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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. (BSMMU)

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ClinicalTrials.gov Identifier: NCT04011930
Recruitment Status : Recruiting
First Posted : July 9, 2019
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Salma Anjum, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Brief Summary:
Vitamin D3 supplementation dose not increase plasma antioxidant enzymes level in COPD patients was the null hypothesis of the research.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: cholecalciferol Drug: Placebo oral capsule Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: All eligible patients were randomly assigned to either study (A) control(B) group
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of Vitamin D3 Supplementation on Antioxidant Enzymes Level in Vitamin D3 Deficient COPD Patients
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Experimental study

vitamin D Generic name -cholecalciferol (40,000IU)Dose-80,000 Dosage -2capsule/week for consecutive 26 weeks.

Drug cholecalciferol- ingredients -cholecalciferol (40,000 IU) Microcrystalline cellulose(58.1 gm),hydroxy toluene (.2mg),magnesium stearate(3mg0,gelatin capsule shell(1mg)

other name D-rise

Drug: cholecalciferol
80,000 IU(2 capsules)/week for 13 weeks and then according to the serum calcium and serum D level 40,000 IU/2 to 3 weeks for next 13 weeks
Other Names:
  • Vitamin D
  • Calcitriol

Placebo Comparator: Experimental control

Placebo oral capsule Dose-80,000 Dosage -2capsule/week for consecutive 26 weeks

placebo oral capsule-ingredients-microcrystalline cellulose,butylated hydroxy toluene

,magnesium stearate

other name D-rise

Drug: Placebo oral capsule
80,000 IU(2 capsules)/week for 13 weeks and then according to the serum calcium and serum D level 40,000 IU/2 to 3 weeks for next 13 weeks
Other Name: placebo treatment




Primary Outcome Measures :
  1. Effects of vitamin D3 supplementation on antioxidant enzymes level in vitamin D3 deficient COPD patients [ Time Frame: 6 months vitamin D3 supplementation ]
    vitamin D3 supplementation will cause increased antioxidant enzymes level in vitamin D3 deficient COPD patients



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pulmonologist diagnosed COPD patients

Duration of COPD: 1-10 years

Vitamin D3 deficient : Serum 25(OH)D <30 ng/ml

Age: >40years

Sex: Male

Socioeconomic status: Middle class

smoker

Exclusion Criteria:

  • With acute exacerbation of:

any other pulmonary diseases like - bronchial asthma respiratory tract infection bronchiectasis pneumothorax pleural effusion tuberculosis pulmonary fibrosis pneumonectomy or pulmonary lobectomy any cardiac disease, like -

  • unstable angina pectoris
  • congestive heart failure
  • myocardial infarction
  • cardiac arrhythmia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011930


Contacts
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Contact: Taskina Ali, MBBS,M.Phil 01711848845 taskinadr@gmail.com
Contact: Salma Anjum, MBBS 01768033336 salma.fmc@gmail.com

Locations
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Bangladesh
BSMMU Recruiting
Dhaka, Bangladesh, 1000
Contact: Billal Hossain, Masters    01818568702      
Contact: Golam Mostafa, Masters    01972843555      
Sponsors and Collaborators
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Investigators
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Study Director: Taskina Ali, MBBS,M.Phil Professor
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Responsible Party: Dr Salma Anjum, MD RESIDENT, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
ClinicalTrials.gov Identifier: NCT04011930    
Other Study ID Numbers: 7102
First Posted: July 9, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Vitamin D
Cholecalciferol
Calcitriol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents