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

NCT03931889 | Unknown

• 1 other identifier: BSMMU/2018/6813
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Vitamin D3

ACTIVE COMPARATOR

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

Dietary Supplement: Vitamin D3

Vitamin D3 placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Vitamin D3

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

Cap. Cholecalciferol 40,000 IU

Vitamin D3; Vitamin D3 placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

Bangabandhu Sheikh Mujib Medical University (BSMMU)

Dhaka, 1000, Bangladesh

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Taskina Ali, MBBS,M.Phil

  BSMMU, Shahbagh, Dhaka, Bangladesh

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD course student, Department of Physiology,BSMMU,Dhaka,Bangladesh

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: April 30, 2019
• Study Start: March 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: April 30, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)