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.

NCT04011930 | Unknown Phase 2 DMC

• 1 other identifier: 7102
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Effects of vitamin D3 supplementation on antioxidant enzymes level in vitamin D3 deficient COPD patients

  vitamin D3 supplementation will cause increased antioxidant enzymes level in vitamin D3 deficient COPD patients

  6 months vitamin D3 supplementation

Study Arms (2)

Experimental study

ACTIVE COMPARATOR

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

Experimental control

PLACEBO COMPARATOR

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

Interventions

cholecalciferol DRUG

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

Also known as: Vitamin D, Calcitriol

Experimental study

Placebo oral capsule DRUG

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

Also known as: placebo treatment

Experimental control

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

BSMMU

Dhaka, 1000, Bangladesh

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Cholecalciferol; Vitamin D; Calcitriol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Secosteroids; Membrane Lipids; Lipids; Dihydroxycholecalciferols; Hydroxycholecalciferols

Study Officials

• Taskina Ali, MBBS,M.Phil

  Professor

  STUDY DIRECTOR

Central Study Contacts

Taskina Ali, MBBS,M.Phil

CONTACT

01711848845; taskinadr@gmail.com

Salma Anjum, MBBS

CONTACT

01768033336; salma.fmc@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD RESIDENT

Model Details: All eligible patients were randomly assigned to either study (A) control(B) group

Study Record Dates

• First Submitted: July 4, 2019
• First Posted: July 9, 2019
• Study Start: March 1, 2019
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: July 9, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)