 weeks of vitamin D3 supplementation	26th week of vitamin D3 supplementation
Plasma Catalase (CAT) level	Plasma Catalase (CAT) after 26 weeks of vitamin D3 supplementation.	26th week of vitamin D3 supplementation

Collaborators and Investigators

• Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Investigators: Study Director: Taskina Ali, MBBS,M.Phil, BSMMU, Shahbagh, Dhaka, Bangladesh

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Anticipated): June 30, 2019
• Study Completion (Anticipated): June 30, 2019

Study Registration Dates

• First Submitted: April 22, 2019
• First Submitted That Met QC Criteria: April 27, 2019
• First Posted (Actual): April 30, 2019

Study Record Updates

• Last Update Posted (Actual): April 30, 2019
• Last Update Submitted That Met QC Criteria: April 27, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: BSMMU/2018/6813

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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